Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05219318
PHASE3

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2023-01-23

Completion Date

2027-01

Last Updated

2025-06-04

Healthy Volunteers

No

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

Locations (26)

CH de la Cote Basque - Service d'Oncologie

Bayonne, France

CHU de Bordeaux - Service d'Oncologie

Bordeaux, France

Centre François Baclesse - Service d'Oncologie

Caen, France

Centre Jean Perrin - Service d'Oncologie

Clermont-Ferrand, France

AP-HP - Henri Mondor - Service d'Oncologie

Créteil, France

Centre Georges-François Leclerc - Service d'Oncologie

Dijon, France

CHU Grenoble Alpes - Service d'Oncologie

Grenoble, France

CHU de Limoges - Service d'Oncologie

Limoges, France

Polyclinique de Limoges - Service d'Oncologie

Limoges, France

Centre Leon Berard - Service d'Oncologie

Lyon, France

Hospices Civils de Lyon - Service d'Oncologie

Lyon, France

Institut Paoli-Calmettes - Service d'Oncologie

Marseille, France

Institut Régional du Cancer - Service d'Oncologie

Montpellier, France

Centre Antoine Lacassagne - Service d'Oncologie

Nice, France

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

Paris, France

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

Paris, France

CHU de Poitiers - Service d'Oncologie

Poitiers, France

Centre Eugène Marquis - Service d'Oncologie

Rennes, France

CHU de Saint-Etienne - Service d'Oncologie

Saint-Etienne, France

CHU de la Réunion Site Sud - Service d'Oncologie

Saint-Pierre, France

Institut de cancérologie Strasbourg Europe - Service d'Oncologie

Strasbourg, France

Hopital Foch - Service d'Oncologie

Suresnes, France

IUCT Oncopole - Service d'Oncologie

Toulouse, France

CHU de Tours - Service d'Oncologie

Tours, France

Institut de Cancérologie de Lorraine - Service d'Oncologie

Vandœuvre-lès-Nancy, France

Institut Gustave Roussy - Service d'Oncologie

Villejuif, France