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Search Results 1-4 of 4 for checkpoint inhibitor, cancer

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Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis

Jacksonville, FL
- See Details
Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study
This is a prospective, pilot, single arm study to evaluate the incidence of IIC in patients with solid malignancies receiving VSL#3 and ICIs. Given the fact that the effects of over-the-counter probiotics in reducing the risks of IIC remains largely unknown. Given that this is a small pilot study to generate preliminary data, there will be no randomization in this trial. The results of this trial will provide a foundation for the future development of larger definitive randomized controlled trials. Patients with solid malignancy who will be receiving ICI as per standard of care will be enrolled in this trial. Patients will receive VSL#3® 450B sachets probiotics, which will be provided as part of this trial, at least 3 days but preferably 1-2 weeks prior to starting on ICIs. Patients will be followed per standard of care during ICI treatment and continue VSL#3 for 12 more weeks while on ICI. Patients will complete dietary questionnaire and have research blood draws and stool collections at baseline prior to starting VSL#3 and 3 additional time points. Adherence to the probiotic schedule will be captured in a study diary. Adverse events as well as incidence and severity of IIC will be graded using NCI CTCAE version 5. Patients will have imaging performed per standard of care.

Primary Goal

To evaluate the incidence of immune checkpoint inhibitors (ICI)-induced colitis (IIC) in patients with solid malignancies receiving over-the-counter multi-strain probiotic blend and ICIs in both cohorts: (1) anti-CTLA-4 +/- anti-PD-1/PD-L1, and (2) anti-PD-1/PD-L1 +/- chemo.

Secondary Goals

To evaluate the safety of multi-strain probiotic blend in cancer patients receiving ICIs.

To evaluate the clinical outcomes related to IIC, including the incidence of IIC, hospitalization, treatment delays, and administration of immunosuppressants.

Exploratory Goals

To evaluate changes in gut microbiome with ICIs and multi-strain probiotic blend.

To evaluate changes in immune response with ICIs and multi-strain probiotic blend.
Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Open for enrollment
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Site IRB:
Jacksonville, Florida: 21-012363

NCT ID:
NCT06508034

Sponsor Protocol Number:
MC210304

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

Scottsdale/Phoenix, AZ, Rochester, MN, Jacksonville, FL

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Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to compare the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Scottsdale/Phoenix, Ariz.	Open for enrollment
Jacksonville, Fla.	Open for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 23-011318
- Scottsdale/Phoenix, Arizona: 23-011318
- Jacksonville, Florida: 23-011318
NCT ID:
NCT05812807
Sponsor Protocol Number:
A012103

A Study to Evaluate the Safety, Tolerability, and Determine the Optimal Dose for the Expansion Cohorts of VSV-IFNβ-NIS in Combination with Pembrolizumab in Patients with Refractory Solid Tumors

Rochester, MN
- See Details
A Study to Evaluate the Safety, Tolerability, and Determine the Optimal Dose for the Expansion Cohorts of VSV-IFNβ-NIS in Combination with Pembrolizumab in Patients with Refractory Solid Tumors
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  1/2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

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).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Open for enrollment
View complete study & contact information

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Site IRB:
Rochester, Minnesota: 18-011203

NCT ID:
NCT03647163

Sponsor Protocol Number:
VYR-VSV2-202
Gut and Tumor Microbiome in Patients With Advanced ER-positive and HER2-negative Breast Cancer or Advanced Melanoma Undergoing PD-1 Checkpoint Inhibitor Therapy.

Jacksonville, FL
- See Details
Gut and Tumor Microbiome in Patients With Advanced ER-positive and HER2-negative Breast Cancer or Advanced Melanoma Undergoing PD-1 Checkpoint Inhibitor Therapy.
- Study type:
  Observational
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
About this study

The purpose of this study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer or melanoma to see how the bacteria in the body affect cancer and how well it responds to treatment. By comparing samples and data from multiple participants with breast cancer or melanoma, it may be possible to identify how a person's gut health and tumor microenvironment affects how they respond to certain cancer treatments.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Contact us for the latest status
View complete study & contact information

Print study details
Site IRB:
Jacksonville, Florida: 24-003806

NCT ID:
NCT06126003

Sponsor Protocol Number:
BIOMAP-201

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Search Results 1-4 of 4 for checkpoint inhibitor, cancer

Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis

Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

A Study to Evaluate the Safety, Tolerability, and Determine the Optimal Dose for the Expansion Cohorts of VSV-IFNβ-NIS in Combination with Pembrolizumab in Patients with Refractory Solid Tumors

Gut and Tumor Microbiome in Patients With Advanced ER-positive and HER2-negative Breast Cancer or Advanced Melanoma Undergoing PD-1 Checkpoint Inhibitor Therapy.

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