An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma (CheckMate 800)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Renal Cell Carcinoma

Treatments: Biological: Opdivo; Biological: Yervoy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03029780

CA209-800

Details and patient eligibility

About

The purpose of this study is to evaluate safety and efficacy of different administration regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.

Enrollment: 104 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 Renal Cell Carcinoma
• Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
• Must have at least 1 lesion with measurable disease

Exclusion Criteria:

• Subjects with active central nervous system metastases
• Subjects who received prior therapy with checkpoint inhibitor
• Subjects with active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Co-Administration

Experimental group

Description:

Nivolumab and Ipilimumab Co-Administration

Treatment:

Biological: Yervoy

Biological: Opdivo

Sequential Administration

Experimental group

Description:

Nivolumab and Ipilimumab Sequential Administration

Treatment:

Biological: Yervoy

Biological: Opdivo