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BMS-986408 + Immunotherapy 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
Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 50 months
Awards & highlights
Study Summary
This trial is testing the safety of a new drug, BMS-986408, given alone or with other drugs, to see what the maximum tolerated dose is. The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.
Who is the study for?
This trial is for adults with advanced solid tumors that can't be surgically removed or have spread, and who haven't responded to or can't receive standard treatments. Melanoma patients must know their BRAF and NRAS mutation status. People taking steroids or other immune-suppressing drugs recently, those with certain gastrointestinal conditions, or untreated brain metastases cannot join.Check my eligibility
What is being tested?
The study is testing the safety of a new drug called BMS-986408 alone and in combination with Nivolumab, as well as together with both Nivolumab and Ipilimumab. It aims to find the highest dose patients can take without serious side effects (MTD) and the best dose for future studies (RP2D).See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system since Nivolumab and Ipilimumab are immunotherapies that may cause inflammation in various organs. The specific side effects of BMS-986408 are being studied but could also involve similar immune-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma has been tested for BRAF and NRAS mutations.
Select...
My cancer is advanced, cannot be surgically removed, and can be measured for treatment response.
Select...
My cancer has grown or spread on scans after my last treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 50 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 50 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of deaths
Number of participants with Adverse Events (AEs)
Number of participants with Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC (0-T))
Duration of Response (DOR) assessed by RECIST v1.1
Maximum concentration (Cmax)
+2 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Part 3: BMS-986408 in combination with nivolumab and chemotherapyExperimental Treatment3 Interventions
Group II: Part 3: BMS-986408 in combination with nivolumabExperimental Treatment2 Interventions
Group III: Part 2: BMS-986408 in combination with rabeprazoleExperimental Treatment2 Interventions
Group IV: Part 2: BMS-986408 in combination with nivolumab and ipilimumabExperimental Treatment3 Interventions
Group V: Part 2: BMS-986408 in combination with nivolumab and chemotherapyExperimental Treatment3 Interventions
Group VI: Part 2: BMS-986408 in combination with nivolumabExperimental Treatment2 Interventions
Group VII: Part 1: BMS-986408 MonotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rabeprazole
2017
Completed Phase 4
~3920
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2610
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,130,430 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My melanoma has been tested for BRAF and NRAS mutations.I haven't taken steroids or immunosuppressants in the last 30 days.I've tried or can't take standard treatments for my condition.I have had recent stomach or intestine problems or surgery that could affect how I absorb medication.I have brain metastases that have not been treated.My cancer is advanced, cannot be surgically removed, and can be measured for treatment response.My cancer has grown or spread on scans after my last treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: BMS-986408 in combination with rabeprazole
- Group 2: Part 3: BMS-986408 in combination with nivolumab
- Group 3: Part 3: BMS-986408 in combination with nivolumab and chemotherapy
- Group 4: Part 2: BMS-986408 in combination with nivolumab and chemotherapy
- Group 5: Part 1: BMS-986408 Monotherapy
- Group 6: Part 2: BMS-986408 in combination with nivolumab
- Group 7: Part 2: BMS-986408 in combination with nivolumab and ipilimumab
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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