Synergism of Immunomodulation and Tumor Ablation

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

November 23, 2018

Primary Completion Date

March 3, 2021

Study Completion Date

February 23, 2022

Conditions
Colorectal CancerLiver Metastases
Interventions
DRUG

Durvalumab (MEDI4736)

Durvalumab (MEDI4736) 1500mg Q4W in combination with tremelimumab for up to 4 doses/cycles, followed by durvalumab (MEDI4736) 1500mg Q4W for up to a maximum of 8 months with the last administration on week 48 unless there is unacceptable toxicity.

DRUG

Tremelimumab

Tremelimumab (75 mg IV Q4W) in combination with durvalumab (MEDI4736) (1500mg Q4W) for up to 4 doses/cycles

RADIATION

Sterotactic body radiation therapy (SBRT)

delivered in 3 fractions of 10 Gy over 1 week starting 8 to 14 days after first dose of immunotherapy

OTHER

Radiofrequency ablation (RFA)

performed percutaneously under CT, MRI or sonographic guidance 8 to 14 days after start of immunotherapy

Trial Locations (10)

Unknown

Medical University Vienna - General Hospital AKH, Vienna

Institut Bergonie, Bordeaux

Universitaetsklinikum Carl Gustav Carus, Dresden

Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden, Leipzig

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam

Radboud University Medical Center Nijmegen, Nijmegen

Karolinska University Hospital - Karolinska Institutet - Danderyds Hospital, Stockholm

Inselspital, Bern

Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie, Geneva

UniversitaetsSpital Zurich, Zurich

All Listed Sponsors
lead

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

NCT03101475 - Synergism of Immunomodulation and Tumor Ablation | Biotech Hunter | Biotech Hunter