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BMS-986416 + Nivolumab for Solid Tumors

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
Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
Disease amenable to serial biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new drug, BMS-986416, to see if it is safe and effective when used alone or with another drug, nivolumab, to treat advanced solid tumors.

Who is the study for?
This trial is for adults with certain advanced solid tumors like lung, bladder, head and neck, liver, colorectal cancer or pancreatic cancer. They must have measurable disease that's resistant to standard treatments and be able to undergo biopsies. People can't join if they have serious heart issues, need blood thinners (except low-dose aspirin), or have specific connective tissue diseases.Check my eligibility
What is being tested?
The study is testing BMS-986416 alone and combined with Nivolumab in patients with select solid tumors. It aims to assess the safety of these drugs, how well they're tolerated by the body, their effects on the tumor size and drug levels in the bloodstream.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, fatigue, nausea, immune-related conditions where the body attacks its own cells or organs (like colitis or hepatitis), skin rash and potential complications from biopsies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is advanced, cannot be surgically removed, has spread, or come back.
Select...
My condition allows for repeated tissue sampling.
Select...
My cancer type is one of the specified: NSCLC, UC, SCCHN, HCC, MSS CRC, or PDAC.
Select...
My condition hasn't improved with standard treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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 death
Incidence of AEs leading to discontinuation
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
+3 more
Secondary outcome measures
Duration of Response (DOR) using RECIST 1.1 per Investigator assessment
Incidence of clinically significant changes in ECG parameters: QTcF
Maximum observed serum concentration (Cmax) of BMS-986416
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 1B: Combination Therapy (BMS-986416 + Nivolumab)Experimental Treatment2 Interventions
Group II: Part 1A: Monotherapy (BMS-986416)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,380 Total Patients Enrolled

Media Library

BMS-986416 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04943900 — Phase 1
Solid Tumors Research Study Groups: Part 1A: Monotherapy (BMS-986416), Part 1B: Combination Therapy (BMS-986416 + Nivolumab)
Solid Tumors Clinical Trial 2023: BMS-986416 Highlights & Side Effects. Trial Name: NCT04943900 — Phase 1
BMS-986416 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04943900 — Phase 1

Frequently Asked Questions

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

What indications have warranted the administration of BMS-986416?

"BMS-986416 is generally prescribed to address malignant tumors, but it can also be employed as a therapeutic approach for additional medical conditions such as metastatic esophageal adenocarcinoma and unresectable melanoma."

Answered by AI

Is this a previously unexplored research endeavor?

"As of today, Ono Pharmaceutical Co. Ltd's BMS-986416 has 717 live trials being conducted in 2356 cities and 49 nations. Starting back in 2012 with 659 participants who went through Phase 1 & 2 approval stages, 252 additional studies have since been successfully completed."

Answered by AI

How many participants is the research team recruiting for this clinical trial?

"Indeed, clinicaltrials.gov confirms that this study is presently enrolling 134 individuals from 20 different medical centres. The trial was initially posted on August 9th 2021 and the most recent update was November 28th 2022."

Answered by AI

What prior research has been done concerning BMS-986416?

"Presently, there are 82 BMS-986416 trials in phase 3 and 717 studies ongoing. Basel, BE is the primary site for many of these tests; however, 40290 locations worldwide have clinical trials studying this medication."

Answered by AI

What is the geographical scope of this clinical experiment?

"The experiment is currently enrolling patients from 20 different sites, including Madison, Toronto and Aurora. To reduce the burden of travel for participants it is advised to select a location that is proximate."

Answered by AI

Has the FDA sanctioned BMS-986416 as a therapeutic course of action?

"The safety of BMS-986416 is assessed to be a 1 due its standing as a Phase 1 trial, thus providing limited evidence for both efficacy and safety."

Answered by AI

Does this clinical trial currently have openings for participants?

"As confirmed by clinicaltrials.gov, this trial is still welcoming participants since it was initially listed on August 9th 2021 and updated November 28th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Local Institution
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
2021. "A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04943900.
~65 spots leftby Dec 2026
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