BMS-986315 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Solid Tumors, Advanced Solid Tumors+1 More
BMS-986315 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug, BMS-986315, to see if it works alone or in combination with other drugs to treat advanced solid tumors.

Eligible Conditions
  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

5 Primary · 22 Secondary · Reporting Duration: Up to 12 months

Up to 119 weeks
Incidence of adverse events (AEs)
Incidence of adverse events (AEs) leading to discontinuation
Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria
Incidence of anti-drug antibodies to BMS-986315
Incidence of anti-drug antibodies to BMS-986315 with cetuximab
Incidence of anti-drug antibodies to BMS-986315 with nivolumab
Incidence of serious adverse events (SAEs)
Number of deaths
Trough observed serum concentrations (Ctrough) of BMS-986315
Up to 12 months
Duration of Response (DOR)
Objective Response Rate (ORR)
Progression-Free Survival Rate (PFSR)
Up to 16 weeks
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with cetuximab
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with nivolumab
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with cetuximab
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with nivolumab
Maximum observed serum concentration (Cmax) of BMS-986315
Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab
Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab
Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315
Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab
Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab
Time of maximum observed serum concentration (Tmax) of BMS-986315
Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab
Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Trial Design

3 Treatment Groups

BMS-986315 + cetuximab
1 of 3
BMS-986315 + nivolumab
1 of 3
BMS-986315
1 of 3
Experimental Treatment

308 Total Participants · 3 Treatment Groups

Primary Treatment: BMS-986315 · No Placebo Group · Phase 1 & 2

BMS-986315 + cetuximabExperimental Group · 2 Interventions: BMS-986315, cetuximab · Intervention Types: Biological, Biological
BMS-986315 + nivolumabExperimental Group · 2 Interventions: BMS-986315, nivolumab · Intervention Types: Biological, Biological
BMS-986315
Biological
Experimental Group · 1 Intervention: BMS-986315 · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Cetuximab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,481 Previous Clinical Trials
3,919,564 Total Patients Enrolled
20 Trials studying Solid Tumors, Advanced Solid Tumors
6,210 Patients Enrolled for Solid Tumors, Advanced Solid Tumors

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Participants expected to have received the same standard of care therapies as other people with cancer, including an available PD-(L)1 inhibitor if their Eastern cooperative oncology group performance status was 0 or 1.
People with advanced squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), or renal cell cancer (RCC) that has spread (metastasized) and cannot be surgically removed, are eligible to participate in this study

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: October 17th, 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.