NCT04396223View on ClinicalTrials.gov

Avelumab and Methotrexate in in Low-risk Gestational Trophoblastic Neoplasias as First Line Treatment

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

February 12, 2020

Primary Completion Date

April 12, 2025

Study Completion Date

October 12, 2028

Conditions
Gestational Trophoblastic Neoplasias (GTN)
Interventions
DRUG

Avelumab Injection

Avelumab administration at 800mg a 1 hour IV infusion once every 14 days during 4 months ½ (median)

DRUG

Methotrexate 1 GM Injection

methotrexate administration at 1mg/kg/day during 4 months ½ (median)

Trial Locations (9)

13000

NOT_YET_RECRUITING

Institut Paoli-Calmettes, Marseille

14000

NOT_YET_RECRUITING

Centre François Baclesse, Caen

31000

RECRUITING

Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse

33000

RECRUITING

Institut Bergonié, Bordeaux

35000

RECRUITING

Centre Eugène Marquis, Rennes

59000

NOT_YET_RECRUITING

Centre Oscar Lambret, Lille

69495

RECRUITING

Centre Hospitalier Lyon Sud, Pierre-Bénite

06000

RECRUITING

Centre Antoine Lacassagne, Nice

Unknown

RECRUITING

Assistance Publique Hôpitaux de Paris, Paris

All Listed Sponsors
collaborator

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

Hospices Civils de Lyon

OTHER