Advanced or Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
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)
| Verified date | May 2022 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 286 |
| Est. completion date | August 23, 2024 |
| Est. primary completion date | August 23, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Local Institution - 0001 | Tokyo |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to 5 years | ||
| Secondary | Overall Survival (OS) | From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years) | ||
| Secondary | 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) | ||
| Secondary | Change in tumor response over time | Up to 5 years | ||
| Secondary | 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) | ||
| Secondary | 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 | ||
| Secondary | 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) | ||
| Secondary | ORR on subsequent therapy | From initiation of a second line of therapy after discontinuation of first line nivolumab+ipilimumab treatment (Up to 5 years) |
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