Cabozantinib and Nivolumab among older patients with renal-cell carcinoma, a prospective cohort with geriatric, pharmacologic and patient-reported-outcome evaluation (CABOLD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Gustave Roussy

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

16 May 2025 → ongoing

Decision date (initial)

2025-02-21

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

IPSEN

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy

To describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer

Secondary objectives 5

1. To assess physicians and patients reported tolerance for older patients with metastatic clear cell renal cell cancer treated by nivolumab-cabozantinib.
2. To assess efficacy with radiological response rate, progression free survival, duration of response for older patients with metastatic clear cell renal cell cancer treated by nivolumab-cabozantinib.
3. To assess survival for older patients with metastatic clear cell renal cell cancer treated by nivolumab-cabozantinib.
4. To assess quality of life for older patients with metastatic clear cell renal cell cancer treated by nivolumab-cabozantinib.
5. To assess potential associations between G-CODE parameters and pharmacological monitoring of Cabozantinib with safety, efficacy, and QoL criteria for older patients with metastatic clear cell renal cell cancer treated by nivolumab-cabozantinib.

Conditions and MedDRA coding

Renal carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients ≥ 70 years-old
2. Confirmed advanced or clear-cell 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 7

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
7. Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (except: patients Version 1.0 02/10/24 Confidential Page 6 of 68 included in CARE1 may be included in CABOLD if they are included in the arm B of CARE1 study (EUCT N° 2023-503317-29-00))

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Treatment patterns, including starting dose of Cabozantinib, dose interruption, dose modification related to all grade toxicity at 24 weeks.

Secondary endpoints 8

1. Overall response rate based on radiological evaluation
2. Overall-survival
3. Progression free survival
4. Duration of response
5. Tolerance based on physicians and patients reports
6. Unplanned hospitalizations, emergency departments visits and falls
7. Patients reported quality of life (FACT-G and FACIT-TS-G),
8. Exploratory analyses to assess potential associations between G-CODE parameters and pharmacological monitoring of Cabozantinib with safety, efficacy, and QoL criteria

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Gustave Roussy

Sponsor organisation

Institut Gustave Roussy

Address

114 Rue Edouard Vaillant

City

Villejuif

Postcode

94800

Country

France

Scientific contact point

Organisation

Institut Gustave Roussy

Contact name

Regulatory affairs officer

Public contact point

Organisation

Institut Gustave Roussy

Contact name

Regulatory affairs officer

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications