A PHASE II, MULTICENTRE, OPEN-LABEL STUDY OF CABOZANTINIB AS 2ND LINE TREATMENT IN SUBJECTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA WITH A CLEAR-CELL COMPONENT WHO PROGRESSED AFTER 1ST LINE TREATMENT WITH CHECKPOINT INHIBITORS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514479-16-00

Acronym

F-FR-60000-023

Enrollment

Registered

2024-08-01

Start date

2019-10-28

Completion date

Unknown

Last updated

2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable, Locally Advanced or Metastatic Renal Cell Carcinoma with a Clear-Cell Component Who Progressed After 1st Line Treatment with Checkpoint Inhibitors

Brief summary

Objective response rate (ORR) in cohort A per RECIST 1.1 evaluated by independent central review

Detailed description

Time to response (TTR) per RECIST 1.1 evaluated by independent central review, Duration of response (DOR) per RECIST 1.1 evaluated by independent central review, Disease control rate (DCR) per RECIST 1.1 by independent central review, Progression-free survival (PFS) per RECIST 1.1 by independent central review, ORR in cohort B defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) at any timepoint as determined by independent central review per RECIST 1.1, Overall survival (OS), ORR, TTR, DOR, DCR and PFS per RECIST 1.1 according to local Investigator's review, Change in disease-related symptoms as assessed by the Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI- DRS) questionnaire

Interventions

DRUGCABOMETYX 60 mg film-coated tablets

DRUGCABOMETYX 40 mg film-coated tablets

DRUGCABOMETYX 20 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) in cohort A per RECIST 1.1 evaluated by independent central review	—

Secondary

Measure	Time frame
Time to response (TTR) per RECIST 1.1 evaluated by independent central review, Duration of response (DOR) per RECIST 1.1 evaluated by independent central review, Disease control rate (DCR) per RECIST 1.1 by independent central review, Progression-free survival (PFS) per RECIST 1.1 by independent central review, ORR in cohort B defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) at any timepoint as determined by independent central review per RECIST 1.1, Overall survival (OS), ORR, TTR, DOR, DCR and PFS per RECIST 1.1 according to local Investigator's review, Change in disease-related symptoms as assessed by the Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI- DRS) questionnaire	—

Measure

Time frame

—

Countries

France, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026