Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery
|ClinicalTrials.gov Identifier: NCT03844750|
Recruitment Status : Suspended (Pending Amendment)
First Posted : February 18, 2019
Last Update Posted : May 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Malignant Neoplasm in the Liver Stage IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8||Procedure: Hepatectomy Biological: Pembrolizumab Drug: FOLFOX regimen||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Preoperative Immunotherapy in Patients With Colorectal Cancer and Resectable Hepatic Metastases|
|Actual Study Start Date :||July 12, 2019|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2024|
Experimental: Treatment (FOLFOX, pembrolizumab, surgery)
Patients receive between 4 and 8 FOLFOX treatments, based on the treating physician's opinion. Approximately 2 weeks after the last dose of FOLFOX, patients receive pembrolizumab IV over 30 minutes on day 1. About 2 weeks later, patients undergo hepatic resection.
Undergo liver resection.
Other Name: Liver Resection
Drug: FOLFOX regimen
- Proportion of patients with a >= 2-fold increase in the tumor-infiltrating CD3+ T cells per unit area (5 high power fields) in post- versus pre pembrolizumab treatment tumor specimens. [ Time Frame: Up to 1 year ]Tumor-infiltrating immune cells (TIICs) will be analyzed by immunohistochemistry (IHC) in pre- and post-pembrolizumab treatment tumor specimens. The proportion of patients with a >= 2-fold increase (from pre- to post-treatment) in the number of TIICs per unit area (5 high power fields) will be calculated.
- Incidence of treatment-related adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Up to 1 year ]Adverse events (AEs) will be analyzed including but not limited to all AEs, serious (S)AEs, and fatal AEs. Furthermore, specific immune-related AEs (irAEs) will be collected and designated as immune-related events of clinical interest (ECIs). The study will use descriptive statistics to report on the safety/toxicity.
- Objective response rate (ORR) to leucovorin calcium (calcium folinate), 5-fluorouracil, and oxaliplatin (FOLFOX) [ Time Frame: Up to 1 year ]Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Partial response (PR) rate to pembrolizumab [ Time Frame: Up to 1 year ]Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Complete response (CR) rate to pembrolizumab [ Time Frame: Up to 1 year ]Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Pathologic response rate [ Time Frame: Up to 1 year ]The study will use descriptive statistics to report on pathologic response.
- R0 resection rate [ Time Frame: Up to 1 year ]The study will use descriptive statistics to report on R0 resection rate.
- Progression-free survival (PFS) per RECIST 1.1 [ Time Frame: At 1 year ]The study will use descriptive statistics to report on PFS.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844750
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Chloe Atreya, MD, Ph.D.||University of California, San Francisco|