Pembrolizumab and Odetiglucan in Liver Predominant Metastatic Colorectal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pembrolizumab
- Odetiglucan
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
Abramson Cancer Center at Penn Medicine
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov