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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
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
Conditions
Interventions
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)
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