CARE1: FIRST LINE RANDOMISED STUDY PLATFORM TO OPTIMIZE TREATMENT IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA

Conditions

Metastatic renal cell carcinoma (mRCC)

Brief summary

Overall Survival (OS), Progression-free survival according to RECIST 1.1 NB: Progression-free survival is a co-primary endpoint in the PDL1(-) population, Objective Response Rate (ORR) according to RECIST 1.1, Percentage of patients experiencing a deterioration of ≥3 points on the NFKSI-19 scorein the first twelve months after randomization; Mean Change from Baseline in EQ-VAS andResponse frequencies for the EQ-5D-5L dimensions, Median treatment duration (per treatment), Time to subsequent systemic therapy, defined as the time from the date ofrandomisation to the date of next subsequent systemic therapy. In absence of subsequenttherapy, the data will be censored at the date of last follow-up; Patients dying without receivinga subsequent treatment will be censored at the date of death., Percentage of subjects experiencing grade 3-5 AEs, percentage of patientsexperiencing treatment-related grade 3-5 AEs, Percentage of patients experiencing AE grade≥2leading to the modification of administration of a study drug, Health economic evaluation through the incremental cost per Quality-adjusted life year(QALY), incremental net monetary benefit in the two patient subgroups (PDL1(+) and PDL1(-)respectively)

Related papers

No related papers found yet.

Interventions

DRUGCABOMETYX 40 mg film-coated tablets

DRUGLENVIMA 10 mg hard capsules

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

DRUGAXITINIB SANDOZ 5 mg

DRUGcomprimé pelliculé

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS), Progression-free survival according to RECIST 1.1 NB: Progression-free survival is a co-primary endpoint in the PDL1(-) population, Objective Response Rate (ORR) according to RECIST 1.1, Percentage of patients experiencing a deterioration of ≥3 points on the NFKSI-19 scorein the first twelve months after randomization; Mean Change from Baseline in EQ-VAS andResponse frequencies for the EQ-5D-5L dimensions, Median treatment duration (per treatment), Time to subsequent systemic therapy, defined as the time from the date ofrandomisation to the date of next subsequent systemic therapy. In absence of subsequenttherapy, the data will be censored at the date of last follow-up; Patients dying without receivinga subsequent treatment will be censored at the date of death., Percentage of subjects experiencing grade 3-5 AEs, percentage of patientsexperiencing treatment-related grade 3-5 AEs, Percentage of patients experiencing AE grade≥2leading to the modification of adminis	—

Measure

Time frame

Overall Survival (OS), Progression-free survival according to RECIST 1.1 NB: Progression-free survival is a co-primary endpoint in the PDL1(-) population, Objective Response Rate (ORR) according to RECIST 1.1, Percentage of patients experiencing a deterioration of ≥3 points on the NFKSI-19 scorein the first twelve months after randomization; Mean Change from Baseline in EQ-VAS andResponse frequencies for the EQ-5D-5L dimensions, Median treatment duration (per treatment), Time to subsequent systemic therapy, defined as the time from the date ofrandomisation to the date of next subsequent systemic therapy. In absence of subsequenttherapy, the data will be censored at the date of last follow-up; Patients dying without receivinga subsequent treatment will be censored at the date of death., Percentage of subjects experiencing grade 3-5 AEs, percentage of patientsexperiencing treatment-related grade 3-5 AEs, Percentage of patients experiencing AE grade≥2leading to the modification of adminis

—

Countries

Austria, Czechia, Finland, France, Germany, Greece, Italy, Netherlands

Outcome results

None listed