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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with advanced or metastatic renal cell carcinoma (aRCC) receiving the combination of nivolumab plus ipilimumab as the first line of systemic therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years) | |
| Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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The study population consists of Japanese participants who will be treated with the combination of nivolumab+ipilimumab as first line of systematic therapy in the real world setting.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Tokyo | 1070052 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41841331 | Derived | Hamamoto 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. | |
| 41292059 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Change in tumor response over time | Up to 5 years |
| Duration of Response (DOR) | From first documentation of tumor response after the date of starting nivolumab plus ipilimumab to disease progression or death due to any cause, whichever occurs first. (Up to 5 years) |
| The quality of life by National Comprehensive Cancer Network/ Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) v2.0 | Up to 6 months |
| Number of participants with Adverse Events (AEs) | During the observation period or until 100 days after discontinuation of dosing with nivolumab and ipilimumab (Up to 5 years) |
| ORR on subsequent therapy | From initiation of a second line of therapy after discontinuation of first line nivolumab+ipilimumab treatment (Up to 5 years) |
| Derived |
| Sazuka 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. |
| 40271863 | Derived | Nishimoto 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. |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |