Pembrolizumab and Odetiglucan in Liver Predominant Metastatic Colorectal Adenocarcinoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT07082439
Phase
PHASE2
Status
Recruiting
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Conditions

  • Colorectal Adenocarcinoma Metastatic in the Liver

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    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 — DRUG
    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 Details

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.

Key Dates

Start date
Sep 10, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab and Odetiglucan

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center at the University of PennsylvaniaPhiladelphiaPennsylvania19104
Jennifer Walsh
William Chapin, MD, MSCE (PRINCIPAL_INVESTIGATOR)

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By research site
Abramson Cancer Center at the University of Pennsylvania· Philadelphia, PA

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