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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

Study Summary

This trial is testing a new medication, BMS-986253, in combination with other drugs, to see if it can help treat advanced cancers.

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.Check my eligibility

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.See study design

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.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

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

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

Primary outcome measures

Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria

Incidence of adverse events (AE)

Incidence of deaths

+1 more

Secondary outcome measures

Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

Serum

Incidence of AEs

+16 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

Ipilimumab

2014

Completed Phase 3

~2620

Nivolumab

2014

Completed Phase 3

~4750

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,128 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

Frequently Asked Questions

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

How is BMS-986253 typically employed in medical practice?

"BMS-986253 is frequently used to counteract the effects of anti-angiogenic therapy. It has also been proven effective in treating a range of malignancies, from unresectable melanoma to squamous cell carcinoma."

Answered by AI

What other investigations have been conducted with regards to BMS-986253?

"BMS-986253 was researched for the first time in 2009 at Texas Children's Hospital. To date, 18672 trials have been completed and 765 are actively recruiting individuals to participate. Notably, a substantial number of these studies can be found around Montréal, Georgia."

Answered by AI

How many individuals have enrolled in this trial?

"To ensure the success of this research, a total of 372 participants that meet all inclusion criteria must be recruited. Potential recruits can find locations in Montréal, Georgia and Marietta, California."

Answered by AI

Are there any vacancies for participants in this medical experiment?

"The details of the trial, which were first made public on February 12th 2018 and updated on November 28th 2022, are still available for potential participants to view via clinicialtrials.gov."

Answered by AI

What expectations has this trial set for its results?

"This long-term trial, which is expected to last approximately 5 years, aims to measure the primary outcome of adverse events meeting pre-determined dose limiting toxicities (DLT) criteria. Secondary objectives include progression free survival hazard ratio based on Blinded Independent Central Review (BICR) assessments per Response Evaluation Criteria in Solid Tumours v1.1 as well as incidence of death and clinically significant changes in clinical laboratory results from urinalysis tests."

Answered by AI

How many facilities within the state are running this research effort?

"This experimental trial is conducted out of Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies in Montréal, Georgia, Local Institution - 0056 in Marietta, California, and Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital in Los Angeles. Additionally there are 43 other clinical sites participating across the US."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

2018. "A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03400332.

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