Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT04349267 Recruiting April 16, 2020 June 24, 2022

study description
Brief 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.

Condition or Disease: Advanced Solid Tumor
Intervention/treatment: Biological: BMS-986315
Biological: nivolumab
Biological: cetuximab
Phase: Phase 1/Phase 2
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 308 participants
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Actual Study Start Date: July 2020
Estimated Primary Completion Date: April 2024
Estimated Study Completion Date: May 2025

Arms and interventions
Arm Intervention/treatment
Experimental: BMS-986315
Biological: BMS-986315
Specified dose on specified days
Experimental: BMS-986315 + cetuximab
Biological: BMS-986315
Specified dose on specified days

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

Biological: nivolumab
Specified dose on specified days
outcome measures
Primary Outcome Measures: 1. Incidence of adverse events (AEs) [ Time Frame: Up to 119 weeks ]
2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 119 weeks ]
3. Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria [ Time Frame: Up to 119 weeks ]
4. Incidence of adverse events (AEs) leading to discontinuation [ Time Frame: Up to 119 weeks ]
5. Number of deaths [ Time Frame: Up to 119 weeks ]
Secondary Outcome Measures: 1. Objective Response Rate (ORR) [ Time Frame: Up to 12 months ]
2. Duration of Response (DOR) [ Time Frame: Up to 12 months ]
3. Progression-Free Survival Rate (PFSR) [ Time Frame: Up to 12 months ]
4. Maximum observed serum concentration (Cmax) of BMS-986315 [ Time Frame: Up to 16 weeks ]
5. Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
6. Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
7. Time of maximum observed serum concentration (Tmax) of BMS-986315 [ Time Frame: Up to 16 weeks ]
8. Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
9. Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
10. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 [ Time Frame: Up to 16 weeks ]
11. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
12. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
13. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 [ Time Frame: Up to 16 weeks ]
14. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
15. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
16. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 [ Time Frame: Up to 16 weeks ]
17. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ]
18. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ]
19. Trough observed serum concentrations (Ctrough) of BMS-986315 [ Time Frame: Up to 119 weeks ]
20. Incidence of anti-drug antibodies to BMS-986315 [ Time Frame: Up to 119 weeks ]
21. Incidence of anti-drug antibodies to BMS-986315 with nivolumab [ Time Frame: Up to 119 weeks ]
22. Incidence of anti-drug antibodies to BMS-986315 with cetuximab [ Time Frame: Up to 119 weeks ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

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


Contacts and Locations
Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations
United States, Maryland Local Institution Baltimore
United States, South Dakota Sanford Clinic Clinical Research Sioux Falls
United States, Tennessee The West Clinic, P.C. Germantown
Argentina, Distrito Federal Local Institution Capital Federal
Canada, British Columbia Local Institution - 0011 Vancouver
Canada, British Columbia Local Institution Vancouver
Canada, Ontario Local Institution Ottawa
Canada, Ontario Local Institution Toronto
Canada, Quebec Local Institution Montreal
Canada Local Institution - 0014 Edmonton
Canada Local Institution - 0013 Ottawa
Chile, Metropolitana Local Institution Recoleta
Mexico, Distrito Federal Local Institution Mexico city
Mexico, Nuevo LEON Local Institution Monterrey
Mexico Local Institution San Luis Potosi
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT04349267     
Other Study ID Numbers : CA047-004
First Posted : April 16, 2020
Last Update Posted : June 24, 2022
Last Verified : June 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb: NSCLC (Non-small cell lung cancer)
RCC (Renal cell carcinoma)
SCCHN (Squamous cell carcinoma of the head and neck)
Additional relevant MeSH terms :
Neoplasms