NCT03101475

Synergism of Immunomodulation and Tumor Ablation

Phase II of Immunotherapy Plus Local Tumor Ablation (RFA or Stereotactic Radiotherapy) in Patients With Colorectal Cancer Liver Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, multi-center early phase II study. This proof of concept study will investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patient with incurable liver metastases from colorectal cancer (CRC) (+/- limited extrahepatic disease) being stable or in partial remission after completion of 4-6 months first line systemic therapy. The primary objective of the study is to show an overall response rate of lesions not treated by ablation/radiotherapy including the extrahepatic lesions (according to iRECIST criteria) higher than 10%. With the continuation of first line systemic treatment, no further responses are expected. Secondary objectives are: * To establish the feasibility and safety of the combined treatment modalities; * To study the impact of the local technique (RFA/Radiotherapy) on the results; * To investigate biomarkers to predict response to the combined treatment

Conditions

• Colorectal Cancer
• Liver Metastases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-23
• Primary completion: 2021-03-03
• Completion: 2022-02-23
• First posted: 2017-04-05
• Last updated: 2022-05-31

Locations

10 sites across 6 countries: Austria, France, Germany, Netherlands, Sweden, Switzerland