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A Study of Adding AMG 479 to First Line Chemotherapy in Patients with Optimally Debulked Epithelial Ovarian Cancer
Rochester, MN
The purpose of this study is to determine the value of adding AMG 479 (a fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin (first line chemotherapy) for the treatment of patients who have ovarian epithelial cancer that has been surgically removed to less than 1 cm thick.
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Accelerating Gastrointestinal Recovery
Rochester, MN
This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.
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A Study to Assess Dynamic Changes in Plasma Proteome to Identify Early Detection and Treatment Response Biomarkers for HGSOC
Rochester, MN
This study aims to identify candidate High Grade Serous Cancer (HGSC) early detection and chemotherapy treatment response biomarkers. For the purpose of this study we define high grade serous cancers to include invasive cancers arising in the ovary and/or fallopian tubes (FT). Using mass spectrometry we will deeply profile and quantitate dynamic changes in the plasma proteome and N-gylcocapture sub-proteome that occur as a consequence of surgical debulking and platinum-based chemotherapy.
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Study of SC-003 in Subjects With Platinum-Resistant/Refractory Ovarian Cancer
Rochester, MN
The purpose of this Phase 1a/1b study of SC-003 in patients with platinum-resistant/refractory ovarian cancer is to characterize the safety and tolerability of SC-003, identify the maximum tolerated dose (MTD) of SC-003, and identify the recommended Phase 1b dosing(s) and schedule(s) of SC-003. SC-003 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy.
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A Study for Women who have Platinum Resistant Ovarian Cancer to Evaluate EC145 Combined with Pegylated Liposomal Doxorubicin, Compared to Pegylated Liposomal Doxorubicin Alone
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the progression-free survival in women who have platinum-resistant ovarian cancer, who receive combination therapy with EC145 and pegylated liposomal doxorubicin (EC145+PLD) with those who receive PLD alone.
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A Study to Learn About How Women Metabolize and Respond to Opioids When Used for Managing Post-operative Pain
Rochester, MN
The goal of this study is to examine the current and (potential) future therapeutic relevance of PGx testing for surgical ovarian cancer patients in order to improve patient clinical care at Mayo Clinic with more effective and efficient prescribing of opioid medications.
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Olaparib Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Rochester, MN
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
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Improving Genetic Referral Rates in Women with Ovarian Cancer
Rochester, MN
The purpose of this study is to determine if the implementation of a genetic referral toolkit increases the genetic referral rates for women with epithelial ovarian cancer at Mayo Clinic Rochester and to determine barriers to genetics counseling and testing from a patient perspective
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OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.
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Auranofin and Sirolimus in Treating Participants With Ovarian Cancer
Rochester, MN
This phase II trial studies how well auranofin and sirolimus work in treating participants with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to decrease the body?s immune response and may increase blood cell count.
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A Study to Evaluate Regulation of the Metabolism of T-Cells by the Tumor Microenvironment in Ovarian Cancer Metastasis
Scottsdale/Phoenix, AZ
The purpose of this study is to analyze how the immune cell repertoire changes during early and late metastasis which could shed light into how the tumor microenvironment in metastatic disease becomes tumor permissive.
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Veliparib and Topotecan Hydrochloride in Treating Patients with Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase I/II trial studies the side effects and best dose of veliparib and topotecan hydrochloride and to see how well they work in treating patients with solid tumors, relapsed or refractory ovarian cancer, or primary peritoneal cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib with chemotherapy may kill more tumor cells.
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ADVANCE
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this research study is to understand the views and experiences of African American women with a diagnosis or who support a family member with breast or ovarian cancer. We also want to know participant thoughts on genetic testing for cancer risk.
This is a qualitative interview study. Study participation involves talking on the phone or videoconference (e.g., Zoom) for about 1 hour with a researcher.
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Fat Emulsion in Preventing Hypersensitivity Reactions in Patients With Cancer Receiving Carboplatin or Oxaliplatin
Rochester, MN
This randomized pilot trial studies how well fat emulsion works in preventing hypersensitivity reactions in patients with cancer receiving carboplatin or oxaliplatin. Giving lipids before chemotherapy may prevent some drug reactions from carboplatin or oxaliplatin.
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A Study to Evaluate Immune Response Changes to Ovarian Cancer During Chemotherapy
Rochester, MN
The study will determine whether the type and number of immune cells (white blood cells) in ovarian cancer tumors after initial chemotherapy impacts ovarian cancer patient outcomes.
