Clinical Trials

The purpose of this study is to evaluate immunogenicity of the vaccine, assessed at week 12, based on the increase in IgG anti-MUC1 antibody titer over the pre-vaccination levels, and to assess the safety throughout the trial and continued observation for 24 weeks.

A preventative MUC1 vaccine being tested in a clinical trial MAY13-01-01 in individuals with a history of advanced adenomas and an increased risk for colon cancer, gives 2 different outcomes.  About half of vaccinated individuals make a strong anti-MUC1 IgG (vaccine responders) and the other half do not (vaccine non-responders).  We have been analyzing differential gene expression in pre-vaccination PBMCs from these two groups to identify a gene expression signature that can predict response. We are now proposing to confirm and extend these studies by doing gene expression analysis at the single cell level rather than total PBMC.  ...

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.

The purpose of this study is to evaluate the activity of intravesical (IVE) administration of Cretostimogene Grenadenorepvec in patients with tissue pathology confirmed non-muscule invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease.

To determine the maximally tolerated dose (MTD) of intratumoral administration of an Edmonston strain measeles virus genetically engineered to express NAP (MV-s-NAP) in patients with metastatic breast cancer; to determine the safety and toxicity of on-time and serial administration of MV-s-NAP in patients with metastic breast cancer. 

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.

This phase I trial studies the side effects and the best dose of wild-type reovirus (viral therapy) when given with sargramostim in treating younger patients with high grade brain tumors that have come back or that have not responded to standard therapy. A virus, called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Sargramostim may increase the production of blood cells and may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus together with sargramostim may kill more tumor cells.

The purpose of this study is to look at the safety and immune response to a vaccine used in patients previously treated for HER2 (human epidermal growth factor receptor 2) positive breast cancer.

This is an open-label, multicenter, randomized, parallel groups study of GPS vs. best

available treatment (BAT) in patients with AML in second complete remission (CR2)

or in second complete remission with incomplete platelet recovery (CRp2). All

patients will have their historical bone marrow samples stained for WT1 via IHC by

central pathology review. The primary goal of the study will be to demonstrate an

advantage for GPS in overall survival in these patient populations. The study will

enroll approximately 116 patients and will be conducted at up to 50 investigational

sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are

in CR2 or ...

This randomized phase II trial studies how well lenalidomide improves immune response to pneumococcal 13-valent conjugate vaccine in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or monoclonal B cell lymphocytosis. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Lenalidomide may also improve the effectiveness of pneumococcal 13-valent conjugate vaccine that is used to prevent infection.

The purpose of this study is to determine the safety, effcicacy and tolerability of H2NVAC in patients with HER2-expressing DCIS in order to  prevent future invasive breast cancer among patients who are diagnosed with DCIS.

The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.

The purpose of this study is to evaluate the effectiveness and safety of PDS0101 administered in combination with Pembrolizumab in the first line treatment of adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).

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.

The purpose of this study is to evaluate the dose escalation and expansion of RP1 alone and combined with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary effectiveness.

The purpose of this study is to define the recommended dose, safety, tolerability, immunogenicity, and preliminary effectiveness of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent Non-Hodgkin's Lymphoma (NHL).

This phase I clinical trial investigates the side effects and the best dose of local (intrapleural measles virus therapy in treating patients with malignant pleural mesothelioma (MPM). The investigators anticipate that the intrapleural of the vaccine strain measles virus will enable the virus to specifically infect and kill cancer cells and spare, without damaging normal cells. Furthermore, the investigators expect the measles virus to trigger an anti-tumor immune response which will result in additional destruction of the tumor by immune cells.

The purpose of this study is to assess the side effects and best dose of a genetically engineered measles virus for treating patients who have a cancerous peripheral nerve sheath tumor that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent).

The purpose of this clinical study is to assess the safety and effectiveness of the immunotherapeutic product GSK 2302032A when given to Non-Small Cell Lung Cancer (NSCLC) patients, after tumor removal by surgery.

This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine will cause an immune response against proteins contained in the DRibble vaccine and the protein antigens targeted by this strong immune response will include common antigens shared by both the vaccine and the patient's tumor.

This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of attenuated Measles virus (MV-NIS) combined with nivolumab in patients with recurrent and metastatic (NSCLC).

The purpose of this study is to explore the effects of the measles virus on tumor immunity in a laboratory-based study.

