NCT05219318View on ClinicalTrials.gov

Treatment Pause Versus Treatment Continuation in IMDC Good or Intermediate Risk With Only One Adverse Prognostic Factor in mRCC Patients With an Objective Response at 12 Months of Treatment With PD1/ PDL1 ICIs + VEGFR-Tyrosine Kinase Inhibitors

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

January 23, 2023

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2027

Conditions
Metastatic Renal Cell CarcinomaGood or Only One Adverse Prognostic Factor Intermediate Risk Per IMDC Score
Interventions
DRUG

Combination PD-1/PD-L1 ICI + VEGFR-TKI

The study will enroll patients achieving an objective response beween the end of the 11th month and the end of the 13th month of treatment with the combination PD-1/PD-L1 ICI + VEGFR-TKI as recommended in the Summary of Product Characteristics (SmPC)

OTHER

Treatment pause

Combination regimens discontinuation until progression with the possibility to resume initial combination regimens at progression

Trial Locations (26)

42055

CHU de Saint-Etienne - Service d'Oncologie, Saint-Etienne

97448

CHU de la Réunion Site Sud - Service d'Oncologie, Saint-Pierre

Unknown

CH de la Cote Basque - Service d'Oncologie, Bayonne

CHU de Bordeaux - Service d'Oncologie, Bordeaux

Centre François Baclesse - Service d'Oncologie, Caen

Centre Jean Perrin - Service d'Oncologie, Clermont-Ferrand

AP-HP - Henri Mondor - Service d'Oncologie, Créteil

Centre Georges-François Leclerc - Service d'Oncologie, Dijon

CHU Grenoble Alpes - Service d'Oncologie, Grenoble

CHU de Limoges - Service d'Oncologie, Limoges

Polyclinique de Limoges - Service d'Oncologie, Limoges

Centre Leon Berard - Service d'Oncologie, Lyon

Hospices Civils de Lyon - Service d'Oncologie, Lyon

Institut Paoli-Calmettes - Service d'Oncologie, Marseille

Institut Régional du Cancer - Service d'Oncologie, Montpellier

Centre Antoine Lacassagne - Service d'Oncologie, Nice

AP-HP - Hôpital Européen Georges Pompidou - Service d'Oncologie, Paris

AP-HP - Hôpital Saint Louis - Service d'Oncologie, Paris

CHU de Poitiers - Service d'Oncologie, Poitiers

Centre Eugène Marquis - Service d'Oncologie, Rennes

Institut de cancérologie Strasbourg Europe - Service d'Oncologie, Strasbourg

Hopital Foch - Service d'Oncologie, Suresnes

IUCT Oncopole - Service d'Oncologie, Toulouse

CHU de Tours - Service d'Oncologie, Tours

Institut de Cancérologie de Lorraine - Service d'Oncologie, Vandœuvre-lès-Nancy

Institut Gustave Roussy - Service d'Oncologie, Villejuif

All Listed Sponsors
lead

University Hospital, Bordeaux

OTHER