A Clinical Trial of Durvalumab and Tremelimumab, Administered With Radiation Therapy or Ablation in Patients With Colorectal Cancer
NCT03122509 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2022-07-06
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
Interventions
- DRUG
-
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.
Sponsors & Collaborators
-
MedImmune LLC
collaborator INDUSTRY - collaborator INDUSTRY
-
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Neil Segal, MD, PhD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-24
- Primary Completion
- 2021-04-28
- Completion
- 2021-04-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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