Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colo-rectal Cancer
- Colon Cancer
- Colorectal Adenocarcinoma
- Colorectal Cancer Metastatic
- Colorectal Carcinoma
- Colorectal Neoplasms
- Liver Metastases
- Liver Metastasis Colon Cancer
- Metastatic Colorectal Cancer
- Rectal Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Accelerated titration design with an expansion phase once MTD is determined to treat up to a total of 18 patients.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
Description
The purpose of this clinical trial is to find out more about the side effects of immunotherapy with a form of radiation treatment for the cancer in the liver called Yttrium-90 RadioEmbolization (Y90-RE). An immunotherapy drug, durvalumab, will be given intravenously every 2 weeks. Investigators are ...
The purpose of this clinical trial is to find out more about the side effects of immunotherapy with a form of radiation treatment for the cancer in the liver called Yttrium-90 RadioEmbolization (Y90-RE). An immunotherapy drug, durvalumab, will be given intravenously every 2 weeks. Investigators are studying what doses of durvalumab are safe for people in combination with this form of radiation treatment. Patients in this study will receive durvalumab, which is experimental and not approved by the U.S. Food and Drug Administration (FDA) for metastatic colorectal cancer. Microscopic radioactive particles (TheraSphere®) will be used for radioembolization to deliver the Y90 drug to the liver. The number of doses of the immunotherapy drug (range: 2 to 5) will depend on the cohort patients are assigned to. There is no placebo. Everyone on the study is treated with immunotherapy alongside Y90-RadioEmbolization.
Tracking Information
- NCT #
- NCT04108481
- Collaborators
- Biocompatibles UK Ltd
- AstraZeneca
- Investigators
- Principal Investigator: Pashtoon Kasi, MD, MS University of Iowa
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