← Back to Search

Other

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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I have had one platinum-based chemotherapy for endometrial cancer.
Select...
I am fully active or can carry out light work.
Select...
My condition is recurrent or persistent endometrial cancer or carcinosarcoma.
Select...
I am fully active or can carry out light work.
Select...
I have had up to three treatments for my recurring cancer.
Select...
I am a woman over 18 with an expected lifespan of at least 12 weeks.
Select...
I have a confirmed diagnosis of recurrent or persistent endometrial cancer.
Select...
I have had one platinum-based chemotherapy for endometrial cancer or carcinosarcoma.
Select...
I have at least one tumor that can be measured with scans or exams.
Select...
I am not able to become pregnant or I have a negative pregnancy test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response

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
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,786 Total Patients Enrolled
2 Trials studying Endometrial Carcinosarcoma
105 Patients Enrolled for Endometrial Carcinosarcoma
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,476 Total Patients Enrolled
Chrisann Kyi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Nivolumab (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04106414 — Phase 2
Endometrial Carcinosarcoma Research Study Groups: Nivolumab alone, Nivolumab with IDO-inhibitor, BMS- 986205
Endometrial Carcinosarcoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04106414 — Phase 2
Nivolumab (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04106414 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographic scope of this clinical investigation?

"This clinical trial is offered in 7 distinct locations, such as Memorial Sloan Kettering Basking Ridge in Basking Ridge, Middletown's Memorial Sloan Kettering Monmouth, and the renowned Memorial Sloan Kettering Cancer Center located in New york."

Answered by AI

Are there vacant slots to join this experiment?

"According to clinicaltrials.gov, the recruitment period for this medical trial has closed; it was initially announced on September 24th 2019 and last updated November 29th 2022. Although no longer actively recruiting patients, there are still a plethora of other trials searching for participants."

Answered by AI

What is the capacity of this research project?

"At this moment, the trial is not recruiting any new patients. The study was first published on September 24th 2019 and last updated on November 29th 2022. However, if you are seeking alternative trials, there are currently 309 clinical studies for endometrial neoplasms and 718 Nivolumab-related experiments that require participants."

Answered by AI

Does this medical trial represent a pioneering approach to healthcare?

"Nivolumab is part of 718 active trials across 2354 cities and 49 nations. The initial evaluation was conducted by Ono Pharmaceutical Co. Ltd in 2012, with 659 participants taking part in Phase 1 & 2 testing. After this pioneering research concluded, subsequent 259 studies have been completed up to now."

Answered by AI

To what extent is Nivolumab utilized to treat medical conditions?

"Nivolumab is a commonly prescribed drug for treating malignancy. It can also be used to address unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinomas."

Answered by AI

Has the Nivolumab drug been authorized by the Food and Drug Administration?

"Considering the fact that Nivolumab is still in its Phase 2 clinical trials, where there has only been some evidence of safety but none of efficacy, our team at Power assigned it a score of 2."

Answered by AI

What other exploratory studies have been conducted with regard to Nivolumab?

"At present, there are 718 research studies dedicated to Nivolumab's efficacy. Of those experiments, 82 have progressed to Phase 3 and can be found in 40237 sites across the globe with a majority of them located in Basel, BE."

Answered by AI
~2 spots leftby Sep 2024