A Study of Nivolumab in Combination With Ipilimumab in Chinese Participants With Previously Treated Advanced or Recurrent Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Ipilimumab; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03195478

CA209-672

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of Nivolumab in combination with Ipilimumab in Chinese participants with previously treated late stage cancer.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mainland Chinese participants with advanced or recurrent solid tumors
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• One prior anti-cancer therapy that did not work or documented refusal to receive chemotherapy or biological therapy

Exclusion criteria

• Cancer that has spread to the brain or central nervous system unless it has been adequately treated . In addition, either no longer receiving corticosteroids, or on a stable or decreasing dose of no more than 10 mg daily prednisone (or equivalent)
• Active, known or suspected autoimmune disease or infection
• Positive blood screen for chronic infection of hepatitis B or hepatitis C (HCV antibody positive unless HCV RNA is negative)
• Prior immuno-oncology therapy

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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37 participants in 4 patient groups

Nivo/Ipi Combination Therapy A

Experimental group

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Nivo/Ipi Combination Therapy B

Experimental group

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Nivo/Ipi Combination Therapy C

Experimental group

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Nivo/Ipi Combination Arm D

Experimental group

Treatment:

Drug: Nivolumab

Drug: Ipilimumab