NCT07082439

Pembrolizumab and Odetiglucan in Liver Predominant Metastatic Colorectal Adenocarcinoma

Phase II Trial of Pembrolizumab in Combination With Odetiglucan for Patients With Metastatic Colorectal Adenocarcinoma With Liver Predominant Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Colorectal Adenocarcinoma Metastatic in the Liver

Interventions

Type	Name	Description
DRUG	Pembrolizumab	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).
DRUG	Odetiglucan	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).

Timeline

• Start date: 2025-09-10
• Primary completion: 2027-09-01
• Completion: 2029-09-01
• First posted: 2025-07-24
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study