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A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus
Rochester, MN
Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival are low. There is a current belief that this cancer starts in the fallopian tubes and progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian tubes and the uterus, there is a constant flow of mucus which has only one exit through the cervix and out the vagina. Proteins that are generated within the entire female reproductive system are trapped into this viscous fluid and eventually released as waste. When a routine PAP test is performed, a sample of this ...
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A Study to Compare Two Surgical Procedures in Women With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Rochester, MN
This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.
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Patient Experience and Understanding of Genetic Testing in Ovarian Cancer
Rochester, MN
The purpose of this study is to investigate the experience and understanding of patients with ovarian cancer in relation to genetic testing by means of one-on-one qualitative interviews and survey.
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A Open Label Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression
Rochester, MN
The purpose of this study is to obtain an estimate of the biochemical response rate as determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma. CA125 response is defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days after initial evaluation (baseline is defined as the higher value of 2 pre-treatment CA125 assessments).
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A Study Evaluating Pembrolizumab and Epacadostat in Treating Participants With Recurrent, Persistent, or Progressive Ovarian Clear Cell Carcinoma
Rochester, MN
The purpose of this trial is to assess how well pembrolizumab and epacadostat work in treating participants with ovarian clear cell carcinoma that has come back, remains despite treatment, or is growing, spreading, or getting worse. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and epacadostat may work better in treating participants with ovarian clear cell carcinoma.
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ADVANCE 2: ADdressing Views of African AmericaNs on CancEr Screening
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this research study is to understand the views and experiences of Non-Hispanic Black women with a diagnosis or who support a family member with breast or ovarian cancer. We also want to know participant thoughts on genetic testing for cancer risk and research participation.
This is a qualitative interview study. Study participation involved talking on the phone or videoconference (e.g., Zoom) for about 1 - 1 1/2 hours with a researcher.
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Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN
This phase II trial studies how well olaparib and cediranib maleate work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study to Evaluate AVB-S6-500 with Paclitaxel vs Paclitaxel in Patients with Platinum-resistant Recurrent Ovarian Cancer
Rochester, MN
The purpose of this study is to evaluate AVB-S6-500 in combination with paclitaxel (Pac) in patients with platinum resistant recurrent ovarian cancer to compare the effectiveness and of AVB-S6-500 in combination with Pac versus placebo plus Pac.
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MV-NIS Infected Mesenchymal Stem Cells in Treating Patients With Recurrent Ovarian Cancer
Rochester, MN
This phase I/II trial studies the side effects and best dose of oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) infected mesenchymal stem cells and to see how well it works in treating patients with recurrent ovarian cancer. Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian cancer cells.
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Ovarian and Uterine Cancer Patients' Cancer Diagnosis and Treatment-Related Characteristics from Medical Records
Rochester, MN
The purpose of this study is to extract ovarian and uterine cancer patients' phenotypes at diagnosis and cancer treatments (side-effects, symptoms and clinical test values) from medical records using medical informatics approaches.
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A Study to Evaluate the Venn Ovarian CAncer Liquid Biopsy
Jacksonville, FL
The primary purpode of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the InterVenn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned.
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Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to identify the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them ...
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Use of Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy and Risk of Malignancy in Genetic Mutation Carriers
Rochester, MN
The purpose of this study is to determine if an increase risk of malignancy occurs in these patients if they use hormonal replacement therapies after a risk reducing salpingo-oophorectomy
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A Study to Compare Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian or Primary Peritoneal Cancer
Albert Lea, MN; Rochester, MN
The purpose of this study is to evaluate how well letrozole, with or without paclitaxel and carboplatin, works in treating patients with stage II-IV low-grade serous carcinoma of the ovary or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is ...
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A Study of the Effectiveness and Safety of Pembrolizumab (MK-3475) for Women with Advanced Recurrent Ovarian Cancer
Rochester, MN
The purpose of this study is to assess the effectiveness and safety of pembrolizumab (MK-3475) for the treatment of women with advanced ovarian cancer who have had recurring disease following front line platinum-based treatment and debulking surgery.
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Veliparib and Floxuridine in Treating Patients With Metastatic Epithelial Ovarian, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This phase I trial studies the side effects and best dose of veliparib when given together with floxuridine in treating patients with metastatic epithelial ovarian, primary peritoneal cavity, or fallopian tube cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with floxuridine may kill more tumor cells.
