BMS-986340 for Squamous Cell Carcinoma of the Head and Neck

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Squamous Cell Carcinoma of the Head and Neck+10 MoreBMS-986340 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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
  • Squamous Cell Carcinoma of the Head and Neck
  • Cervical Cancer
  • Gastric Cancer
  • Microsatellite Stable Colorectal Cancer
  • Non-Small Cell Lung Cancer

Video Summary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 14 Secondary · Reporting Duration: At 6 months, 12 months

Month 12
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
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Up to 120 weeks
Incidence of AEs leading to death
Incidence of AEs leading to discontinuation
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Incidence of adverse events (AEs)
Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Incidence of serious adverse events (SAEs)
PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))
PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)
PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)
PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)
PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau)
PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax)
Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Part 1A: BMS-986340 Dose Escalation
1 of 4
Part 1B: BMS-986340 + Nivolumab Dose Escalation
1 of 4
Part 2A: BMS-986340 Dose Expansion
1 of 4
Part 2B: BMS-986340 + Nivolumab Dose Expansion
1 of 4

Experimental Treatment

185 Total Participants · 4 Treatment Groups

Primary Treatment: BMS-986340 · No Placebo Group · Phase 1 & 2

Part 1A: BMS-986340 Dose Escalation
Drug
Experimental Group · 1 Intervention: BMS-986340 · Intervention Types: Drug
Part 1B: BMS-986340 + Nivolumab Dose EscalationExperimental Group · 2 Interventions: BMS-936558-01, BMS-986340 · Intervention Types: Drug, Drug
Part 2A: BMS-986340 Dose Expansion
Drug
Experimental Group · 1 Intervention: BMS-986340 · Intervention Types: Drug
Part 2B: BMS-986340 + Nivolumab Dose ExpansionExperimental Group · 2 Interventions: BMS-936558-01, BMS-986340 · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 6 months, 12 months

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,499 Previous Clinical Trials
3,931,597 Total Patients Enrolled
10 Trials studying Squamous Cell Carcinoma of the Head and Neck
1,438 Patients Enrolled for Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Radiographically documented progressive disease on or after the most recent therapy.
You have measurable disease per RECIST v1.1 and at least 1 lesion accessible for biopsy.