A BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

May 31, 2017

Primary Completion Date

February 15, 2021

Study Completion Date

February 15, 2021

Conditions
Clear Cell Metastatic Renal Cell Carcinoma
Interventions
DRUG

Nivolumab

"For Arms 1A and 4A:~Nivolumab alone administered IV over 60 minutes at 240 mg every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.~For Arms 1B, 2B, 3B and 4B:~Nivolumab administered IV over 60 minutes at 3 mg/kg combined with ipilimumab administered IV over 30 minutes at 1 mg/kg every 3 weeks for 4 doses followed by nivolumab administered IV over 60 minutes at 240 mg every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.~Starting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference."

DRUG

Ipilimumab

"For Arms 1B, 2B, 3B and 4B:~Ipilimumab administered IV over 30 minutes at 1 mg/kg every 3 weeks combined with Nivolumab administered IV over 60 minutes at 3 mg/kg for 4 doses until disease progression, unacceptable toxicity or other reasons specified in the protocol."

DRUG

Pazopanib

"For Arms 2C and 3C (TKI pazopanib or sunitinib):~Pazopanib 800 mg orally QD until disease progression, unacceptable toxicity or other reasons specified in the protocol"

DRUG

Sunitinib

"For Arms 2C and 3C (TKI pazopanib or sunitinib):~Sunitinib 50 mg orally QD until disease progression, unacceptable toxicity or other reasons specified in the protocol"

Trial Locations (16)

13009

Institut Paoli Calmettes (IPC), Marseille

14000

Centre Francois Baclesse, Caen

30029

Institut de Cancérologie du Gard - CHU Caremeau, Nîmes

31059

Institut Claudius Regaud, Toulouse

33075

Hôpital Saint André, CHU de Bordeaux, Bordeaux

35042

Centre Eugene Marquis, Rennes

37000

CHU Bretonneau, Tours

59000

Centre OSCAR LAMBRET LILLE, Lille

67000

Hôpitaux universitaires de Strasbourg, Strasbourg

69310

Centre Hospitalier Lyon Sud - Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite

75014

Institut Mutualiste Montsouris, Paris

75015

Hôpital Européen Georges Pompidou, Paris

75679

Hôpital Cochin, Paris

92151

Hopital Foch, Suresnes

94000

CHU Henri-Mondor, Créteil

06100

Centre Antoine Lacassagne, Nice

All Listed Sponsors
lead

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

OTHER

NCT02960906 - A BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer | Biotech Hunter | Biotech Hunter