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

Over 18 Years
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, MDMore contacts
Last updated: December 11, 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 
NCT07082439
Principal SponsorAbramson Cancer Center at Penn Medicine
Study ContactMark O'Hara, MDMore contacts
Last updated: December 11, 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.
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.
Criteria

Inclusion Criteria: * 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. * Patients with KRAS/NRAS/BRAF wild-type cancers must also have received an EGFR inhibitor (e.g., cetuximab or panitumumab) in addition to the aforementioned therapies, unless contraindicated. * Patients who experienced disease recurrence within 6 months of oxaliplatin-containing adjuvant therapy will qualify as having received an oxaliplatin-containing regimen in the metastatic setting. * Tumor must have documented mismatch repair proficiency (MMR proficient) by immunohistochemistry or not microsatellite instability high(non-MSI-H) by PCR. * Participants who have adverse events due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy or persistent alopecia are eligible. * The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. * Have measurable disease based on RECIST 1.1 with at least one measurable lesion in the liver. It is preferable that one additional viable lesion in the liver that could be safely biopsied is also present, but not required for inclusion. Lesions chosen as target lesions in the liver should not be biopsied if possible. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention. * Have a life expectancy of 3 months or greater as assessed by the investigator * Have adequate organ function. Specimens must be collected within 14 days prior to the start of study intervention. * Male participants: A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment. Exclusion Criteria: * 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. * Has received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation-related toxicities requiring corticosteroids. * Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted. * Has undergone treatment chemoembolization or radioembolization within 6 weeks prior to enrollment on the study * Has undergone hepatic arterial infusion pump placement * Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. * Has received an investigational agent or has used an investigational device within the shorter of 4 weeks or 5 half-lives of the first dose of study intervention administration. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. * Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. * Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid) * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has an active infection requiring systemic therapy. * Has a known history of Human Immunodeficiency Virus (HIV) infection * Note: No HIV testing is required unless mandated by local health authority. * Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Hepatitis B and C screening tests are not required unless the participant has a known history of HBV and HCV infection. Participants may be eligible if the following criteria are met (18a and/or 18b). * Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, have undetectable HBV viral load prior to initiation of study therapy, and should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention * Participants with history HCV infection are eligible if HCV viral load is undetectable at screening and have completed curative anti-viral therapy at least 4 weeks prior to randomization * Has not adequately recovered from major surgery or has ongoing surgical complications. * Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator. * Has a clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome within ≤ 6 months prior to start of study treatment, symptomatic or uncontrolled arrhythmia, congestive heart failure, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. * Has had an allogenic tissue/solid organ transplant.


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

Pembrolizumab 200 mg intravenous administration on day 1 of each 3-week cycle until disease progression, unacceptable toxicity or participant withdrawal. Participants who complete study intervention after 2 years of pembrolizumab and odetiglucan without disease progression and subsequently experience disease progression while off of treatment are eligible for up to 1 year of additional pembrolizumab and odetiglucan (second course).

Odetiglucan 4 mg/kg intravenous administration on day 1 of each 3-week cycle until disease progression, unacceptable toxicity or participant withdrawal. Participants who complete study intervention after 2 years of pembrolizumab and odetiglucan without disease progression and subsequently experience disease progression while off of treatment are eligible for up to 1 year of additional pembrolizumab and odetiglucan (second course).
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
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