Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04349267
• Other study ID #: CA047-004
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 14, 2020
• Est. completion date: May 30, 2025

Study information

• Verified date: February 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 308
• Est. completion date: May 30, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1

• Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor

• Eastern cooperative oncology group performance status of 0 or 1

• Women of childbearing potential must agree to follow methods of contraception

Exclusion Criteria:

• Participants with active, known or suspected autoimmune disease

• Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications

• Uncontrolled or significant cardiovascular disease

• History of or with active interstitial lung disease or pulmonary fibrosis

• Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study

• History of allergy or hypersensitivity to study drug components

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Biological:
• BMS-986315
Specified dose on specified days
• nivolumab
Specified dose on specified days
• cetuximab
Specified dose on specified days

Locations

Country	Name	City	State
Canada	Local Institution - 0014	Edmonton	Alberta
Canada	Local Institution - 0005	Montreal	Quebec
Canada	Local Institution - 0013	Ottawa
Canada	Local Institution - 0004	Toronto	Ontario
Canada	Local Institution - 0011	Vancouver	British Columbia
Mexico	Local Institution	Mexico city	Distrito Federal
United States	Local Institution - 0001	Germantown	Tennessee
United States	Local Institution - 0028	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		Up to 119 weeks
Primary	Incidence of serious adverse events (SAEs)		Up to 119 weeks
Primary	Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria		Up to 119 weeks
Primary	Incidence of adverse events (AEs) leading to discontinuation		Up to 119 weeks
Primary	Number of deaths		Up to 119 weeks
Secondary	Objective Response Rate (ORR)		Up to 12 months
Secondary	Duration of Response (DOR)		Up to 12 months
Secondary	Progression-Free Survival Rate (PFSR)		Up to 12 months
Secondary	Maximum observed serum concentration (Cmax) of BMS-986315		Up to 16 weeks
Secondary	Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab		Up to 16 weeks
Secondary	Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab		Up to 16 weeks
Secondary	Time of maximum observed serum concentration (Tmax) of BMS-986315		Up to 16 weeks
Secondary	Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab		Up to 16 weeks
Secondary	Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab		Up to 16 weeks
Secondary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315		Up to 16 weeks
Secondary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with nivolumab		Up to 16 weeks
Secondary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with cetuximab		Up to 16 weeks
Secondary	Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315		Up to 16 weeks
Secondary	Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with nivolumab		Up to 16 weeks
Secondary	Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with cetuximab		Up to 16 weeks
Secondary	Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315		Up to 16 weeks
Secondary	Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab		Up to 16 weeks
Secondary	Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab		Up to 16 weeks
Secondary	Trough observed serum concentrations (Ctrough) of BMS-986315		Up to 119 weeks
Secondary	Incidence of anti-drug antibodies to BMS-986315		Up to 119 weeks
Secondary	Incidence of anti-drug antibodies to BMS-986315 with nivolumab		Up to 119 weeks
Secondary	Incidence of anti-drug antibodies to BMS-986315 with cetuximab		Up to 119 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting