Phase 4
Completed N=211
A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer
Source: ClinicalTrials.gov NCT02982954 ↗Enrolled (actual)
211
Serious AEs
58.3%
Results posted
Oct 2021
Primary outcomePrimary: Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs) — 1; 0; 0; 0 Participants
◆ Published Evidence
Highly cited
136citations · ~34 / year
Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial.
Summary
To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.
Linked Publications (2)
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Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial.
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Safety and efficacy of first-line nivolumab plus ipilimumab alternating with nivolumab monotherapy in patients with advanced renal cell carcinoma: the non-randomised, open-label, phase IIIb/IV CheckMate 920 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs) |
1; 0; 0; 0; 8; 4 | — |
| PRIMARY Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs) |
12.7; 21.79; 10.43; 11.0; 8.43; 9.4 | — |
| SECONDARY Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs) |
0.9; 2.71; 5.93; 1.14; NA; NA | — |
| SECONDARY Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs) |
1; 0; 0; 0; 8; 4 | — |
| SECONDARY Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs) |
1; 0; 0; 0; 8; 3 | — |
| SECONDARY Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs) |
19; 9; 5; 2 | — |
| SECONDARY Median Progression Free Survival (PFS) |
4.8; 3.7; 8.5; 3.6 | — |
| SECONDARY Objective Response Rate (ORR) |
35.4; 21.7; 30.8; 33.3 | — |
| SECONDARY Time to Response Rate (TRR) |
2.8; 2.8; 2.8; 4.5 | — |
| SECONDARY Duration of Response (DOR) |
11.01; 37.68; 16.51; 19.48 | — |
Eligibility Criteria
Inclusion Criteria
- Type of Participant and Target Disease Characteristics
- Advanced or metastatic RCC
- Histologically confirmed, previously untreated (treatment-naive) RCC
- No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC
- Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease
- Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4
- 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
- Medical Conditions
- Subjects with any active autoimmune disease or a history of known autoimmune disease
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
- Known HIV or AIDS-related illness
- Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
- Prior/Concomitant Therapy
- Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy
- 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.
- 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
Data sourced from ClinicalTrials.gov (NCT02982954) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.