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Monoclonal Antibodies

BMS-986406 + Combination Therapies 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
Part 1D: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease
Parts 1A, 1B, 1C: Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and works well when used alone or with another existing cancer drug.

Who is the study for?
This trial is for adults with certain advanced cancers, including lung, kidney, pancreatic, and others. Participants must have a confirmed diagnosis with measurable disease and be in good physical condition. They can't join if they have untreated brain metastases, prior organ transplants or serious medical issues that aren't under control.Check my eligibility
What is being tested?
The study tests BMS-986406 alone or combined with Nivolumab and/or platinum-doublet chemotherapy (PDCT) to see how safe it is and how well people tolerate it. It's aimed at those with advanced tumors to find better treatment options.See study design
What are the potential side effects?
Possible side effects may include typical reactions from immunotherapy like fatigue, skin reactions, inflammation of organs as well as those related to chemotherapy such as nausea, hair loss, blood cell count changes leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Stage IV A/B non-small cell lung cancer or recurrent disease and haven't had systemic therapy for it.
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My cancer is advanced and cannot be removed by surgery, but it hasn't spread to my brain.
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My cancer can be measured using specific medical guidelines.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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
Number of participants with AEs leading to discontinuation
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Number of participants with adverse events (AEs)
+2 more
Secondary outcome measures
DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer
DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types
Disease control rate (DCR)
+6 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)Experimental Treatment2 Interventions
Group II: Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or PaclitaxelExperimental Treatment5 Interventions
Group III: Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)Experimental Treatment2 Interventions
Group IV: Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)Experimental Treatment2 Interventions
Group V: Part 1A: BMS-986406 (Monotherapy Dose Escalation)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Carboplatin
2014
Completed Phase 3
~6670
Pemetrexed
2014
Completed Phase 3
~5250
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,130,678 Total Patients Enrolled

Media Library

BMS-986406 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05298592 — Phase 1
Cancer Research Study Groups: Part 1A: BMS-986406 (Monotherapy Dose Escalation), Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation), Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion), Part 2: BMS-986406 + Nivolumab (Expansion Cohorts), Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel
Cancer Clinical Trial 2023: BMS-986406 Highlights & Side Effects. Trial Name: NCT05298592 — Phase 1
BMS-986406 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05298592 — Phase 1
~71 spots leftby Apr 2026
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