Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months (NiCOL)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

November 27, 2017

Primary Completion Date

October 30, 2020

Study Completion Date

March 7, 2022

Conditions
Cervical CancerLocally Advanced Cervical Cancer
Interventions
DRUG

Nivolumab Injection

2 possible doses : flat dose 240 mg q2 weeks or 1mg/kg q2 weeks

DRUG

Cisplatin

40 mg/m2, once a week during radiotherapy

RADIATION

radiotherapy

"Intensity-modulated radiation therapy (including volumetric-modulated arc therapy and tomography) will be used. A dose of 45 Gy will be delivered to the pelvis in 25 fractions of 1.8 Gy using a 6-MV photon energy.~An additional dose of 54 Gy in 25 fractions of 2.16 Gy may be delivered to invaded lymph nodes using SIB-IMRT.~An additional lateral pelvic dose may be delivered if coverage of the target volumes is judged insufficient. The volumes, doses and techniques will be those usually used in each center."

Trial Locations (3)

9220

Institut Curie Hopital René Huguenin, Saint-Cloud

75005

Institut Curie, Paris

75015

Hopital Européen Georges Pompidou, Paris

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Institut Curie

OTHER