Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer

PHASE1TerminatedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

June 1, 2018

Primary Completion Date

July 15, 2022

Study Completion Date

July 15, 2022

Conditions
Recurrent Gynecological CancerMetastatic Cervical CancerMetastatic Ovarian CancerMetastatic Vaginal CancerMetastatic Vulvar CancerMetastatic Endometrial CancerRecurrent Cervical CarcinomaRecurrent Ovarian CarcinomaRecurrent Vaginal CancerRecurrent Vulvar CancerRecurrent Endometrial Cancer
Interventions
DRUG

Durvalumab

Durvalumab is given by intravenous infusion every 4 weeks for a maximum of 13 doses over 52 weeks. One cycle is defined as every 4 weeks. Each infusion will take approximately 1 hour.

DRUG

Tremelimumab

Tremelimumab is given by intravenous infusion every 4 weeks for a maximum of 4 doses over 16 weeks. One cycle is defined as every 4 weeks. If receiving both durvalumab and tremelimumab for the first 4 cycles, they will be given on the same day. Each infusion will take approximately 1 hour

RADIATION

Radiation Therapy

Radiation treatment will begin on the same day as the first immunotherapy infusion or on the following day. The radiation treatment course is either 1 day or 5 days.

Trial Locations (2)

02115

Brigham and Women's Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Dana-Farber Cancer Institute

OTHER

NCT03277482 - Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer | Biotech Hunter | Biotech Hunter