Clinical Trials Logo

Clinical Trial Summary

This phase I/II trial studies the side effects and best dose of cetuximab when given together with pembrolizumab in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body (metastatic) or that cannot be removed by surgery. Monoclonal antibodies, such as cetixumab and pembrolizumab, may block tumor growth in different ways by targeting certain cells.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To estimate the objective response rate of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab. II. To estimate the 6-month progression free survival (PFS) rate of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab. III. To examine the adverse event profile of combining pembrolizumab and cetuximab. SECONDARY OBJECTIVES: I. To examine the PFS of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab. II. To determine the objective response rate by immune-related response criteria (irRC) of patients with metastatic colorectal cancer. III. To examine the overall survival of patients with metastatic colorectal cancer treated with pembrolizumab and cetuximab. EXPLORATORY OBJECTIVES: I. Identify tumor and peripheral blood biomarkers of response and/or resistance to the study treatment. OUTLINE: Patients receive cetuximab intravenously (IV) over 120 minutes on day 1, 8, and 15 (as monotherapy for cycle 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression. After completion of the study treatment, patients are followed up every 3 months for up to 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02713373
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Completed
Phase Phase 1/Phase 2
Start date August 5, 2016
Completion date July 20, 2021

See also
  Status Clinical Trial Phase
Completed NCT00545545 - Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma Phase 1/Phase 2
Not yet recruiting NCT05518032 - Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC) 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
Completed NCT01522820 - Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors Phase 1
Recruiting NCT04017650 - Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer Phase 1/Phase 2
Active, not recruiting NCT01638533 - Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction Phase 1
Recruiting NCT06307548 - Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer Phase 1/Phase 2
Active, not recruiting NCT02873195 - Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 2
Completed NCT03095781 - Pembrolizumab and XL888 in Patients With Advanced Gastrointestinal Cancer Phase 1
Not yet recruiting NCT05883683 - Molecular Study and Precision Medicine for Colorectal Cancer
Completed NCT02973672 - Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas Phase 1/Phase 2
Terminated NCT02650635 - TLR8 Agonist VTX-2337 and Cyclophosphamide in Treating Patients With Metastatic, Persistent, Recurrent, or Progressive Solid Tumors Phase 1
Terminated NCT02508077 - FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer Phase 2
Not yet recruiting NCT03823079 - Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia Phase 2
Active, not recruiting NCT04616183 - LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer Phase 1/Phase 2
Active, not recruiting NCT02188264 - Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer Phase 1
Active, not recruiting NCT02465060 - Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Phase 2
Completed NCT03087591 - APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery Phase 1
Completed NCT03403634 - Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver Phase 2