A Study of the Safety and Tolerability of BMS-986183 in Patients With Liver Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Biological: Nivolumab; Biological: BMS-986183

Study type: Interventional

Funder types: Industry

Identifiers

NCT02828124

CA015-003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of BMS-986183 in patients with liver cancer.

Enrollment: 25 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:

• Must have advanced liver cancer that cannot be treated with surgery or other local methods
• Liver cancer is confirmed by a microscopic examination of tissue
• Liver disease is classified as 'A' by a standard method called Child-Pugh score
• Daily living abilities are classified as '0 or 1' by a standard method from the Eastern Cooperative Oncology Group (ECOG)
• Women must use contraception

Exclusion Criteria:

• Prior liver transplant
• Increase in blood pressure in some of the veins entering the liver
• Cancer that has spread to the brain or the layers of tissue that cover the brain or spinal cord
• Infection with both hepatitis B and C, both hepatitis D and B, infection with HIV, or other infections
• Disease of the heart or blood vessels around the heart
• Active cancers within the last 2 years
• No more than 2 prior systemic treatments or other investigational agents except PD-1/PD-L1 or Ipilimumab (Part 2)
• Currently on anti-platelet or anti-coagulation therapy
• Radiotherapy within 4 weeks of treatment
• Any major allergies

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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25 participants in 4 patient groups

Dose Escalation Monotherapy

Experimental group

Treatment:

Biological: BMS-986183

Dose Expansion Monotherapy

Experimental group

Treatment:

Biological: BMS-986183

Dose Escalation Combination Therapy

Experimental group

Treatment:

Biological: Nivolumab

Biological: BMS-986183

Dose Expansion Combination Therapy

Experimental group

Treatment:

Biological: Nivolumab

Biological: BMS-986183