Tremelimumab and Durvalumab in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery

  • STATUS
    Not Recruiting
  • End date
    Jul 30, 2021
  • participants needed
    35
  • sponsor
    M.D. Anderson Cancer Center
Updated on 27 January 2021

Summary

This phase I trial studies the side effects and how well tremelimumab and durvalumab work in treating patients with colorectal cancer that has spread to the liver and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as tremelimumab and durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Description

PRIMARY OBJECTIVES:

I. Assess the safety and feasibility of adding tremelimumab 75 mg intravenously (IV) plus durvalumab (MEDI4736) 1500 mg administered once pre-operatively and 4 cycles of durvalumab 1500 mg IV every 4 weeks for 4 cycles post-operatively in patients who are candidates for resection for colorectal cancer liver metastases.

SECONDARY OBJECTIVES:

I. Explore the changes in various immune parameters, including programmed cell death-1 ligand 1 (PD-L1) and programmed cell death1 (PD-1) expression in the tumor, over treatment and correlate with response and survival with goal of biomarker discovery.

II. Estimate the relapse-free survival (RFS) in all enrolled subjects.

OUTLINE

Patients receive tremelimumab IV over 1 hour and durvalumab IV over 4 hours during week 11. Between weeks 15 and 17, patients undergo liver surgery. Patients then receive durvalumab IV over 1 hour during weeks 21, 25, 29, and 33.

After completion of study treatment, patients are followed up twice a year for 5 years.

Details
Condition Colorectal Cancer, Liver Metastases, Colon Cancer Screening, Colon cancer; rectal cancer, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7, Metastatic Carcinoma in the Liver, Resectable Mass
Treatment laboratory biomarker analysis, MEDI4736, tremelimumab, durvalumab, therapeutic conventional surgery, Liver Resection, Liver Resection
Clinical Study IdentifierNCT02754856
SponsorM.D. Anderson Cancer Center
Last Modified on27 January 2021

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