First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Advanced Cancer

Treatments: Biological: Ipilimumab; Biological: Nivolumab; Biological: BMS-986218

Study type: Interventional

Funder types: Industry

Identifiers

NCT03110107

2017-000597-11 (EudraCT Number)

CA022-001

Details and patient eligibility

About

The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.

Enrollment: 376 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists
• Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
• Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B & 2C)
• Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D)

Exclusion Criteria:

• Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
• Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
• Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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376 participants in 6 patient groups

Part 1A: Monotherapy (BMS-986218)

Experimental group

Treatment:

Biological: BMS-986218

Part 1B: Combination Therapy (BMS-986218 + Nivolumab)

Experimental group

Treatment:

Biological: BMS-986218

Biological: Nivolumab

Part 2A: Monotherapy (BMS-986218 OR Ipilimumab)

Experimental group

Treatment:

Biological: BMS-986218

Biological: Ipilimumab

Part 2B: Monotherapy (BMS-986218)

Experimental group

Treatment:

Biological: BMS-986218

Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab)

Experimental group

Treatment:

Biological: BMS-986218

Biological: Nivolumab

Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab)

Experimental group

Treatment:

Biological: BMS-986218

Biological: Nivolumab