NCT04108481

Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer

Immunotherapy Combined With Yttrium-90 RadioEmbolization in the Treatment of Colorectal Cancer With Liver Metastases [iRE-C - Clinical Trial]

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will be conducted as a single-center, open-label, Phase I/2 trial to evaluate the feasibility and safety of Yttrium-90 radioembolization (Y90-RE) in combination with a fixed dose of of immunotherapy (durvalumab - 750 mg) in subjects with liver-predominant, metastatic colorectal cancer (mCRC), which is mismatch repair proficient/microsatellite stable (pMMR/MSS).

Detailed 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 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.

Conditions

• Colorectal Cancer Metastatic
• Colon Cancer
• Metastatic Colorectal Cancer
• Rectal Cancer
• Liver Metastasis Colon Cancer
• Colo-rectal Cancer
• Colorectal Adenocarcinoma
• Colorectal Neoplasms
• Liver Metastases
• Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	Durvalumab	Immunotherapy
RADIATION	Yttrium-90 RadioEmbolization	Microscopic radioactive particles (TheraSphere®) will be used for radioembolization to deliver the Y90 drug to the liver

Timeline

• Start date: 2020-10-05
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2019-09-30
• Last updated: 2025-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study