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
This trial does not accept healthy volunteersQualifiers
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
Sum of diameters of RECIST measurable lesions (>1cm in diameter for extra-nodal metastases or >1.5cm in short axis for nodal metastases) outside of the liver is less than the sum of diameters of RECIST measurable lesions within the liver per the investigator's assessment.
Disqualifiers
Liver metastases occupy > 50% of liver parenchmyma by volume per the investigator's assessment.
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
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab
DrugPembrolizumab 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
DrugOdetiglucan 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).
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: Pembrolizumab and OdetiglucanExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Overall response rate (ORR)
Proportion of patients with best response as complete response (CR) or PR (partial response) using RECIST v. 1.1.
Time frame
Up to 2 yearsSecondary outcomes
1
ORR iRECIST
Proportion of patients with best response of CR or PR as assessed by iRECIST.
Time frame
Up to 2 years.2
ORR Liver by iRECIST
Proportion of patients with best response of CR or PR as assessed by iRECIST using only target lesions in the liver.
Time frame
Up to 2 years.3
Duration of response
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.
Time frame
From date of first CR or PR by iRECIST until disease progression or death, whichever comes first, assessed up to 4 years.4
Disease control rate
Proportion of patients with PR, CR, or stable disease (SD) by iRECIST as best response.
Time frame
Up to 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov