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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 below

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My melanoma has been tested for BRAF and NRAS mutations.

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My cancer is advanced, cannot be surgically removed, and can be measured for treatment response.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 50 months for reporting.

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 more

Trial 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

~2670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,112 Total Patients Enrolled

Media Library

BMS-986408 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05407675 — Phase 1 & 2

Solid Tumors Research Study Groups: Part 2: BMS-986408 in combination with rabeprazole, Part 3: BMS-986408 in combination with nivolumab and chemotherapy, Part 3: BMS-986408 in combination with nivolumab, Part 2: BMS-986408 in combination with nivolumab and chemotherapy, Part 1: BMS-986408 Monotherapy, Part 2: BMS-986408 in combination with nivolumab, Part 2: BMS-986408 in combination with nivolumab and ipilimumab

Solid Tumors Clinical Trial 2023: BMS-986408 Highlights & Side Effects. Trial Name: NCT05407675 — Phase 1 & 2

BMS-986408 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05407675 — 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 many medical institutions are involved in the implementation of this clinical trial?

"This trial is recruiting patients at 9 different sites, including the John Theurer Cancer Center in Hackensack, Local Institution - 0006 in Toronto and Princess Margaret Cancer Centre in Houston."

Answered by AI

How many participants are actively enrolled in this trial?

"This clinical trial requires 113 qualified participants, and is being conducted at various sites including John Theurer Cancer Center in Hackensack, NJ, as well as Local Institution - 0006 in Toronto. Bristol-Myers Squibb are the sponsors of this research endeavour."

Answered by AI

Has enrollment for this research experiment closed yet?

"According to the clinicaltrials.gov website, this particular medical trial is currently accepting patients. The process began on August 2nd 2022 and was recently updated on October 24th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

2022. "A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05407675.