A Study of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: BMS-986205; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03792750

CA017-076

Details and patient eligibility

About

The purpose of this study is to determine safety and effectiveness of experimental medication BMS-986205 in combination with Nivolumab in patients with cancers that are advanced or have spread.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have histologic or cytological confirmation of a solid tumor that is advanced with measureable disease per RECIST v1.1
• Participants must have received, and then progressed or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting
• Participants must have an ECOG performance status of less than or equal to 1
• Participants must have at least 1 lesion with measurable disease as defined by RECIST Version 1.1

Exclusion criteria

• Participants must not have suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease
• Participants with prior exposure to anti PD-1 or anti-PDL1 therapy
• Participants must not have a history of allergy to any of the study treatment components

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Experimental Arm A

Experimental group

Description:

2 week BMS-986205 monotherapy lead in followed by BMS-986205 + Nivo combination therapy

Treatment:

Drug: BMS-986205

Biological: Nivolumab