NCT02754856

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

Pilot Study Assessing the Safety and Tolerability of the Neoadjuvant Use of Tremelimumab (Anti-CTLA-4) Plus Durvalumab (MEDI4736) (Anti-PD-L1) in the Treatment of Resectable Colorectal Cancer Liver Metastases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Carcinoma in the Liver
• Resectable Mass
• Stage IV Colorectal Cancer AJCC v7
• Stage IVA Colorectal Cancer AJCC v7
• Stage IVB Colorectal Cancer AJCC v7

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo liver surgery
BIOLOGICAL	Tremelimumab	Given IV

Timeline

• Start date: 2016-08-29
• Primary completion: 2023-01-30
• Completion: 2023-01-30
• First posted: 2016-04-28
• Last updated: 2024-10-09
• Results posted: 2024-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study