The study will consist of two parts. The purpose of Phase Ib is to evaluate the safety and tolerability of the combination of TG4001 plus avelumab in patients with recurrent or metastatic HPV-16 positive advanced malignancies. The purpose of Phase II part 1 is to evaluate the effectiveness of TG4001 combined to avelumab in terms of Overall Response Rate (ORR) by using RECIST 1.1 in patients with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies including oropharyngeal SCCHN. The purpose of Phase II part 2 is to compare the Progression-Free Survival (PFS) of TG4001 in combination with avelumab vs avelumab alone in patients with recurrent or metastatic ...

The purpose of this study is to investigate the combination of standard of care treatment of TAS-102 and the experimental peptide vaccine, PolyPEPI1018, to learn more about the side effects of combination and to collect information on how cancer responds to this combination.

PolyPEPI1018 peptide vaccine is a mixture of 6 synthetic peptides and the adjuvant Montanide™ and is used to immunize against proteins present on the surface of tumor cells. In a high number of patients, this mixture will activate the body’s immune cells, called T cells. T cells fight infections and can also kill cancer cells.

Participants will receive TAS-102 and PolyPEPI1018 which ...

The purpose of this study is to determine the safety of VSV-IFNβ-NIS in combination with pembrolizumab, followed by expansion to examine effectiveness of combination therapy in patients with refractory Non-Small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC).

The purpose for this study is to find out if MEDI5395 and durvalumab will work and be safe for the treatment of solid tumors.

The purpose of this study is to explore the effectiveness and safety of UV1 administered with GM-CSF in combination with nivolumab and ipilimumab.

UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma.

The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, pancreatic cancer, and shared neoantigen-positive tumors.

Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and tolerability of the combination and to identify a RP2D.

Part B: Phase 2 design which will randomize subjects 1:1 to either MEDI4736 alone or MEDI4736+ADXS11-001 in subjects who have failed at least 1 prior systemic treatment for their recurrent/persistent or metastatic cervical cancer.

The primary purposes of this study are to is to assess safety and tolerability of IV administration of TVH vaccine alone and in combination with HER2 antibodies in patients with advanced cancer.

To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.

The purpose of this study ia to determine the safety and tolerability of personalized neoantigen peptide administered in combination with pembrolizumab to patients with advanced solid tumors. Patients' tumors will be sequenced during a pre-registration component or will have had successful sequencing pre-study. A personalized neoantigen peptide vaccine containing up to 20 unique peptides will be manufactured for each qualifying patient based on the results.

The purpose of this study is to evaluate how well multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, 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. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide may work better ...

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.

This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.

The purpose of this study is to evaluate the side effects of talimogene laherparepvec and radiation therapy to see how well they work in treating patients with newly diagnosed soft tissue sarcoma that can be removed by surgery. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors. Giving talimogene laherparepvec and radiation therapy may work better in treating patients with soft tissue sarcoma.

The purpose of this study is to evaluate the side effects of vaccine therapy in treating patients with glioblastoma that has come back. Vaccines made from a person's white blood cells mixed with tumor proteins from another person's glioblastoma tumors may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy may work better in treating patients with glioblastoma.

The purpose of this study is to bioengineer a novel vesicular stomatitis virus (VSV) to express extracellular matrix (ECM) destructing enzymes to overcome desmoplastic pancreatic adenocarcinoma (PDAC) tumor microenvironment and assess the oncolytic virus (OVs’) therapeutic safety and efficacy as monotherapy and in combination with immune checkpoint inhibitors (ICIs) in preclinical settings. This effectiveness will be investigated in vitro, ex vivo and in vivo.

The purpose of this study is threefold:  the first aim is to use patient-derived fresh tumor tissue to create cell lines and 3D tumor models (i.e. organoids) that preserve the characteristics of the original tumor. The preservation of the original tumor's drug resistance/response profile will be a major focus of this aim. The second aim is to conduct high-throughput testing of various drugs (e.g., virotherapy, immunotherapy) on these cell lines and 3D tumor models. The completion of the second aim is an important step towards developing a platform that can help guide treatment decisions for future patients, based on the drug ...

This randomized phase II trial studies how well giving vaccine therapy with or without bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a person's own tumor tissue may help the body build an effective immune response to kill tumor cells that may remain after surgery. 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. It is not yet known whether giving vaccine ...