NCT03122509

A Clinical Trial of Durvalumab and Tremelimumab, Administered With Radiation Therapy or Ablation in Patients With Colorectal Cancer

Phase II Study to Assess the Efficacy of Durvalumab (MEDI4736) and Tremelimumab Plus Radiotherapy or Ablation in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety and effectiveness of two investigational drugs (drugs that are not currently approved by the FDA) given in combination with radiation therapy or ablation.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	durvalumab	1500 mg durvalumab via IV infusion
DRUG	tremelimumab	75 mg tremelimumab via IV infusion
RADIATION	Radiotherapy (RT)	Radiotherapy (RT) will be performed using external beam ionizing radiation as standard therapy in accordance with institutional standard practice.
PROCEDURE	ablation	Ablation will be performed percutaneously under image guidance as standard therapy at the discretion of the interventional radiologist in accordance with institutional standard practice.

Timeline

• Start date: 2017-04-24
• Primary completion: 2021-04-28
• Completion: 2021-04-28
• First posted: 2017-04-20
• Last updated: 2022-07-06
• Results posted: 2022-07-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study