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A Study to Evaluate Immunotherapy and Ovarian Function Among Pre-menopausal Melanoma Survivors
Rochester, MN
The purposes of this study are to analyze the ovarian function of female premenopausal melanoma survivors who have undergone immunotherapy, and compare with data from age-matched controls, prospectively investigate ovarian function in premenopausal women with melanoma undergoing immunotherapy, and to identify the impact of ovarian function change on the frequency and function of CD8+ T cells during immunotherapy.
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A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.
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Chemotherapy Toxicity On Quality of Life in Older Patients with Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This trial studies the chemotherapy toxicity on quality of life in older patients with stage I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.
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Pembrolizumab With Chemotherapy and With/Without MK-4830 for Treating Participants With Ovarian Cancer
Jacksonville, FL
The purpose of this study is to evaluate whether the reduction from baseline in circulating tumor DNA at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + Standard of Care (SOC) therapy.
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A Study of Tazemetostat in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Endometrial Cancer
Rochester, MN
The purpose of this trial is to study how well tazemetostat works in treating patients with ovarian, primary peritoneal, or endometrial cancer that has come back. Drugs used in chemotherapy, such as tazemetostat, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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Carboplatin and Gemcitabine Hydrochloride With or Without VX-970 in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This randomized phase II trial studies the side effects and how well carboplatin and gemcitabine hydrochloride with or without ATR kinase inhibitor VX-970 work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent) and has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. ATR kinase inhibitor VX-970 may stop the growth of tumor cells by blocking ...
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Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Jacksonville, FL; Rochester, MN
This pilot, phase II trial studies how well everolimus and letrozole work in treating patients with hormone receptor positive ovarian, fallopian tube, or primary peritoneal cavity cancer that has come back. Everolimus and letrozole may stop the growth of tumor cells by blocking some the enzymes needed for cell growth.
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Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
Jacksonville, FL
UP-NEXT is a double-blind, randomized, placebo controlled study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion for patients once every four weeks. Patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC) including fallopian tube and primary peritoneal cancer expressing high levels of NaPi2b.
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Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Rochester, MN
The purpose of this study is to see if the investigators can improve the treatment of this type of cancer. They want to find out what effects, good and/or bad, giving heated chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has on the patient and this type of cancer. The goal of HIPEC is to expose any cancer left in the abdomen after surgery to high doses of chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to get into and kill the cancer cells. The drug used for HIPEC will ...
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Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to determine the maximum tolerated dose of the combination of ABT-888 and weekly topotecan in adult patients with advanced solid tumors, and to identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors.
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MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This randomized phase II trial studies how well oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) compared to investigator's choice chemotherapy works in treating patients with ovarian, fallopian, or peritoneal cancer. Measles virus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.
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DNA Damage Using hERY-MNT Technology can Predict Chemotherapy Induced Toxicity in Women with Ovarian Cancer
Rochester, MN
The purpose of this study is to understand changes that take place in the blood of patients with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. This portion of the study is to understand the changes that occur in your blood during and after treatment with carboplatin and paclitaxel chemotherapy in women with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
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A Study of Cediranib and Olaparib Combined, Compared to Either Drug Alone, or to a Standard Chemotherapy in Treating Patients who have a Return of Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
La Crosse, WI; Rochester, MN; Mankato, MN
The purpose of this study is to see how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping ...
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A Study Comparing Gemcitabine with or without AZD 1775 in Treating Patients with Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN
The purpose of this study is to compare gemcitabine hydrochloride in combination with AZD 1775 to gemcitabine hydrochloride given alone to treat patients with ovarian, primary peritoneal, or fallopian tube cancer that has returned after a period of time. Gemcitabine hydrochloride may prevent tumor cells from multiplying by damaging their deoxyribonucleic acid (DNA) molecules that contain instructions for the proper development and functioning of cells, which in turn stops the tumor from growing. AZD 1775 may block specific protein activity and may increase the effectiveness of gemcitabine hydrochloride by preventing the protein from repairing damaged tumor cells without causing harm to normal cells. It ...
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A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
Rochester, MN
This is an open label, single-arm, phase II study. The study population is adult patients with asymptomatic recurrent ovarian cancer who have an elevation in their CA-125 level.
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Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery
Rochester, MN
This research trial studies comprehensive patient questionnaires in predicting complications in older patients with gynecologic cancer undergoing surgery. Comprehensive patient questionnaires completed before surgery may help identify complications, such as the need for assistance in taking medications, decreased mobility, decreased social activity, and falls, and may improve outcomes for older patients with gynecologic cancer.
