Study Summary
This trial is testing a combination of immunotherapy and targeted therapy as a treatment for colorectal cancer that has spread to the liver and can be removed by surgery.
Eligible Conditions
- Stage IV Colorectal Cancer
- Liver Cancer
- Stage IVC Colorectal Cancer
- Stage IVB Colorectal Cancer
- Stage IVA Colorectal Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 13 Secondary · Reporting Duration: Up to 2 years
Up to 1 month
Proportion of participants with an R0 resection
Proportion of participants with perioperative complications
Up to 1 year
Complete response (CR) rate for patients receiving Pembrolizumab
Incidence of treatment-related adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Objective response rate (ORR)
Objective response rate (ORR) to leucovorin calcium (calcium folinate), 5-fluorouracil, and oxaliplatin (FOLFOX)
Partial response (PR) rate for patients receiving Pembrolizumab
Pathologic response rate
Progression-free survival (PFS) per RECIST 1.1
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.
R0 resection rate
Up to 2 years
Median Relapse-free survival (RFS) per RECIST 1.1
Proportion of participants with events of clinical interest (ECIs)
Proportion of participants with treatment-related, adverse events
Neoplasms
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
Trial Design
1 Treatment Group
Treatment (vactosertib, pembrolizumab, surgery)
1 of 1
Experimental Treatment
19 Total Participants · 1 Treatment Group
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2
Treatment (vactosertib, pembrolizumab, surgery)Experimental Group · 3 Interventions: Hepatectomy, Pembrolizumab, Vactosertib · Intervention Types: Procedure, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hepatectomy
2020
Completed Phase 2
~1970
Pembrolizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,676 Previous Clinical Trials
4,955,751 Total Patients Enrolled
1 Trials studying Stage IV Colorectal Cancer
49 Patients Enrolled for Stage IV Colorectal Cancer
University of California, San FranciscoLead Sponsor
2,283 Previous Clinical Trials
11,577,726 Total Patients Enrolled
1 Trials studying Stage IV Colorectal Cancer
2 Patients Enrolled for Stage IV Colorectal Cancer
MedPacto, Inc.Industry Sponsor
9 Previous Clinical Trials
400 Total Patients Enrolled
Chloe Atreya, MD, PhDLead Sponsor
Chloe Atreya, MD, Ph.D.Principal InvestigatorUniversity of California, San Francisco
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have histologically or cytologically confirmed colorectal cancer with liver metastases and may also have extrahepatic metastases (e.g., pulmonary), provided all other eligibility criteria are met; in the Neoadjuvant Arm, primary tumor can be present in situ.
You have been treated with oxaliplatin-based chemotherapy previously.
FOLFOX or capecitabine combined with oxaliplatin (CapeOx) do not need to be an antecedent treatment for this study.
Chemotherapy is permissible in this study, provided a mAb (bevacizumab, cetuximab or panitumumab) has been administered and the final cycle of chemotherapy omits the antibody prior to pembrolizumab.
You are deemed an eligible subject by the Multidisciplinary GI Tumor Board for liver biopsy and removal (with or without ablation) of metastatic deposits.
You are able and willing to provide written consent/assent for the trial, with an optional additional agreement to participate in Future Biomedical Research.
You are at least 18 years old on the day you sign your informed consent.
You have a quantifiable form of illness according to RECIST 1.1, including lesions in areas that have been exposed to radiation (Neoadjuvant Arm Only) if progression has occurred.
You are willing to provide a tissue sample from a freshly-procured core or excisional biopsy of the tumor lesion
You have an ECOG Performance Scale score of 0 or 1.
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Conditions
Cancer Related
Treatments