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Nivolumab + BMS-986205 for Endometrial Cancer
Phase 2
Waitlist Available
Led By Chrisann Kyi, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
One prior platinum-based chemotherapeutic regimen for endometrial carcinoma or carcinosarcoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Must not have
Uncontrolled seizures
History and/or confirmed pneumonitis or interstitial lung disease requiring steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effects of the immunotherapy drug nivolumab, with or without the experimental drug BMS-986205. The addition of BMS-986205 to nivolumab may improve treatment results, but may also cause side effects.
Who is the study for?
This trial is for women over 18 with certain types of persistent or recurrent endometrial cancer, including carcinosarcoma. They must have had one prior platinum-based chemotherapy and can't be pregnant or breastfeeding. Participants need measurable disease by specific criteria, adequate organ function, and a life expectancy of at least 12 weeks.
What is being tested?
The study compares the effects of nivolumab alone to nivolumab combined with an experimental drug called BMS-986205 in treating endometrial cancer that hasn't responded to previous treatments. The goal is to see if adding BMS-986205 improves outcomes.
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, digestive issues like diarrhea or constipation, skin problems such as rash or itching, hormonal imbalances and possible increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had one platinum-based chemotherapy for endometrial cancer.
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I am fully active or can carry out light work.
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My condition is recurrent or persistent endometrial cancer or carcinosarcoma.
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I am fully active or can carry out light work.
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I have had up to three treatments for my recurring cancer.
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I am a woman over 18 with an expected lifespan of at least 12 weeks.
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I have a confirmed diagnosis of recurrent or persistent endometrial cancer.
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I have had one platinum-based chemotherapy for endometrial cancer or carcinosarcoma.
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I have at least one tumor that can be measured with scans or exams.
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I am not able to become pregnant or I have a negative pregnancy test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I experience seizures that my medication cannot control.
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I have had pneumonitis or lung disease treated with steroids.
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I had major surgery less than 4 weeks ago.
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I have not received a live vaccine in the last 30 days.
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I have been treated with specific immune therapy drugs before.
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I have fluid buildup in my abdomen that treatments haven't helped.
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I have brain metastases that need treatment.
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I have a G6PD deficiency and high methemoglobin levels in my blood.
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I have had cancer spread to the lining of my brain and spinal cord.
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I do not have any unmanaged ongoing illnesses.
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My cancer is known to have mismatch repair deficiency.
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I have or had inflammatory bowel disease.
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I have been diagnosed with tuberculosis in the past.
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I had a severe reaction to previous immune therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Nivolumab with IDO-inhibitor, BMS- 986205Experimental Treatment2 Interventions
Nivolumab 480 mg every 4 weeks with BMS-986205 100 mg.
Group II: Nivolumab aloneExperimental Treatment1 Intervention
Nivolumab 480 mg every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,411 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,523 Total Patients Enrolled
Chrisann Kyi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience seizures that my medication cannot control.I have had one platinum-based chemotherapy for endometrial cancer.I am fully active or can carry out light work.You have received an organ transplant from another person in the past.My condition is recurrent or persistent endometrial cancer or carcinosarcoma.I am fully active or can carry out light work.I have had up to three treatments for my recurring cancer.I have had another type of cancer before.I had major surgery less than 4 weeks ago.I have not received a live vaccine in the last 30 days.I can provide previous biopsy samples or am willing to have a new biopsy.I am a woman over 18 with an expected lifespan of at least 12 weeks.I am a woman over 18 with an expected lifespan of 3 months or more.I have had up to 3 chemotherapy treatments for my recurring cancer. Hormone treatments don’t count.I have been treated with specific immune therapy drugs before.I haven't taken cancer drugs in the last 21 days or hormone therapy in the last 7 days.I have fluid buildup in my abdomen that treatments haven't helped.I have had pneumonitis or lung disease treated with steroids.My side effects from recent cancer treatments are mild, except for hair loss or nerve issues.I have had an autoimmune disease in the last 2 years.I have brain metastases that need treatment.I have at least one tumor that can be measured with scans or exams.You have enough infection-fighting white blood cells, called neutrophils, in your body.I have a G6PD deficiency and high methemoglobin levels in my blood.I have had cancer spread to the lining of my brain and spinal cord.I or my family have a history of conditions that could lead to high methemoglobin levels.I do not have any unmanaged ongoing illnesses.You need to have a certain number of platelets in your blood, which is 75 x 10^9/L or more.You have a medical condition that makes it difficult to evaluate the study treatment or interpret the results.My cancer is known to have mismatch repair deficiency.I have a confirmed diagnosis of recurrent or persistent endometrial cancer.I have or had inflammatory bowel disease.My organs and bone marrow are functioning well.I have had one platinum-based chemotherapy for endometrial cancer or carcinosarcoma.I have been diagnosed with tuberculosis in the past.My side effects from recent treatments are mild or gone.I have at least one measurable tumor that can be tracked for treatment response.I am not able to become pregnant or I have a negative pregnancy test.I haven't taken immunosuppressive drugs in the last 28 days, with some exceptions.I had a severe reaction to previous immune therapy.I have a condition that affects how my body absorbs pills.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab alone
- Group 2: Nivolumab with IDO-inhibitor, BMS- 986205
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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