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Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN
This randomized phase II trial studies how well ATR kinase inhibitor M6620 (M6620) and gemcitabine hydrochloride work compared to standard treatment with gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement (recurrent). ATR kinase inhibitor M6620 may stop the growth of tumor cells by blocking an enzyme needed for cell growth, and may also help gemcitabine hydrochloride work better. Gemcitabine hydrochloride is a drug used in chemotherapy that works to stop the growth of tumor cells by blocking cells from growing and repairing themselves, causing them ...
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Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Subjects With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Rochester, MN
The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab and Pegylated Liposomal Doxorubicin as Treatment for Ovarian Cancer. (PROTA)
Rochester, MN
The purpose of this study is to evaluate the safety [including dose-limiting toxicities (DLTs)] of the combination therapy of TILT-123 and pembrolizumab in patients with platinum resistant or refractory ovarian cancer.
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A Study of Niraparib Combined with Pembrolizumab (MK-3475) in Patients who have Triple-Negative Breast Cancer or Ovarian Cancer
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of combined treatment with niraparib and pembrolizumab (MK-3475) in patients who have triple-negative breast cancer that is advanced or has spread, or ovarian cancer that has returned after previous treatment.
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A Study of Pembrolizumab Alone or Combined with CC-486 for Patients with Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer
Rochester, MN
The purpose of the study is to determine the best dose of CC-486 (oral azacitidine) combined with pembrolizumab for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer.
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Novel Technique for Cell Cultures in Gynecologic Oncology
Rochester, MN
The purpose of this study is to develop cell cultures specifically for the study of gynecological carcinomas using in vivo zebrafish tissue modeling, and to establish a robust and reliable assay for predicting response to treatment on an individualized basis for Mayo Clinic cancer patients.
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Pembrolizumab in Treating Participants With Recurrent Ovarian Cancer
Rochester, MN
The purpose of this study is to evaluate how well pembrolizumab works in treating participants with ovarian cancer that has come back after previous treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
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A Study to Evaluate TG4050 in Ovarian Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability, as well as some activity parameters, of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.
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A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
Rochester, MN
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.
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A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Rochester, MN
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and ...
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Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy
Rochester, MN
This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.
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Olaparib or Cediranib Maleate and Olaparib Compared With Standard Platinum-Based Chemotherapy in Treating Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
La Crosse, WI; Rochester, MN; Mankato, MN; Scottsdale/Phoenix, AZ
This randomized phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin ...
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A Study to Evaluate Ribociclib Plus Letrozole to Treat Cancer of the Ovary, Fallopian Tube or Peritoneum
Rochester, MN
The purpose of this study is to evaluate the response to treatment with Ribociclib and Letrozole in patients with low-grade serous cancer of the ovary, fallopian tube or peritoneum.
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PLX038 for the Treatment of Metastatic Ovarian, Peritoneal, and Fallopian Tube Cancers
Rochester, MN
The purpose of this study is to determine the response rate to PLX-038 in patients with metastatic ovarian, primary peritoneal, and fallopian tube cancers that are resistant to platinum drugs.
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First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b
Jacksonville, FL; Rochester, MN
The primary objective of this study is to determine the confirmed investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) in patients with higher sodium-dependent phosphate transport protein 2b (NaPi2b) expressing platinum-resistant high-grade serous ovarian cancer (HGSOC), including cancers of ovarian, fallopian tube or primary peritoneal origin)
Note: Mayo Clinic is only participating in the Phase 2 - Cohort 3 (UPLIFT) portion of the study. Mayo Clinic will not be participating in the QTC sub-study.
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Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well Avatar-directed chemotherapy works in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that does not respond to platinum anti-cancer drugs. Drugs used in chemotherapy, such as paclitaxel, gemcitabine hydrochloride, pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Using an Avatar, a living tumor sample with similar genetic characteristics to ...
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WISP (Women Choosing Surgical Prevention)
Rochester, MN
This phase II trial studies how well surgery works in preventing ovarian cancer in patients with genetic mutations at risk of ovarian cancer. Risk reducing salpingo oophorectomy (RRSO) is surgery to remove the fallopian tubes and ovaries at the same time. Interval salpingectomy with delayed oophorectomy (ISDO) is surgery to remove the fallopian tubes. It is not known whether ISDO works better than RRSO at lowering risk of ovarian cancer and improving the sexual function and psychosocial well-being in patients with genetic mutation.
