Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma (CABOLD)

Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation

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

Study Overview

• Status: Recruiting
• Conditions: Kidney Cancer; Renal Cell Cancer
• Intervention / Treatment: Drug: Cabozantinib; Drug: Nivolumab

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maxime Frelaut, MD; Phone Number: +33 1 42 11 57 60; Email: Maxime.FRELAUT@gustaveroussy.fr
• Study Contact Backup: Name: Maia Claveau CLAVEAU; Phone Number: +33 1 42 11 53 49; Email: maia.claveau@gustaveroussy.fr

Study Locations

• France
  • Angers, France, 49055
    • Not yet recruiting
    • Institut de Cancérologie de l'Ouest - Angers
    • Contact: Elouen BOUGHALEM, MD; Phone Number: +33 2 41 35 27 00; Email: Elouen.boughalem@ico.unicancer.fr
  • Dijon, France, 21079
    • Not yet recruiting
    • Centre Georges François Leclerc
    • Contact: Leila BENGRINE, MD; Phone Number: +33 380737528; Email: lbengrine@cgfl.fr
  • Lyon, France, 69373
    • Not yet recruiting
    • Centre Leon Berard
    • Contact: Helen BOYLE, MD; Phone Number: +33 426556752; Email: helen.boyle@lyon.unicancer.fr
  • Paris, France, 75020
    • Not yet recruiting
    • Hopital Tenon
    • Contact: Djamel GHEBRIOU, MD; Phone Number: +33 156017724; Email: djamel.ghebriou@aphp.fr
  • Toulouse, France, 31059
    • Not yet recruiting
    • Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud
    • Contact: Loïc MOUREY, MD; Phone Number: +33 531155156; Email: mourey.loic@iuct-oncopole.fr
  • Tours, France, 37044
    • Not yet recruiting
    • CHU Tours - Hôpital Bretonneau
    • Contact: Mathilde CANCEL, MD; Phone Number: +33 2 47 47 99 99; Email: m.cancel@chu-tours.fr
  • Villejuif, France, 94800
    • Recruiting
    • Gustave Roussy
    • Contact: Maxime FRELAUT, MD; Phone Number: +33 142115760; Email: Maxime.frelaut@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients ≥ 70 years-old
2. Confirmed advanced or metastatic renal-cell carcinoma
3. Patients not previously treated in metastatic setting
4. Performance Status 0 to 2
5. 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.
6. 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.
7. Patients must be affiliated to a social security system or beneficiary of the same

Exclusion Criteria:

1. 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)
2. Performance Status > 2
3. Any condition that represent a contraindication to Cabozantinib and/or Nivolumab, as described in summaries of products characteristics, including symptomatic untreated brain metastasis or active auto-immune disease requiring systemic immunosuppressant/modulator (thyroid or adrenal disorder are not an exclusion criteria)
4. Any severe cardiovascular or thrombo-embolic event in the last three months
5. Any situation for which exclusive palliative care intervention is recommended
6. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cabozantinib-Nivolumab; The patient will be treated according to standard of care Nivolumab Cabozantinib.	Drug: Cabozantinib; Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day.; Other Names: CABOMETYX; Drug: Nivolumab; Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.; Other Names: OPDIVO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Collaborators: Ipsen
• Investigators: Principal Investigator: Maxime FRELAUT, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: kidney cancer; nivolumab; cabozantinib; renal cell carcinoma; elderly patients; geriatric population
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; cabozantinib
• Other Study ID Numbers: 2024-516650-22-00; 2024/3873 (Other Identifier: CSET number (Gustave Roussy ID))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No