← Back to Search

Other

BMS-986340 + Nivolumab/Docetaxel for Advanced Solid Tumors

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
Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upat 6 months, 12 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Squamous Cell Carcinoma
  • Pancreatic Adenocarcinoma
  • Oral Squamous Cell Carcinoma
  • Melanoma
  • Bladder Cancer
  • Breast Cancer
  • Renal Cell Carcinoma
  • Cervical Cancer
  • Gastric Cancer
  • Colorectal Cancer
  • Ovarian Tumors

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You need to provide a tumor sample before and during treatment for testing.
Select...
You are able to carry out all regular activities without any restrictions (0) or you are restricted in physically strenuous activity but can perform light work or office work (1).
Select...
You have a tumor that can be measured and a tumor that can be biopsied, but certain types of biopsies are not allowed.
Select...
The latest treatment didn't stop the disease from getting worse, as shown in imaging tests.
Select...
You have already received the usual treatments for your condition, except for a specific type of treatment called docetaxel for advanced cancer.
Select...
You have advanced or spreading disease and have already tried treatments that are known to work for your condition.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,602 Previous Clinical Trials
4,047,586 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
Non-Small Cell Lung Cancer Research Study Groups: Part 1C: BMS-986340 + Docetaxel Dose Escalation, Part 2A: BMS-986340 Dose Expansion, Part 1B: BMS-986340 + Nivolumab Dose Escalation, Part 2B: BMS-986340 + Nivolumab Dose Expansion, Part 1A: BMS-986340 Dose Escalation
Non-Small Cell Lung Cancer 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 carcinomae 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, 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
~231 spots leftby Apr 2025