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A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Jacksonville, FL
This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in patients with Stage III or IV ovarian cancer. Patients must have completed front-line platinum based regimen with a physician-assessed response of Complete Response (CR) or Partial Response (PR). Additionally, patients must have a normal or >90% decrease in cancer antigen 125 (CA-125) following front-line platinum treatment. The study will assess the efficacy of niraparib as maintenance treatment, as measured by PFS.
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Changes in Blood Components in Patients with Ovarian Cancer
Rochester, MN
The purpose of this study is to assemble a collection of serial plasma biospecimens from women with ovarian, primary peritoneal, or fallopian tube cancer for future research projects to identify changes in levels of various plasma components that occur during the course of ovarian cancer, including changes that occur with debulking surgery, chemotherapy, disease relapse, and subsequent therapy.
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ABT-888 With Cyclophosphamide in Refractory BRCA-Positive Ovarian, Primary Peritoneal or Ovarian High-Grade Serous Carcinoma, Fallopian Tube Cancer, Triple-Negative Breast Cancer, and Low-Grade Non-Hodgkin's Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to test an experimental combination of two drugs, ABT-888 and Cyclophosphamide (CP), which we hope may eventually lead to promising new therapies for cancer.
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Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a double-blind, randomized, Phase II trial. Patients with advanced ovarian cancer that has not progressed following completion of standard-of-care chemotherapy are eligible to participate. Patients will be randomized to either the vaccine regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be administered as a consolidation therapy beginning within one year of the last administration of platinum.
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Metformin Hydrochloride and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Rochester, MN
This randomized phase II trial studies how well metformin hydrochloride and combination chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive to the drugs. Studying samples of blood and tissue in the laboratory from patients receiving metformin hydrochloride may help doctors ...
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Ovarian Cancer Microbiome Signatures
Rochester, MN
The purpose of this study is to characterize the microbiome in the genital tract and in the peritoneal cavity of subjects with ovarian, fallopian tube, and primary peritoneal cancer.
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Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Jacksonville, FL; Rochester, MN
This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others ...
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A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to compare the effectiveness and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy.
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A Study to Understand Symptoms from Olaparib
Rochester, MN
The purpose of this study is to gather real-world, patient-reported experiences of ovarian cancer patients who have been prescribed olaparib; this experience will be captured in patients’ own words with qualitative research methodology.
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Establishment of Preclinical Models from Patients with Gynecological Malignancies
Rochester, MN; Scottsdale/Phoenix, AZ
Effective treatments for recurrent gynecological cancer are lacking, and there is a need for novel therapeutic options. One of the barriers to improving outcomes in this subgroup of patients is the paucity of tumor models that can mimic patient characteristics to study novel therapies. Patient-derived xenograft (PDX) models are considerate the most representative pre-clinical model of human cancer, recapitulating the key characteristics of the original patient tumor. Other preclincal models to test drug effcicacy includes ex vivo 3D culture and 2D culture systems. In this study, we make and test preclinical models of gynecological cancers (ovarian, fallopian tube, peritoneal, uterine, ...
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Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of part one of this study is to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and safety profile of Q901 monotherapy when administered via intravenous (IV) infusion once-weekly (QW) for 4 weeks and once every 2 weeks (Q2W) thereafter. Also, to establish for future clinical development the recommended Phase 2 dose (RP2D) of Q901 monotherapy when administered via IV infusion QW for 4 weeks and Q2W thereafter.
The purpose of part two of this study is to evaluate safety and tolerability and evidence of anticancer activity of Q901 as monotherapy and in combination with pembrolizumab. In Part 2 Cohort 1, ...
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A Safety to Evaluate the Safety and Effectiveness of Pressurized Intraperitoneal Aerosolized Chemotherapy in Ovarian, Uterine, Colorectal, and Gastric Cancer Patients
Jacksonville, FL
The purpose of this study is to evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 2 groups of patients with peritoneal carcinomatosis (PC), either due to primary ovarian, uterine, or gastric carcinoma (Arm 1) or to primary colorectal carcinoma (Arm 2), based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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Biospecimen Resource for Ovarian Cancer Research
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to create and maintain a resource of biospecimens and annotated clinical data for research projects focused on ovarian cancer. Individuals who are undergoing evaluation for a pelvic mass are recruited, as well as age-matched community controls who have never had ovarian, primary peritoneal or fallopian tube cancer.
