Recruiting

Pembrolizumab and Odetiglucan for Liver-Predominant Metastatic Colorectal Cancer

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What is being tested

Pembrolizumab

+ Odetiglucan
Drug
Who is being recruted

Colorectal Adenocarcinoma Metastatic in the Liver

Over 18 Years
+45 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorAbramson Cancer Center at Penn Medicine
Study ContactMark O'Hara, MD
Last updated: September 22, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 10, 2025Actual date on which the first participant was enrolled.

This clinical trial focuses on patients with metastatic colorectal cancer, particularly those whose cancer has mainly spread to the liver. The study aims to test the safety and effectiveness of combining two drugs, pembrolizumab and odetiglucan, to see if they can work together to better treat this type of cancer. This research is important because finding more effective treatments for metastatic colorectal cancer could improve outcomes for those affected, potentially leading to longer survival and better quality of life. Participants in this study will receive the treatments as part of the trial to see how the combination affects their cancer. Researchers will monitor the safety of this drug combination and observe how well it works in controlling the growth of the cancer. Through careful observation and data collection, the study aims to determine the potential benefits and any risks associated with using these drugs together for treating liver-predominant metastatic colorectal cancer.

Official TitlePhase II Trial of Pembrolizumab in Combination With Odetiglucan for Patients With Metastatic Colorectal Adenocarcinoma With Liver Predominant Disease 
Principal SponsorAbramson Cancer Center at Penn Medicine
Study ContactMark O'Hara, MD
Last updated: September 22, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
27 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colorectal Adenocarcinoma Metastatic in the Liver
Criteria
17 inclusion criteria required to participate
Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic colorectal adenocarcinoma with liver-predominant disease, defined as liver metastases with
No symptomatic lung or bony metastases
No peritoneal carcinomatosis or clinically significant ascites as determined by the investigator Note: at least 1 measurable lesion must be present in the liver to assess response. It is preferable to have at least 1 other lesion present in the liver which can be biopsied. Measurable lesions chosen as target lesions in the liver should not be biopsied if it can be avoided
Patient must have received prior treatment with a fluoropyrimidine, oxaliplatin, irinotecan, and a VEGF inhibitor (e.g., bevacizumab), unless contraindicated

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28 exclusion criteria prevent from participating
WOCBP who has a positive urine pregnancy test within 72 hours prior to receiving the first dose of study medication (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. If the serum pregnancy test is negative, then the participant will be deemed eligible on this criterion
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
Has previous treatment with odetiglucan
Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to first dose of study treatment

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Study Objectives
Primary Objectives

Proportion of patients with best response as complete response (CR) or PR (partial response) using RECIST v. 1.1.
Secondary Objectives

Proportion of patients with best response of CR or PR as assessed by iRECIST.

Proportion of patients with best response of CR or PR as assessed by iRECIST using only target lesions in the liver.

Time from first CR or PR by iRECIST to disease progression or death, whichever occurs first. Censoring will occur at the time of last patient contact if lost to follow-up, or at the time of data cutoff.

Proportion of patients with PR, CR, or stable disease (SD) by iRECIST as best response.

Time from enrollment to disease progression by iRECIST or death, whichever occurs first. Censoring will occur at the time of last patient contact if lost to follow-up, or at the time of data cutoff.

Time from enrollment to death. Censoring will occur at the time of last patient contact if lost to follow-up, or at the time of data cutoff.

Toxicity rates will be assessed as an ordinal measure (e.g., Grade 1 pneumonitis, Grade 2 pneumonitis, etc.) using CTCAE v. 5.0. Toxicity rates will be summarized as a proportion of patients experiencing each toxicity.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Abramson Cancer Center at the University of PennsylvaniaPhiladelphia, United StatesSee the location
Recruiting
One Study Center