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Immunotherapy

BMS-986288 + Nivolumab for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?
This trial is for adults with certain advanced solid tumors that have grown or returned after standard treatment. Participants must be fairly active and healthy otherwise (good performance status), and have at least one tumor that can be biopsied.Check my eligibility
What is being tested?
The study is testing BMS-986288, an investigational immunotherapy, alone and in combination with Nivolumab to see if they are safe and effective for treating advanced cancers.See study design
What are the potential side effects?
Potential side effects may include typical reactions to immunotherapies such as fatigue, skin reactions, inflammation of organs like the lungs or intestines, flu-like symptoms, and changes in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has spread, can't be removed by surgery, and has a tumor that can be biopsied.
Select...
I am fully active or can carry out light work.
Select...
My cancer returned or worsened after 1 standard treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review
Secondary outcome measures
Accumulation Index (AI) of BMS-986288
Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288
Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288
+19 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2C: BMS-986288 in combination with Nivolumab and RegorafenibExperimental Treatment3 Interventions
Group II: Arm B: BMS-986288 in combination with NivolumabExperimental Treatment2 Interventions
Group III: Arm A: BMS-986288 MonotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Regorafenib
2014
Completed Phase 2
~1580

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,006 Total Patients Enrolled

Media Library

BMS-986288 (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03994601 — Phase 1 & 2
Cancer Clinical Trial 2023: BMS-986288 Highlights & Side Effects. Trial Name: NCT03994601 — Phase 1 & 2
BMS-986288 (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03994601 — Phase 1 & 2
Cancer Research Study Groups: Arm A: BMS-986288 Monotherapy, Arm B: BMS-986288 in combination with Nivolumab, Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib

Frequently Asked Questions

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

What is the current enrollment rate for this trial?

"To carry out the trial, Bristol-Myers Squibb needs to recruit 344 eligible individuals. These participants will be coming from Local Institution - 0006 in Saint Louis and Washington University located in Hackensack."

Answered by AI

Is this research unprecedented in its scope and methodology?

"Since 2012, the development of BMS-986288 has been rigorous and far reaching. Initially sponsored by Ono Pharmaceutical Co. Ltd., its initial trial attracted 659 participants in 2012; this led to Phase 1 & 2 approval from governing bodies. Nowadays, there are 718 studies across 2356 cities spread out over 49 nations tracking outcomes for BMS-986288."

Answered by AI

Are there any opportunities for participation in this research trial?

"The documentation on clinicaltrials.gov verifies that recruitment for this trial is still open, having been first published on the 6th of September 2019 and last modified during October 19th 2022."

Answered by AI

In what areas can participants access this clinical trial?

"This medical trial is being run in multiple different locations, including Local Institution - 0006 in Saint Louis, Missouri, Washington University in Hackensack, New jersey and the Hackensack University Medical Center of Baltimore, Maryland."

Answered by AI

Has the efficacy of BMS-986288 been previously assessed in any other clinical trials?

"BMS-986288 was initially investigated in 2012 at a nearby medical facility. Since then, there have been 252 trials completed and 718 ongoing tests around the world. Most of these are happening in Saint Louis, Missouri."

Answered by AI

What ailments is BMS-986288 typically prescribed to treat?

"BMS-986288 is regularly prescribed for the management of malignant neoplasms. Additionally, it has been shown to be efficacious in cases where patients have unresectable melanoma, squamous cell carcinoma, or metastatic esophageal adenocarcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
2019. "An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03994601.
~88 spots leftby Apr 2025
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