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A Study of SC‑004 in Subjects With Advanced Solid Tumors
Rochester, MN
This is a two-part study consisting of Part A (dose regimen finding) followed by Part B (dose expansion). Part A (dose regimen finding) will allow definition of the maximum tolerated dose (MTD) through dose escalation and possible dose interval modification. In Part B (dose expansion), potential therapeutic doses may be studied with SC-004 as monotherapy and SC-004 in combination with ABBV-181 in disease-specific cohorts.
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Combination of Serabelisib and Insulin Suppressing Diet in Subjects With Advanced Solid Tumors with PIK3CA Mutations
Rochester, MN
The purpose of this study is to evaluate the feasibility of optimizing the safety and tolerability of serabelisib when combined with an Insulin Suppressing Diet (ISD) with a goal of reducing side effects and enhancing anticancer activity.
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Study of AMG 650 in Adult Participants With Advanced Solid Tumors
Rochester, MN
To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
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Cyclophosphamide and Vaccine Therapy in Treating Patients with Stage II-III Breast, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN
This study is being done to gather information. The study will provide important information related to the safety and the effect of the vaccine on a patient's immune system. What researchers learn from this study could possibly be used in the future to prevent or delay recurrence of breast or ovarian cancers.
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A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of Part A of this study is to characterize the safety, tolerability, and biological effects of CUE-102. The goal of Part B is to expand the safety and immune activity data at the RP2D identified in Part A, and to evaluate antitumor activity at this dose.
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A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of ZB131 in patients with solid tumors where prevalence of CSP expression is high.
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Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Rochester, MN
This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with gynecological cancer after undergoing surgery. Serum bovine immunoglobulin supplementation may improve the quality of life of patients with gynecological cancer.
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Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
Rochester, MN
This is a Phase 1b, open label, multi-center study of CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1.
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Prehabilitation
Rochester, MN
Physical activity plays an important role in reducing the adverse effects of cancer treatment. There are few studies using prehabilitation to improve peri-operative outcomes in patients undergoing cancer surgery. This study will pilot a program of structured activity for women undergoing neoadjuvant chemotherapy with the intent to improve their physical state prior to surgical intervention and thus improve outcomes.
It has been shown that patients with advanced ovarian cancer may suffer from high levels of cancer –specific distress, depression and anxiety. It has also been proposed that psychological resilience can favorably affect psychological and treatment-related outcomes in cancer ...
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The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Albert Lea, MN; Mankato, MN
The purpose of this study is to determine whether a common virus, cytomegalovirus (CMV), may increase fatigue and other symptoms following treatment for ovarian cancer.
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Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
Rochester, MN
This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.
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Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well ribociclib and letrozole work in treating patients with estrogen receptor (ER) positive ovarian, fallopian tube, primary peritoneal, or endometrial cancer that has returned (come back) after a period of improvement. Ribociclib may stop the growth of tumor cells by blocking some enzymes needed for cell growth. Cancer cells that are estrogen receptor positive may need estrogen to grow. Letrozole lowers the amount of estrogen made by the body and this may stop the growth of tumor cells that need estrogen to grow. Giving ribociclib together with letrozole may be an effective treatment in ...
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MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment
Scottsdale/Phoenix, AZ
This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.
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An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and tolerability, and determine the maximum tolerated dose of INCB062079 in subjects with advanced hepatocellular carcinoma and other malignancies.
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A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
Patients in the study will be treated with Melphalan/HDS and will receive up to 6 total treatments. This study will evaluate the safety and effects of the treatment.
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Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1
Rochester, MN
This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel immunotherapy agent designed to target dendritic cells and stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305 with pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1 therapy.
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Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This phase I trial studies the side effects and best dose of olaparib and onalespib when given together in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery or ovarian, fallopian tube, primary peritoneal, or triple-negative breast cancer that has come back. Olaparib and onalespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study of Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Scottsdale/Phoenix, AZ
The primary purpose of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.
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A Study of Navicixizumab Monotherapy or in Combination in Patients With Select Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the antitumor activity of navicixizumab monotherapy or in combination with paclitaxel or irinotecan in patients with advanced solid tumors including:
- Cohort A: Colorectal cancer (CRC);
- Cohort B: Gastric and gastroesophageal junction (GEJ) cancer;
- Cohort C: Triple-negative breast cancer (TNBC);
- Cohort D: Platinum-resistant/refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer (ovarian cancer).
