Clinical trial · Interventional
A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer
Phase 3b/4 Safety Trial of Nivolumab Combined With Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic RCC (CheckMate 920: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 920)
NCT02982954CI-TRIAL-00061835CHECKMATE 920completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- ccRCC KPS ≥ 70%
- description
- Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%
- interventionNames
- Drug: Nivolumab
- Drug: Ipilimumab
- type
- EXPERIMENTAL
- label
- Non-ccRCC, KPS ≥ 70%
- description
- Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%
- interventionNames
- Drug: Nivolumab
- Drug: Ipilimumab
- type
- EXPERIMENTAL
- label
- RCC with non-active Brain Mets, KPS ≥70%
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Type of Participant and Target Disease Characteristics 1. Advanced or metastatic RCC 2. Histologically confirmed, previously untreated (treatment-naive) RCC 3. No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC 4. Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease 5. Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4 6. 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
References
Publications (2)
- DERIVEDGeorge DJ, Spigel DR, Gordan LN, Kochuparambil ST, Molina AM, Yorio J, Rezazadeh Kalebasty A, McKean H, Tchekmedyian N, Tykodi SS, Zhang J, Askelson M, Johansen JL, Hutson TE. 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. BMJ Open. 2022 Sep 14;12(9):e058396. doi: 10.1136/bmjopen-2021-058396. PMID 36104138
- DERIVEDTykodi SS, Gordan LN, Alter RS, Arrowsmith E, Harrison MR, Percent I, Singal R, Van Veldhuizen P, George DJ, Hutson T, Zhang J, Zoco J, Johansen JL, Rezazadeh Kalebasty A. 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. J Immunother Cancer. 2022 Feb;10(2):e003844. doi: 10.1136/jitc-2021-003844. PMID 35210307