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BMS-986253 + Immunotherapy for Advanced Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
Must not have
Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years

Summary

This trial is testing a new drug called BMS-986253 along with other cancer treatments, Nivolumab and Ipilimumab, in patients with advanced cancers to see if it can improve their effectiveness.

Who is the study for?
This trial is for adults with advanced solid tumors, who are physically capable of daily activity or light work. They must have a tumor that can be measured and one that's reachable for biopsy. People taking high-dose steroids, recent cytotoxic agents, those with HIV/AIDS, or active autoimmune diseases cannot join.
What is being tested?
The study tests BMS-986253 in combination with Nivolumab or both Nivolumab and Ipilimumab against cancer. Participants will receive either the experimental medication plus standard treatments or a placebo alongside standard treatments to compare effectiveness.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms like chills and fever, fatigue, skin issues from rash to itching, gastrointestinal problems such as diarrhea or colitis, liver inflammation and potential hormonal gland issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
Select...
My cancer has spread, cannot be surgically removed, and can be measured by scans.
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I have a tumor that can be biopsied.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
It's been over 4 weeks since my last cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria
Incidence of adverse events (AE)
Incidence of deaths
+2 more
Secondary study objectives
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Serum
Duration of response (DOR) per response evaluation criteria in solid tumors (RECIST) v1.1 per investigator
+15 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2A: BMS-986253 + nivolumab + ipilimumabExperimental Treatment3 Interventions
Group II: Part 1C: BMS-986253 + nivolumab + ipilimumabExperimental Treatment3 Interventions
Group III: Part 1B: BMS-986253 + nivolumabExperimental Treatment2 Interventions
Group IV: Part 1A: BMS-986253 + nivolumabExperimental Treatment2 Interventions
Group V: Part 2B: Placebo + nivolumab + ipilimumabPlacebo Group3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986253
2020
Completed Phase 2
~50
Ipilimumab
2015
Completed Phase 3
~3420
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,691 Previous Clinical Trials
4,097,307 Total Patients Enrolled

Media Library

BMS-986253 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03400332 — Phase 1 & 2
Cancer Research Study Groups: Part 2A: BMS-986253 + nivolumab + ipilimumab, Part 2B: Placebo + nivolumab + ipilimumab, Part 1A: BMS-986253 + nivolumab, Part 1B: BMS-986253 + nivolumab, Part 1C: BMS-986253 + nivolumab + ipilimumab
Cancer Clinical Trial 2023: BMS-986253 Highlights & Side Effects. Trial Name: NCT03400332 — Phase 1 & 2
BMS-986253 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03400332 — Phase 1 & 2
~36 spots leftby Dec 2025
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