NCT06790706View on ClinicalTrials.gov

IMMUNORARE5: A National Platform of 5 Academic Phase II Trials Coordinated by Lyon University Hospital to Assess the Safety and the Efficacy of the IMMUNOtherapy With Domvanalimab + Zimberelimab Combination in Patients With Advanced RARE Cancers

PHASE2RecruitingINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

November 30, 2028

Study Completion Date

June 30, 2031

Conditions
Peritoneal MesotheliomaGestational Trophoblastic TumorThymoma and Thymic CarcinomaAnaplastic Thyroid CarcinomasGastroenteropancreatic Neuroendocrine TumorCarcinoid Tumor
Interventions
DRUG

DOMVANALIMAB + ZIMBERELIMAB

Patients will be treated with intravenous Domvanalimab at flat dose of 1200 mg + intravenous Zimberelimab at flat dose of 360 mg, administered every 3 weeks (Q3W, one cycle = 3 weeks).

DRUG

DOMVANALIMAB + ZIMBERELIMAB + FOLFOX-4

Patients will be treated with intravenous Domvanalimab at flat doses of 1600 mg + intravenous Zimberelimab at flat dose of 480 mg, administered every 4 weeks (Q4W), together with an induction treatment of intravenous FOLFOX-4 (Oxaliplatin 85 mg/m2 IV, L-folinic acid 200 mg/m2 IV, and fluorouracil 400 mg/m2 IV bolus on Day 1, fluorouracil 2400 mg/m2 IV continuous infusion over 46-48 hours starting on Day 1) given every 2 weeks, for 4 months (one cycle = 4 weeks).

Trial Locations (15)

13009

NOT_YET_RECRUITING

AP-HM, TIMONE Hospital, medical oncology department, Marseille

NOT_YET_RECRUITING

Institut Paoli-Calmettes Marseille, medical oncology department, Marseille

31059

NOT_YET_RECRUITING

ONCOPOLE Claudius Regaud, IUCT-Oncopole, medical oncology department, Toulouse

33076

NOT_YET_RECRUITING

Institut Bergonié, medical oncology department, Bordeaux

34298

NOT_YET_RECRUITING

Institut Régional du Cancer de Montpellier, medical oncology department, Montpellier

35042

NOT_YET_RECRUITING

Centre Eugène Marquis, medical oncology department, Rennes

49055

NOT_YET_RECRUITING

Institut de Cancerologie de l'Ouest , medical oncology department, Angers

59037

NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Lille, medical oncology department, Lille

67200

NOT_YET_RECRUITING

Insitut de Cancérologie Strasbourg Europe, medical oncology department, Strasbourg

69003

RECRUITING

Hospices Civils de Lyon, Medical Oncology Department, Edouard Herriot Hospital, Lyon

69310

RECRUITING

Hospices Civils de Lyon, Medical Oncology Department, Lyon SUD Hospital, Pierre-Bénite

69500

RECRUITING

Hospices Civils de Lyon, Thoracic Oncology Department, Louis Pradel Hospital, Bron

75005

NOT_YET_RECRUITING

Institut Curie, thoracic oncology department, Paris

75020

NOT_YET_RECRUITING

AP-HP, Tenon Hospital, medical oncology department, Paris

94805

NOT_YET_RECRUITING

Institut Gustave Roussy, medical oncology department, Villejuif

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER