A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer (CHECKMATE 920)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Renal Cell Carcinoma

Treatments: Drug: Ipilimumab; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02982954

CA209-920

Details and patient eligibility

About

To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Type of Participant and Target Disease Characteristics

2. Advanced or metastatic RCC

3. Histologically confirmed, previously untreated (treatment-naive) RCC

4. No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC

5. Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease

6. Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4

7. Tumor tissue need be received by the central vendor (block or unstained slides). Note: Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for submission.

Exclusion criteria

1. Medical Conditions

   1. Subjects with any active autoimmune disease or a history of known autoimmune disease
   2. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
   3. Known HIV or AIDS-related illness
   4. Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.

2. Prior/Concomitant Therapy

   1. Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy
   2. Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2, anti-cluster of differentiation 137 (CD137), or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. This includes the utilization of these agents in the neo-adjuvant or adjuvant setting.
   3. Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.

Other protocol defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 4 patient groups

ccRCC KPS ≥ 70%

Experimental group

Description:

Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Non-ccRCC, KPS ≥ 70%

Experimental group

Description:

Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

RCC with non-active Brain Mets, KPS ≥70%

Experimental group

Description:

Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

any RCC with KPS 50%-60%

Experimental group

Description:

Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%

Treatment:

Drug: Nivolumab

Drug: Ipilimumab