← Back to Search

Other

BMS-986340 + Nivolumab/Docetaxel 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
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months, 12 months
Awards & highlights

Study Summary

This trial is testing a new drug, BMS-986340, to see if it is safe and works well against advanced solid tumors when used alone or with another drug, nivolumab.

Who is the study for?
This trial is for adults with advanced solid tumors who've tried, can't tolerate, or have no other treatment options. They must have measurable disease and provide tumor biopsies for analysis. Not eligible if they had recent major surgery, are pregnant/breastfeeding, have certain lung diseases or autoimmune conditions, untreated brain metastases, or need steroids/immunosuppressants.Check my eligibility
What is being tested?
The study tests BMS-986340 alone and combined with Nivolumab (BMS-936558-01) or Docetaxel in patients with various advanced cancers to find safe doses and see how well they work. It's the first time BMS-986340 is being given to humans in this setting.See study design
What are the potential side effects?
Potential side effects may include typical reactions from cancer therapies such as fatigue, nausea, allergic responses to the drugs administered during infusion sessions; organ-specific inflammation; blood cell count changes; 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 a tumor that can be measured and biopsied, not just with a fine needle or from bone.
Select...
My cancer has worsened after my last treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months, 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 AEs leading to death
Incidence of AEs leading to discontinuation
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
+2 more
Secondary outcome measures
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy
+16 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 2B: BMS-986340 + Nivolumab Dose ExpansionExperimental Treatment2 Interventions
Group II: Part 2A: BMS-986340 Dose ExpansionExperimental Treatment1 Intervention
Group III: Part 1C: BMS-986340 + Docetaxel Dose EscalationExperimental Treatment2 Interventions
Group IV: Part 1B: BMS-986340 + Nivolumab Dose EscalationExperimental Treatment2 Interventions
Group V: Part 1A: BMS-986340 Dose EscalationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,646 Previous Clinical Trials
4,130,498 Total Patients Enrolled

Media Library

BMS-936558-01 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04895709 — Phase 1 & 2
BMS-936558-01 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04895709 — Phase 1 & 2
Squamous Cell Carcinoma Research Study Groups: Part 1C: BMS-986340 + Docetaxel Dose Escalation, Part 2B: BMS-986340 + Nivolumab Dose Expansion, Part 2A: BMS-986340 Dose Expansion, Part 1B: BMS-986340 + Nivolumab Dose Escalation, Part 1A: BMS-986340 Dose Escalation
Squamous Cell Carcinoma Clinical Trial 2023: BMS-936558-01 Highlights & Side Effects. Trial Name: NCT04895709 — Phase 1 & 2

Frequently Asked Questions

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

What therapeutic purpose does BMS-986340 usually fulfill?

"BMS-986340 is a common treatment for malignant neoplasms, such as unresectable melanoma and squamous cell carcinoma. It can also be used to manage metastatic esophageal adenocarcinoma."

Answered by AI

Are there any precedents of research into BMS-986340?

"Since its inception at Local Institution in 2012, BMS-986340 has been tested via 250 completed clinical trials. Presently there are 718 active studies being conducted around the world with a significant portion centered in Edmonton, Oregon."

Answered by AI

What is the current population of participants in this experiment?

"This trial, sponsored by Bristol-Myers Squibb, requires 185 patients who meet its enrollment criteria. The experiment will be carried out at Local Institution in Edmonton, Oregon and Columbia University Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical Protocol in Portland, Quebec."

Answered by AI

At what locations can patients access this clinical trial?

"This clinical trial is actively recruiting patients from 15 different centres. Examples of these include Local Institution in Edmonton, Columbia University Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical Protocol in Portland, and Memorial Sloan Kettering Nassau in Montréal."

Answered by AI

Has this trial of treatment ever been conducted before?

"BMS-986340 has been under research since 2012 when Ono Pharmaceutical Co. Ltd. initiated a clinical trial involving 659 participants. After passing Phase 1 & 2, 718 studies concerning the drug have become active across 49 nations and 2356 cities worldwide."

Answered by AI

Are there any current opportunities to join this experiment?

"Affirmative. Data hosted on clinicaltrials.gov attests to this medical study's active recruitment, which commenced on May 27th 2021 and is still ongoing as of September 28th 2022. The trial requires 185 participants that will be recruited from 15 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
What site did they apply to?
Local Institution
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
2021. "A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04895709.
All > Colorectal Cancer Ventura > Renal Cell Carcinoma
~145 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