Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma

NCT06934057 | Recruiting Phase 4

• 2 other identifiers: 2024-516650-22-002024/3873
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Kidney Cancer; Renal Cell Cancer

Keywords

renal cell carcinoma; kidney cancer; cabozantinib; nivolumab; elderly patients; geriatric population

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (8)

• Overall response rate based on radiological evaluation

  12 months after treatment start

• Overall-survival

  12 months after treatment start

• Progression free survival

  12 months after treatment start

• Duration of response

  12 months after treatment start

• Frequency of adverse events according to CTCAE V5

  12 months after treatment start

Study Arms (1)

Cabozantinib-Nivolumab

EXPERIMENTAL

The patient will be treated according to standard of care Nivolumab Cabozantinib.

Drug: Nivolumab; Drug: Cabozantinib

Interventions

Nivolumab DRUG

Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.

Also known as: OPDIVO

Cabozantinib-Nivolumab

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.

Also known as: CABOMETYX

Cabozantinib-Nivolumab

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients ≥ 70 years-old
• Confirmed advanced or metastatic renal-cell carcinoma
• Patients not previously treated in metastatic setting
• Performance Status 0 to 2
• Sexually active male patients must agree to use condom during the study and for at least 5 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.
• Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
• Patients must be affiliated to a social security system or beneficiary of the same

You may not qualify if:

• Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (Patients may be included in CABOLD if they are included in the arm B of CARE1 study EUCT N° 2023-503317-29-00)
• Performance Status \> 2
• Any severe cardiovascular or thrombo-embolic event in the last three months
• Any situation for which exclusive palliative care intervention is recommended
• Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• Ipsen: collaborator

Study Sites (7)

Institut de Cancérologie de l'Ouest - Angers

Angers, 49055, France

NOT YET RECRUITING

Centre Georges François Leclerc

Dijon, 21079, France

NOT YET RECRUITING

Centre Léon Bérard

Lyon, 69373, France

NOT YET RECRUITING

Hôpital Tenon

Paris, 75020, France

NOT YET RECRUITING

Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud

Toulouse, 31059, France

NOT YET RECRUITING

CHU Tours - Hôpital Bretonneau

Tours, 37044, France

NOT YET RECRUITING

Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Nivolumab; cabozantinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Maxime FRELAUT, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 18, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)