Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02754856

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

Stage IV Colorectal Cancer AJCC v7 Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Colorectal Neoplasms
  • 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
Clinical Trial Details
NCT number NCT02754856
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 1
Start date July 28, 2016
Completion date January 30, 2023
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03337087 - Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer Phase 1/Phase 2
Active, not recruiting NCT02738606 - Liver Surgery and Chemotherapy in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery and Lung Metastases That Cannot Be Removed by Surgery Phase 2
Recruiting NCT01365169 - Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients" N/A
Recruiting NCT02600949 - Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer Phase 1
Completed NCT02368886 - Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 2
Active, not recruiting NCT01638533 - Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction Phase 1
Active, not recruiting NCT02873195 - Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 2
Recruiting NCT02997228 - Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study Phase 3
Terminated NCT03300609 - 5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab Phase 3
Active, not recruiting NCT01787500 - Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery Phase 1
Active, not recruiting NCT03087071 - Panitumumab With or Without Trametinib in Treating Patients With Stage IV Colorectal Cancer Phase 2
Completed NCT02292758 - Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery Phase 2
Terminated NCT02757391 - CD8+ T Cell Therapy and Pembrolizumab in Treating Patients With Metastatic Gastrointestinal Tumors Phase 1
Active, not recruiting NCT02888743 - Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer Phase 2
Recruiting NCT05334069 - Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Completed NCT03403634 - Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver Phase 2
Completed NCT03396926 - Pembrolizumab, Capecitabine, and Bevacizumab in Treating Patients With Microsatellite Stable Colorectal Cancer That Is Locally Advanced, Metastatic, or Cannot Be Removed by Surgery Phase 2
Completed NCT03317119 - Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery Phase 1