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| ID | Type | Description | Link |
|---|---|---|---|
| 2024/3873 | Other Identifier | CSET number (Gustave Roussy ID) |
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| Name | Class |
|---|---|
| Ipsen | INDUSTRY |
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The goal of the study is to describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer
This study will be a prospective, multicentric, single-arm cohort. Patients will receive Nivolumab-Cabozantinib association per standard. All patients will benefit of geriatric evaluation (G-CODE) at inclusion, and a multimodal and reinforced follow-up, including medical oncologist, geriatrician nurse of doctor, phone calls, and optional pharmacological follow-up for Cabozantinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabozantinib-Nivolumab | Experimental | The patient will be treated according to standard of care Nivolumab Cabozantinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Starting dose of Cabozantinib | Primary outcome measure is treatment patterns, which includes starting dose of cabozantinib. | 24 weeks after treatment start |
| Dose interruption of Cabozantinib | Primary outcome measure is treatment patterns of Cabozantinib, which includes the proportion of patients who experience any temporary dose interruption within the first 24 weeks of treatment. | 24 weeks after treatment start |
| Dose modifications of Cabozantinib | Primary outcome measure is treatment patterns, which includes the proportion of patients who experience any form of dose modification of Cabozantinib related to all grade toxicity within the first 24 weeks of treatment. | 24 weeks after treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate based on radiological evaluation | Overall response rate based on best radiological response rate with local RECIST 1.1 evaluation observed in the 12 months of the study | 12 months after treatment start |
| Overall-survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maxime Frelaut, MD | Contact | +33 1 42 11 57 60 | Maxime.FRELAUT@gustaveroussy.fr | |
| Maia Claveau CLAVEAU | Contact | +33 1 42 11 53 49 | maia.claveau@gustaveroussy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Maxime FRELAUT, MD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'Ouest - Angers | Not yet recruiting | Angers | 49055 | France |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C558660 | cabozantinib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Cabozantinib | Drug | Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day. |
|
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Defined as the time between the date of inclusion and the date of death whatever the cause. Patients alive at the date of last follow-up visit will be censored at that date.
| 12 months after treatment start |
| Progression free survival | Progression free survival, defined by the time between inclusion date and the date of observation of a progression of the disease according to RECIST 1.1 or death of the patient (all causes combined) or date of last follow-up if the patient is alive without progression or lost to follow up. | 12 months after treatment start |
| Duration of response | It is defined as the time from first radiological evidence of response (partial or complete response) to disease progression or death among patients who achieve complete or partial response. | 12 months after treatment start |
| Frequency of adverse events according to CTCAE V5 | Tolerance is evaluated based on physicians reports. | 12 months after treatment start |
| Frequency of adverse events according to PRO-CTCAE | Tolerance is evaluated based on patients reports. | 12 months after treatment start |
| Quality of life - Patient-related outcomes - FACT-G | Patients reported quality of life is evaluated based on Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. It is an 27 item questionnaire, ranging from 0 to 108 score. Higher scores indicate better quality of life | At baseline, and every 3 months after treatment start, up to 12 months after treatment start |
| Quality of life - Patient-related outcomes - FACIT TS-G | Patients reported quality of life is evaluated based on Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT TS-G) questionnaire. The score range goes from 0 to 70 score. Higher scores indicate greater satisfaction with treatment | Every 3 months after treatment start, up to 12 months after treatment start |
| Centre Georges François Leclerc | Not yet recruiting | Dijon | 21079 | France |
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| Centre Léon Bérard | Not yet recruiting | Lyon | 69373 | France |
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| Hôpital Tenon | Not yet recruiting | Paris | 75020 | France |
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| Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud | Not yet recruiting | Toulouse | 31059 | France |
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| CHU Tours - Hôpital Bretonneau | Not yet recruiting | Tours | 37044 | France |
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| Gustave Roussy | Recruiting | Villejuif | 94800 | France |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |