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This is a French, nationwide, prospective, observational, multi-center study in participants diagnosed with advanced renal cell carcinoma, who start a new systemic therapy with nivolumab with or without ipilimumab for the first time and within the market authorization approval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Nivolumab | Participants diagnosed with advanced renal cell carcinoma (RCC) and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of RCC | ||
| Cohort 2: Nivolumab + Ipilimumab | Participants diagnosed with advanced RCC and whose physician has decided to start a new systemic therapy with nivolumab + ipilimumab for the first time for the treatment of RCC |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | By Cohort | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 3 years | |
| Progression Free Survival (PFS) | Up to 3 years | |
| Overall Response Rate (ORR) |
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Inclusion Criteria:
-Adult participants with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically) whose physician has already decided to initiate a treatment with nivolumab with or without ipilimumab for the first time for the treatment of RCC, according to the label approved in France
NOTE: Nivolumab with ipilimumab is indicated for the first-line treatment of adult participants with intermediate/poor-risk advanced RCC
Exclusion Criteria:
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Adult participants who are at least 18 of age at the time of the treatment decision with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with nivolumab or with nivolumab plus ipilimumab for the first time for the treatment of RCC, according to the label approved in France.
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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 | Paris | 75002 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38897136 | Derived | Barthelemy P, Albiges L, Escudier B, Narciso B, Bigot P, Chehimi M, Emambux S, Calcagno F, Mouillet G, Eymard JC, Schlurmann F, Bailly S, Garbay D, Berdah JF, Palmaro MB, Goupil MG, Spaeth D, Nere S, Quentric C, Vano YA, Thiery-Vuillemin A. Nivolumab in patients with advanced renal cell carcinoma in France: interim results of the observational, real-world WITNESS study. ESMO Open. 2024 Jul;9(7):103602. doi: 10.1016/j.esmoop.2024.103602. Epub 2024 Jun 18. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| Up to 3 years |
| Best Overall Response Rate (BORR) | Up to 3 years |
| Best Overall Response (BOR) | Up to 3 years |
| Distribution of socio-demographic characteristics of participants | Approximately 3 years |
| Distribution of clinical characteristics of participants | Approximately 3 years |
| Distribution of management of participants with treatment-related adverse events (AEs) | Approximately 3 years |
| Distribution of management of participants according to Memorial Sloan Kettering Cancer Center (MSKCC) score | At baseline |
| Distribution of management of participants according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score | At baseline |
| Distribution of treatment patterns in participants with advanced Renal Cell Carcinoma (RCC) | Approximately 3 years |
| Distribution of incidence of AEs | Approximately 3 years |
| Distribution of Severity of AEs | Approximately 3 years |
| Distribution of management of AEs | Approximately 3 years |
| Health-related quality of life of participants using Functional Assessment of Cancer Therapy -Kidney Symptom Index (FKSI-19) questionnaires | The FKSI-19 will be graded by the patient on a scale from 0 to 4 (range "not at all to very much") | Approximately 3 years |
| Health-related quality of life of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires | The EQ-5D descriptive system consists of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression, each with 3 levels (eg, no problems, moderate problems, extreme problems) | Approximately 3 years |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | 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 |
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