Actively Recruiting
Pembrolizumab and Odetiglucan in Liver Predominant Metastatic Colorectal Adenocarcinoma
Led by Abramson Cancer Center at Penn Medicine · Updated on 2025-09-22
27
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
Sponsors
A
Abramson Cancer Center at Penn Medicine
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will evaluate the safety and effectiveness of the combination of pembrolizumab and odetiglucan in patients with metastatic colorectal cancer that is predominantly in the liver.
CONDITIONS
Official Title
Pembrolizumab and Odetiglucan in Liver Predominant Metastatic Colorectal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants at least 18 years old at informed consent
- Histologically confirmed metastatic colorectal adenocarcinoma with liver-predominant disease
- No symptomatic lung or bone metastases
- No peritoneal carcinomatosis or significant ascites
- At least one measurable lesion in the liver for response assessment
- Prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and a VEGF inhibitor unless contraindicated
- For KRAS/NRAS/BRAF wild-type cancers, prior treatment with an EGFR inhibitor unless contraindicated
- Tumor mismatch repair proficient or non-microsatellite instability high
- Recovery to Grade 1 or baseline from adverse events of prior therapies
- Written informed consent provided
- Measurable disease based on RECIST 1.1, preferably with an additional lesion suitable for biopsy
- ECOG performance status of 0, 1, or 2 within 7 days before first dose
- Life expectancy of 3 months or longer
- Adequate organ function with specimens collected within 14 days before treatment
- Male participants agree to use contraception during treatment and for 120 days after last dose
- Female participants not pregnant, not breastfeeding, and either not women of childbearing potential or agreeing to contraception during treatment and for 120 days after last dose
You will not qualify if you...
- Women of childbearing potential with positive pregnancy test within 72 hours before first dose
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents like CTLA-4, OX 40, CD137
- Previous treatment with odetiglucan
- Systemic anti-cancer therapy, including investigational agents, within 2 weeks before first dose
- Radiotherapy within 2 weeks before treatment start or ongoing radiation toxicities needing corticosteroids
- Chemoembolization or radioembolization within 6 weeks before enrollment
- Hepatic arterial infusion pump placement
- Live or live-attenuated vaccine within 30 days before first dose
- Investigational agent or device use within 4 weeks or 5 half-lives before first dose
- Immunodeficiency or systemic steroid therapy exceeding 10 mg prednisone daily within 7 days before first dose
- Active malignancies requiring treatment within past 3 years except certain skin cancers
- Active CNS metastases or carcinomatous meningitis unless stable and off steroids for at least 14 days
- Severe hypersensitivity (Grade 3 or higher) to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment within past 2 years except replacement therapy
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Known HIV infection
- Concurrent active Hepatitis B or C infection unless controlled by therapy
- Incomplete recovery from major surgery or ongoing surgical complications
- Clinically significant cardiovascular disease or recent serious cardiac events
- Psychiatric or substance abuse disorders interfering with trial participation
- Pregnant, breastfeeding, or planning to conceive/father children during study and 120 days after last dose
- History of allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Mark O'Hara, MD
CONTACT
W
William Chapin, MD, MSCE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here