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BMS-986249 + Nivolumab for 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?
This trial is for adults with advanced solid tumors who've had at least one standard treatment fail. They should be able to follow the study plan and have a tumor that can be biopsied. People with autoimmune diseases, brain metastases as their only cancer site, or those needing treatment for another active cancer aren't eligible.Check my eligibility
What is being tested?
The study tests BMS-986249 alone and combined with Nivolumab in treating advanced solid tumors. It aims to find out if these treatments are safe and how well patients tolerate them.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, skin issues, digestive problems, hormonal changes, and increased infection risk due to immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 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 leading to discontinuation
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Incidence of Adverse Events (AEs)
+5 more
Secondary outcome measures
AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration)
Cmax (Maximum observed serum concentration)
Duration of response (DOR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)
+10 more

Trial Design

11Treatment groups
Experimental Treatment
Group I: Part 2B Cohort 3: BMS-986249 + nivoExperimental Treatment2 Interventions
Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
Group II: Part 2B Cohort 2: BMS-986249 + nivoExperimental Treatment2 Interventions
Metastatic castration-resistant prostate cancer (CRPC)
Group III: Part 2B Cohort 1: BMS-986249 + nivoExperimental Treatment2 Interventions
Advanced or intermediate hepatocellular carcinoma (HCC)
Group IV: Part 2A Arm F: BMS-986249 + nivoExperimental Treatment2 Interventions
Previously untreated unresectable stage III-IV melanoma
Group V: Part 2A Arm E: NivoExperimental Treatment1 Intervention
Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm
Group VI: Part 2A Arm D: ipilimumab + nivo then nivoExperimental Treatment2 Interventions
Previously untreated unresectable stage III-IV melanoma
Group VII: Part 2A Arm C: BMS-986249 + nivoExperimental Treatment2 Interventions
Previously untreated unresectable stage III-IV melanoma
Group VIII: Part 2A Arm B: BMS-986249 + nivoExperimental Treatment2 Interventions
Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm
Group IX: Part 2A Arm A: BMS-986249 + nivo then nivoExperimental Treatment2 Interventions
Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm
Group X: Part 1B: BMS-986249 + nivolumab (nivo)Experimental Treatment2 Interventions
Group XI: Part 1A: BMS-986249Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,089 Total Patients Enrolled

Media Library

BMS-986249 Clinical Trial Eligibility Overview. Trial Name: NCT03369223 — Phase 1 & 2
Cancer Research Study Groups: Part 1A: BMS-986249, Part 1B: BMS-986249 + nivolumab (nivo), Part 2A Arm C: BMS-986249 + nivo, Part 2A Arm D: ipilimumab + nivo then nivo, Part 2A Arm F: BMS-986249 + nivo, Part 2B Cohort 1: BMS-986249 + nivo, Part 2B Cohort 3: BMS-986249 + nivo, Part 2A Arm A: BMS-986249 + nivo then nivo, Part 2A Arm B: BMS-986249 + nivo, Part 2A Arm E: Nivo, Part 2B Cohort 2: BMS-986249 + nivo
Cancer Clinical Trial 2023: BMS-986249 Highlights & Side Effects. Trial Name: NCT03369223 — Phase 1 & 2
BMS-986249 2023 Treatment Timeline for Medical Study. Trial Name: NCT03369223 — 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 has BMS-986249 been found to be efficacious in treating various medical conditions?

"BMS-986249 is a viable therapeutic option for individuals who have had anti-angiogenic therapy, malignant tumours, and unresectable melanomas."

Answered by AI

Are there any vacancies remaining for this clinical investigation?

"As indicated by clinicaltrials.gov, subject recruitment for this trial is still underway. It was initially published on December 6th 2017 and the most recent edits were made on April 30 2022."

Answered by AI

In what regions are participants able to access this clinical trial?

"This trial is available in 20 sites, which include Tyler, Baltimore and Leesburg as well as other nearby locations. It might be beneficial to choose the closest site for participants to reduce travel time commitments."

Answered by AI

Could you elaborate on the other research projects involving BMS-986249?

"The first BMS-986249 trials were conducted at Texas Children's Hospital in 2009. Since then, 365 clinical studies have been completed and 765 are active. Notably, Tyler, Texas has become a hub for this drug with many ongoing tests being held there."

Answered by AI

How many individuals have been recruited to participate in this clinical research?

"This medical trial necessitates the enrolment of 425 eligible patients. The sponsor, Bristol-Myers Squibb will manage this endeavour from various sites, such as Texas Oncology, P.A. in Tyler andTexas Oncology - DFWW Baltimore Maryland."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
2017. "A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03369223.
~21 spots leftby Sep 2024
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