Part 1: BMS-986408 Monotherapy for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ
Cancer+1 More
BMS-986408 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

Eligible Conditions

  • Cancer
  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Up to 50 months

Up to 27 months
Area under the concentration-time curve from time 0 to time of last quantifiable concentration (AUC (0-T))
Maximum concentration (Cmax)
Time of maximum observed concentration (Tmax)
Up to 28 days
Number of participants with Dose-Limiting Toxicities (DLTs)
Up to 29 months
Number of participants with Adverse Events (AEs)
Up to 50 months
Duration of Response (DOR) assessed by RECIST v1.1
Number of deaths
Objective Response Rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Trial Safety

Trial Design

3 Treatment Groups

Part 1: BMS-986408 Monotherapy
1 of 3
Part 2: BMS-986408 in combination with nivolumab
1 of 3
Part 2: BMS-986408 in combination with nivolumab and ipilimumab
1 of 3
Experimental Treatment

113 Total Participants · 3 Treatment Groups

Primary Treatment: Part 1: BMS-986408 Monotherapy · No Placebo Group · Phase 1 & 2

Part 1: BMS-986408 Monotherapy
Drug
Experimental Group · 1 Intervention: BMS-986408 · Intervention Types: Drug
Part 2: BMS-986408 in combination with nivolumabExperimental Group · 2 Interventions: BMS-986408, Nivolumab · Intervention Types: Drug, Biological
Part 2: BMS-986408 in combination with nivolumab and ipilimumabExperimental Group · 3 Interventions: BMS-986408, Nivolumab, Ipilimumab · Intervention Types: Drug, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5540
Ipilimumab
2014
Completed Phase 3
~3350

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 50 months
Closest Location: John Theurer Cancer Center at Hackensack University Medical Center · Hackensack, NJ
Photo of Hackensack  1Photo of Hackensack  2Photo of Hackensack  3
2017First Recorded Clinical Trial
0 TrialsResearching Cancer
48 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.
You have experienced radiographically documented progressive disease on or after the most recent therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.