An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Cancer

Treatments: Biological: BMS-986277; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03363776

CA034-001

2017-002199-24 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.

Enrollment: 10 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:

• Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3
• Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be accessible for biopsy in addition to the target lesion
• Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment
• ECOG performance status less than or equal to 2

Exclusion Criteria:

• Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease
• Participants with carcinomatous meningitis
• Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment
• Participants with active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Monotherapy

Experimental group

Description:

BMS-986277 administered alone

Treatment:

Biological: BMS-986277

Combination Dose Escalation Therapy

Experimental group

Description:

BMS-986277 administered in combination with Nivolumab

Treatment:

Biological: Nivolumab

Biological: BMS-986277

Combination Expansion Therapy

Experimental group

Description:

BMS-986277 monotherapy with option for subsequent Nivolumab therapy

Treatment:

Biological: Nivolumab

Biological: BMS-986277