← Back to Search

Immunotherapy

BMS-986301 + Immunotherapy for Cancer

Phase 1
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
Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until study exit (up to approximately 2 years)
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new cancer drug, BMS-986301, either alone or in combination with two other drugs. The goal is to find the best dose of BMS-986301 and to see if it can help people with cancer who haven't responded to other treatments.

Who is the study for?
This trial is for adults with certain advanced cancers (like lung, skin, kidney, breast, and bladder cancer) that haven't responded to standard treatments. Participants must be in fairly good physical shape (ECOG score of 0 or 1), have seen their cancer grow despite treatment, and agree to use birth control if necessary. People with other active cancers needing treatment or serious heart disease can't join.Check my eligibility
What is being tested?
The study is testing BMS-986301 alone or combined with Nivolumab and Ipilimumab in patients whose cancers didn't respond to therapies that boost the immune system's ability to fight cancer. It aims to find the safest dose, how well people tolerate it, any toxic effects at different doses, and the best way to give these drugs.See study design
What are the potential side effects?
Possible side effects include typical reactions from immunotherapy like fatigue, skin reactions, inflammation of organs such as intestines or lungs which might cause diarrhea or breathing difficulties respectively; also potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is advanced and has not responded to current treatments.
Select...
I am fully active or have some restrictions but can still care for myself.
Select...
My cancer has grown or spread on scans after my last treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until study exit (up to approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until study exit (up to approximately 2 years) 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 AEs leading to discontinuation
Incidence of adverse events (AEs)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
+5 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + IpilimumabExperimental Treatment3 Interventions
Group II: Part 1B Group 4: Systemic BMS-986301 + Nivolumab + IpilimumabExperimental Treatment3 Interventions
Group III: Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-studyExperimental Treatment3 Interventions
Group IV: Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-studyExperimental Treatment3 Interventions
Group V: Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)Experimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,310 Total Patients Enrolled

Media Library

BMS-986301 (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03956680 — Phase 1
Solid Tumors Research Study Groups: Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM), Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab, Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study, Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study, Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab
Solid Tumors Clinical Trial 2023: BMS-986301 Highlights & Side Effects. Trial Name: NCT03956680 — Phase 1
BMS-986301 (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03956680 — Phase 1

Frequently Asked Questions

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

To what extent is this research project including people as participants?

"The sponsor, Bristol-Myers Squibb, requires 190 patients that meet the inclusion criteria of this trial to be recruited. Washington University School Of Medicine-Siteman Cancer Center in Saint Louis and Local Institution - 0001 in Toronto are two major sites engaging with the study."

Answered by AI

Has BMS-986301 been given the regulatory go-ahead by the FDA?

"The safety of BMS-986301 is speculated to be a 1 on the scale, as this is an early phase trial with minimal data that suggests it's both effective and safe."

Answered by AI

Are researchers currently seeking participants for this trial?

"According to the information posted on clinicaltrials.gov, this medical study is actively recruiting participants as of November 1st 20212. The trial was initially launched on March 26th 2019."

Answered by AI

What medical conditions is BMS-986301 commonly prescribed for?

"BMS-986301 is a viable option for patients with previous anti-angiogenic therapy, malignant tumors, and unresectable melanoma."

Answered by AI

In what quantity are locations conducting this experiment?

"Five different sites are currently running this clinical trial, with locations in Saint Louis, Toronto and Chicago among others. For the comfort of potential participants, it is suggested that they select the site closest to them in order to reduce travel demands."

Answered by AI

What other experiments have been conducted utilizing BMS-986301?

"BMS-986301 was initially studied in 2009 at Texas Childrens Hospital, and since then 365 clinical trials have been successfully completed. Presently, there are 764 active studies taking place with a sizeable portion of these located in Saint Louis, Missouri."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers
2019. "An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03956680.
~32 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