A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04895709

Collaborator

(none)

185

Enrollment

Locations

Arms

50.9

Anticipated Duration (Months)

9.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Gastric/Gastroesophageal Junction Adenocarcinoma Microsatellite Stable Colorectal Cancer Non-Small-Cell Lung Cancer Squamous Cell Carcinoma of Head and Neck	Drug: BMS-986340 Drug: BMS-936558-01	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

185 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Actual Study Start Date :

May 27, 2021

Anticipated Primary Completion Date :

Mar 28, 2024

Anticipated Study Completion Date :

Aug 23, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1A: BMS-986340 Dose Escalation	Drug: BMS-986340 Specified dose on specified days
Experimental: Part 2A: BMS-986340 Dose Expansion	Drug: BMS-986340 Specified dose on specified days
Experimental: Part 1B: BMS-986340 + Nivolumab Dose Escalation	Drug: BMS-986340 Specified dose on specified days Drug: BMS-936558-01 Specified dose on specified days Other Names: Nivolumab
Experimental: Part 2B: BMS-986340 + Nivolumab Dose Expansion	Drug: BMS-986340 Specified dose on specified days Drug: BMS-936558-01 Specified dose on specified days Other Names: Nivolumab

Outcome Measures

Primary Outcome Measures

Incidence of adverse events (AEs) [Up to 120 weeks]
Incidence of serious adverse events (SAEs) [Up to 120 weeks]
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [Up to 120 weeks]
Incidence of AEs leading to discontinuation [Up to 120 weeks]
Incidence of AEs leading to death [Up to 120 weeks]
Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 120 weeks]
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [Up to 120 weeks]
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 120 weeks]

Secondary Outcome Measures

Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) [Up to 120 weeks]
PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) [Up to 120 weeks]
PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU)) [Up to 120 weeks]
PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) [Up to 120 weeks]
PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) [Up to 120 weeks]
PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) [Up to 120 weeks]
PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) [Up to 120 weeks]
PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau) [Up to 120 weeks]
Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy [Up to 120 weeks]
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab [Up to 120 weeks]
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [At 6 months, 12 months]
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [At 6 months, 12 months]
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [At 6 months, 12 months]
Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [At 6 months, 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Radiographically documented progressive disease on or after the most recent therapy
Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
Parts 1A, 1B, and 2A: Advanced or metastatic non-small cell lung cancer, squamous cell carcinoma of head and neck, microsatellite stable colorectal cancer, gastric/ gastroesophageal junction adenocarcinoma, or cervical cancer, and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant

Exclusion Criteria:

Women who are pregnant or breastfeeding
Primary central nervous system (CNS) malignancy
Untreated CNS metastases
Leptomeningeal metastases
Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
Active, known, or suspected autoimmune disease
Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
Prior organ or tissue allograft
Uncontrolled or significant cardiovascular disease
Major surgery within 4 weeks of study drug administration
History of or with active interstitial lung disease or pulmonary fibrosis

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	La Jolla	California	United States	92093
2	John Theurer Cancer Center	Hackensack	New Jersey	United States	07601
3	Columbia University Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical Protoco	New York	New York	United States	10032
4	Memorial Sloan Kettering Nassau	New York	New York	United States	10065
5	Providence Cancer Center Oncology and Hematology Care- Eastside	Portland	Oregon	United States	97213
6	Local Institution	Edmonton	Alberta	Canada	T6G 1Z2
7	Local Institution - 0009	Toronto	Ontario	Canada	M5G 2M9
8	Local Institution	Montreal	Quebec	Canada	H2X 3E4
9	Local Institution - 0016	Ottawa		Canada	K1H 8L6
10	Local Institution	Dresden		Germany	01307
11	Local Institution	Essen		Germany	45147
12	Local Institution	Frankfurt		Germany	60590
13	Local Institution	Würzburg		Germany	97078
14	Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1	Milan		Italy	20133
15	Local Institution	Rozzano		Italy	20089
16	Local Institution	Siena		Italy	53100
17	Local Institution	Badalona		Spain	08916
18	Local Institution - 0013	Madrid		Spain	28040
19	Local Institution - 0011	Madrid		Spain	28050
20	Local Institution - 0012	Pamplona		Spain	31008