A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Tumors; Neoplasm; Cancer; Malignancy

Treatments: Biological: Ipilimumab; Biological: Nivolumab; Biological: Tetanus Vaccine; Drug: BMS-986226

Study type: Interventional

Funder types: Industry

Identifiers

NCT03251924

CA021-002

2017-000238-73 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.

Enrollment: 80 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:

• Advanced solid tumors
• Histological or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or PCWG3 (prostate only).
• At least 1 lesion 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
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Exclusion Criteria:

• Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded (controlled brain metastases will be allowed to enroll)
• Participants with carcinomatous meningitis
• Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
• Active, known, or suspected autoimmune disease
• Uncontrolled or significant cardiovascular disease
• Participants with known allergies to egg products, neomycin and tetanus toxoid.
• Prior adverse reaction to tetanus toxoid- containing vaccines.

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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80 participants in 3 patient groups

BMS-986226

Experimental group

Description:

administered intravenously

Treatment:

Drug: BMS-986226

Biological: Tetanus Vaccine

BMS-986226 and Nivolumab

Experimental group

Description:

administered intravenously

Treatment:

Drug: BMS-986226

Biological: Tetanus Vaccine

Biological: Nivolumab

BMS-986226 and Ipilimumab

Experimental group

Description:

administered intravenously

Treatment:

Drug: BMS-986226

Biological: Tetanus Vaccine

Biological: Ipilimumab