SPICI: Strategic Treatment Pause of First-line Immune Check Point Inhibitor + VEGFR-Tyrosine Kinase Inhibitor in Good or Only One Adverse Prognostic Factor in Intermediate Risk Metastatic Renal Cell Carcinoma (mRCC) With an Objective Response: a Randomised, Non-inferiority Phase III Study

NCT05219318 Phase 3 ACTIVE_NOT_RECRUITING

The purpose of this study is to demonstrate the non-inferiority of treatment pause versus treatment continuation in good or intermediate risk with only one adverse prognostic factor as per IMDC mRCC patients with a confirmed objective response between the end of the 11th month to th end of the 13th month of treatment with PD-1/PD-L1 ICI plus VEGFR-TKI. Tolerance and quality of life of treatment pause with PD-1/PD-L1 ICI + VEGFR-TKI compared to treatment continuation will be reported. In France, its impact on healthcare resource utilization will also be assessed.

Details

Lead sponsor	University Hospital, Bordeaux
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	22
Start date	2023-01-23
Completion	2027-01

Conditions

• Metastatic Renal Cell Carcinoma
• Good or Only One Adverse Prognostic Factor Intermediate Risk Per IMDC Score

Interventions

• Combination PD-1/PD-L1 ICI + VEGFR-TKI
• Treatment pause

Primary outcomes

• Proportion of participants without progression — Up to 12 months after randomisation
  Disease progression at up to 12 months after randomisation will be based on a blinded independent central review (BICR) according to RECIST v1.1 criteria, with tumor assessment performed every 12 weeks during study participation

Countries

France