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A Study of PY314 in Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
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A Study to Evaluate Precision Pharmacogenomics in Cancer Patients
Scottsdale/Phoenix, AZ
THe purpose of this study is to examine the current and (potential) future therapeutic relevance of pharmacogenomics (PGx) testing for a cohort of cancer patients in order to improve quality of life (QOL) in patients receiving clinical care at Mayo Clinic.
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Temsirolimus and Bevacizumab in Treating Patients with Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may ...
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A Study to Evaluate the Effectiveness and Safety of Rivaroxaban as Prophylaxis Treatment for Venous Thromboembolism (VTE) in Ambulatory Cancer Patients
Rochester, MN
The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult patients with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.
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A2B101-101: Obtaining Solid Tumor Tissue from Subjects Having Surgical Resection for Certain Tumor Types and Leukapheresis for CAR T-cell Therapy Manufacturing
Rochester, MN; Jacksonville, FL
The primary objectives for this study are:
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status
- The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status
- Percentage of screened subjects experiencing loss ...
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Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma, gynecological cancers, or other malignancies that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing ...
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A Study of CART-TnMUC1 in Patients With TnMUC1-Positive Advanced Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, feasibility, and preliminary effectiveness of the administration of genetically-modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells).
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A Study to Develop a Biorepository of Blood Samples from Cancer Patients Participating in the Gemini (IRB 19-006717) Protocol
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to develop a biorepository of blood samples from cancer patients participating in the Gemini (IRB 19-006717) protocol. These samples will be used for future biomarker discovery and other translational studies.
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A Study Evaluating MM-310 in Patients With Solid Tumors
Rochester, MN
MM-310 is a liposomal formulation of a docetaxel prodrug that targets the EphA2 receptor on cancer cells. Docetaxel is an approved chemotherapeutic drug.This study is a Phase 1 open-label study of MM-310 in patients with solid tumors. In the first part of the study, MM-310 will be assessed as a monotherapy until a maximum tolerated dose (MTD) is established. After an MTD of MM-310 as a monotherapy is established, an expansion cohort and MM-310 in combination with other therapies will be assessed.
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A Study of SGN-B7H4V in Advanced Solid Tumors
Jacksonville, FL
The purpose of this study is to test the safety and side effects of a drug called SGN-B7H4V in participants with solid tumors. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A ...
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An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
Rochester, MN
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
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A Blood Collection Protocol to Study the Immune Responses of Cancer Patients with Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic ...
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Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors
No Locations
Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule) that, in preclinical studies, has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.
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A Study of Mogamulizumab Combined with Nivolumab in Patients who have Locally Advanced or Metastatic Solid Tumors
Jacksonville, FL
The purpose of this study is to characterize the safety and tolerability of combined treatment with mogamulizumab and nivolumab, and also determine the maximum tolerated dose and the recommended fixed dose for the treatment of patients who have locally advanced or metastatic solid tumors.
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Mayo Clinic Cancer Genomics Service Line Biorepository
Eau Claire, WI; Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of the study is to create a database of clinical information and a repository of biological specimens for genetic, molecular and microbiological research to better understand hereditary cancer and help develop new therapies and preventive strategies.
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hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
Rochester, MN; Scottsdale/Phoenix, AZ
This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of six treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.
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Study of TJ011133 in Participants With Relapsed/ Refractory Advanced Solid Tumors and Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
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Gemini Study to Evaluate the Integration of Cancer Genetic Testing into a Cancer Clinical Practice at Mayo Clinic at Arizona
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic cancer clinics.
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cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)
Rochester, MN
The purpose of this multicenter prospective observational case-control study is to train and validate Adela’s cfMeDIP-seq based methylome profiling platform to detect and differentiate multiple cancer subtypes. In addition, this study includes longitudinal follow-up for a subset of participants to train and validate the methylome profiling platform to detect minimal residual disease and recurrence.
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A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose for evaluation in these patients.
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Study of E7386 in Participants With Selected Advanced Neoplasms
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.
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Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations
Jacksonville, FL; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.
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Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN
The purpose of this study is to collect blood and tissue samples from patients with and without cancer to evaluate laboratory tests for early cancer detection which may help researchers develop tests for the early detection of cancers.
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The Circulating Cell-free Genome Atlas Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.
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A Study to Evaluate Exercise for Cancer Patients at Risk of Falling
Rochester, MN
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.