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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04349267
• Collaborator: (none)
• Enrollment: 308
• Locations: 15
• Arms: 3
• Anticipated Duration (Months): 58.5
• Patients Per Site: 20.5
• Patients Per Site Per Month: 0.4

Study Details

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	Intervention/Treatment	Phase
Advanced Solid Tumor	Biological: BMS-986315; Biological: nivolumab; Biological: cetuximab	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 308 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 14, 2020
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: May 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986315	Biological: BMS-986315; Specified dose on specified days
Experimental: BMS-986315 + nivolumab	Biological: BMS-986315; Specified dose on specified days; Biological: nivolumab; Specified dose on specified days
Experimental: BMS-986315 + cetuximab	Biological: BMS-986315; Specified dose on specified days; Biological: cetuximab; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Incidence of adverse events (AEs) [Up to 119 weeks]

2. Incidence of serious adverse events (SAEs) [Up to 119 weeks]

3. Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria [Up to 119 weeks]

4. Incidence of adverse events (AEs) leading to discontinuation [Up to 119 weeks]

5. Number of deaths [Up to 119 weeks]

Secondary Outcome Measures

1. Objective Response Rate (ORR) [Up to 12 months]

2. Duration of Response (DOR) [Up to 12 months]

3. Progression-Free Survival Rate (PFSR) [Up to 12 months]

4. Maximum observed serum concentration (Cmax) of BMS-986315 [Up to 16 weeks]

5. Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab [Up to 16 weeks]

6. Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab [Up to 16 weeks]

7. Time of maximum observed serum concentration (Tmax) of BMS-986315 [Up to 16 weeks]

8. Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab [Up to 16 weeks]

9. Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab [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 [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 [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 [Up to 16 weeks]

13. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 [Up to 16 weeks]

14. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with nivolumab [Up to 16 weeks]

15. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with cetuximab [Up to 16 weeks]

16. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 [Up to 16 weeks]

17. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab [Up to 16 weeks]

18. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab [Up to 16 weeks]

19. Trough observed serum concentrations (Ctrough) of BMS-986315 [Up to 119 weeks]

20. Incidence of anti-drug antibodies to BMS-986315 [Up to 119 weeks]

21. Incidence of anti-drug antibodies to BMS-986315 with nivolumab [Up to 119 weeks]

22. Incidence of anti-drug antibodies to BMS-986315 with cetuximab [Up to 119 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Baltimore	Maryland	United States	21287
2	Sanford Clinic Clinical Research	Sioux Falls	South Dakota	United States	57104
3	The West Clinic, P.C.	Germantown	Tennessee	United States	38138
4	Local Institution	Capital Federal	Distrito Federal	Argentina	C1428
5	Local Institution - 0011	Vancouver	British Columbia	Canada	V5Z 4E6
6	Local Institution	Vancouver	British Columbia	Canada	V5Z 4E6
7	Local Institution	Ottawa	Ontario	Canada	K1H 8L6
8	Local Institution	Toronto	Ontario	Canada	M5G 1Z5
9	Local Institution	Montreal	Quebec	Canada	H2X 3E4
10	Local Institution - 0014	Edmonton		Canada	T6X 1E8
11	Local Institution - 0013	Ottawa		Canada	K1H 8L6
12	Local Institution	Recoleta	Metropolitana	Chile
13	Local Institution	Mexico city	Distrito Federal	Mexico	06100
14	Local Institution	Monterrey	Nuevo LEON	Mexico	64460
15	Local Institution	San Luis Potosi		Mexico	78250

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04349267
• Other Study ID Numbers: CA047-004
• First Posted: Apr 16, 2020
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 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; Nivolumab; Cetuximab

Study Results

No Results Posted as of Jun 24, 2022