Clinical trial · Observational
A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan
Japanese Prospective Real World Registry of Nivolumab Plus Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (ARCC) Categorized Into IMDC Intermediate/Poor Risks (J-ENCORE)
NCT04043975CI-TRIAL-00086049completedClinicalTrials.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)
The purpose of the observational study is to evaluate the safety and effectiveness of combination therapy with nivolumab and ipilimumab in Japanese participants with advanced or metastatic renal cell carcinoma (aRCC) in the real-world setting in Japan.
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 |
|---|---|---|---|
| Advanced or Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- Participants with advanced or metastatic renal cell carcinoma (aRCC) receiving the combination of nivolumab plus ipilimumab as the first line of systemic therapy
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 5 years
Secondary outcomes (7)
- measure
- Overall Survival (OS)
- timeFrame
- From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years)
- measure
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator
- timeFrame
- From date of starting nivolumab plus ipilimumab to the first date of documented progression, as determined by the investigators (as per RECIST 1.1 criteria), or death due to any cause, whichever occurs first. (Up to 5 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of Renal Cell Carcinoma (RCC) * No prior systemic therapy for RCC * Participants who are planned to start treatment with nivolumab and ipilimumab regimen in the timeframe between after IRB approval to enrollment-end date * International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category Intermediate/Poor Exclusion Criteria: * Participants who are enrolled in a post marketing safety study on nivolumab plus ipilimumab combination therapy in Japan * Pregnant and/or lactating women * Participants who are judged to be inappropriate by investigator Other protocol-defined inclusion/exclusion criteria apply.
References
Publications (3)
- DERIVEDHamamoto S, Nozawa M, Shirotake S, Sazuka T, Numakura K, Mizokami A, Kondo T, Naito S, Abe T, Ohba K, Kimura G, Nagata M, Onodera S, Yamaguchi K, Uemura H. A Minimum 3-Year Follow-Up of Nivolumab-Plus-Ipilimumab in Japanese Patients With Advanced or Metastatic Renal Cell Carcinoma: A Final Analysis of the J-ENCORE Study. Int J Urol. 2026 Mar;33(3):e70400. doi: 10.1111/iju.70400. PMID 41841331
- DERIVEDSazuka T, Tatsugami K, Shirotake S, Hamamoto S, Nozawa M, Numakura K, Mizokami A, Kondo T, Naito S, Abe T, Ohba K, Kimura G, Onodera S, Yamaguchi K, Uemura H. Outcomes of Nivolumab-Plus-Ipilimumab in Metastatic Renal Cell Carcinoma: Second Interim Analysis of the J-ENCORE Study. Int J Urol. 2026 Jan;33(1):e70281. doi: 10.1111/iju.70281. Epub 2025 Nov 25. PMID 41292059
- DERIVEDNishimoto K, Kimura G, Sazuka T, Hamamoto S, Nozawa M, Numakura K, Mizokami A, Kondo T, Naito S, Abe T, Ohba K, Nagata M, Onodera S, Ito H, Uemura H. The Effectiveness and Safety Profile of Nivolumab-Plus-Ipilimumab in Previously Untreated Japanese Patients With Advanced or Metastatic Renal Cell Carcinoma (J-ENCORE Study). Int J Urol. 2025 Aug;32(8):961-972. doi: 10.1111/iju.70076. Epub 2025 Apr 24. PMID 40271863