Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|