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Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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]

NCT04108481•University of Iowa

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years
•Histological or cytological confirmation of colorectal cancer with metastasis to the liver. Mismatch repair or microsatellite instability status of the tumor needs to be known. Tumors need to be mismatch repair proficient (for mismatch repair deficient tumors immunotherapy is already approved).
•Patient must have at least 1 liver lesion measurable as defined in the protocol
•Must have liver metastases and be appropriate for treatment with Y-90 radioembolization therapy as determined by the treating medical oncologist and interventional radiologist/oncologist, and nuclear medicine physician(s). NOTE: the goal of therapy is safety and parenchymal sparing. Typically, since the treatment is personalized, the goal is to have at least 30% liver parenchymal sparing post treatment.
•Must have a metastatic focus amendable to biopsy. It is permissible to use same or alternative lesion for biopsy for assessment for tumor response and changes in microenvironment (mandatory pre- and post-Y90-RE biopsy).
•At least 2 but no more than 3 lines of therapy allowed in metastatic setting. These include at least treatment with a fluoropyrimidine, oxaliplatin, and/or irinotecan-based therapy, an anti-VEGF therapy and, if RAS wild-type, an anti-EGFR therapy, unless deemed intolerant or not suitable by the treating oncologist. NOTE: adjuvant and/or maintenance chemotherapy does not count as an additional line of therapy. (Patients with more than 3 lines of therapy are at risk for liver disease from prior systemic therapies and would not be reasonable candidates for Y90-RE).
•ECOG Performance Status (PS) 0 or 1.
•Negative serum pregnancy test done ≤7 days prior to registration, for persons of childbearing potential only.
•Females of childbearing potential (FOCBP), must use appropriate method(s) of contraception. FOCBP are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Additionally, FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with durvalumab plus 5 half-lives of durvalumab (13 weeks) plus 30 days (duration of ovulatory cycle) for a total of 17 weeks post-treatment completion (details in appendix).
•Men who are sexually active with FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with durvalumab plus 5 half-lives of durvalumab plus 90 days (duration of sperm turnover) for a total of 25 weeks post-treatment completion (details in appendix).
+6 more criteria

Exclusion Criteria

•Any of the following laboratory abnormalities:
•* Hemoglobin \<8.0 g/dL
•* Absolute neutrophil count (ANC) \<1500/mm3
•* Platelet count \<100,000/mm3
•* Total bilirubin \>1.5 x ULN (except in subjects with Gilbert Syndrome, who cannot have a total bilirubin \> 3.0 mg/dL)
•* Alanine aminotransferase (ALT) and Aspartate transaminase (AST) \>2.5 x ULN
•* Serum creatinine \> 1.5 x ULN OR
•* Calculated creatinine clearance \<30 ml/min using the Cockcroft-Gault formula
•Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
•* Pregnant persons
+18 more criteria

Locations (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Key Dates

Start Date

October 5, 2020

Primary Completion Date

November 17, 2023

Completion Date

November 17, 2023

Last Updated

March 28, 2025

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer MetastaticColon CancerMetastatic Colorectal CancerRectal CancerLiver Metastasis Colon CancerColo-rectal CancerColorectal AdenocarcinomaColorectal NeoplasmsLiver MetastasesColorectal Carcinoma

Interventions

Durvalumab

DRUG

Yttrium-90 RadioEmbolization

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

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