← Back to Search

Monoclonal Antibodies

BMS-986315 + Immunotherapy for Advanced 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
Participants must have histologic confirmation of advanced squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

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.

Who is the study for?
This trial is for adults with advanced solid tumors, specifically head and neck, lung, or kidney cancer. They should be relatively healthy (good performance status) and women must use birth control. Participants should have tried standard treatments including PD-(L)1 inhibitors but can't join if they have autoimmune diseases, previous anti-NKG2A study participation, need steroids/immunosuppressants regularly, drug allergies, lung disease/fibrosis or serious heart issues.Check my eligibility
What is being tested?
The study tests BMS-986315 alone and combined with either nivolumab or cetuximab in patients with advanced solid tumors. It aims to see how well these treatments work on their own or together against different types of cancer by measuring the changes in tumor size using established criteria.See study design
What are the potential side effects?
Potential side effects include immune-related reactions due to nivolumab that could affect organs like the lungs or intestines; skin reactions from cetuximab; plus common drug side effects such as fatigue, nausea and increased risk of infections.

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.
Select...
I have advanced cancer in the head, neck, lung, or kidney with measurable disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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
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
+2 more
Secondary outcome measures
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
+19 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: BMS-986315 + nivolumabExperimental Treatment2 Interventions
Group II: BMS-986315 + cetuximabExperimental Treatment2 Interventions
Group III: BMS-986315Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~4960
cetuximab
2000
Completed Phase 3
~7290

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,192 Total Patients Enrolled

Media Library

BMS-986315 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04349267 — Phase 1 & 2
Solid Tumors Research Study Groups: BMS-986315 + nivolumab, BMS-986315 + cetuximab, BMS-986315
Solid Tumors Clinical Trial 2023: BMS-986315 Highlights & Side Effects. Trial Name: NCT04349267 — Phase 1 & 2
BMS-986315 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04349267 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial available to the public at present?

"Affirmative. Clinicaltrials.gov provides evidence that this medical research is actively seeking participants, with the initial posting being dated July 14th 2020 and edited on November 15th 2022. 308 people are required to be recruited from 11 different trial sites."

Answered by AI

How many different venues are conducting this investigation?

"Northside Hospital in Atlanta, Local Institution - 0011 in Vancouver and Local Institution - 0005 in Montreal are some of the prominent trial sites for this clinical study. Additionally, there are 11 other operating locations."

Answered by AI

To what extent has this medical trial attracted participants?

"This medical study necessitates 308 participants who meet the required criteria. These individuals can partake in this trial at Northside Hospital in Atlanta or Local Institution - 0011 located in Vancouver, British Columbia."

Answered by AI

Could you expound on the research that has been done using BMS-986315?

"BMS-986315 was initially investigated in 2007 at the Royal Bournemouth Hospital, with 618 clinical trials now finalized. Currently, 830 studies remain active and a great number of them are being conducted in Atlanta, Georgia."

Answered by AI

What is the most popular application of BMS-986315?

"BMS-986315 has been proven to be useful in treating malignant neoplasms, as well as other severe afflictions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
2020. "Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04349267.
~65 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top