Trial Summary
What is the purpose of this trial?This trial tests if adding beneficial gut bacteria to a standard cancer treatment can help the immune system fight cancer better. It focuses on patients who are already receiving cancer treatment but are not responding well. The beneficial bacteria may boost the immune response, enhancing the effectiveness of the cancer medicine.
Eligibility Criteria
Adults with advanced solid tumors who are either starting or already on anti-PD-1/PD-L1 immunotherapy, not part of another clinical trial. They must be able to provide tissue samples, stool and blood for analysis, have measurable disease, and a performance status of 0-2. Women must not be pregnant. Those with gastrointestinal disorders affecting absorption cannot join.Inclusion Criteria
Be willing and able to provide stool and blood specimen for analyses at protocol specified time points.
I can take care of myself and am up and about more than half of my waking hours.
I have previously received immunotherapy.
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Exclusion Criteria
Pregnant or planning to get pregnant in the next 6 months.
Any condition that, in the opinion of the Investigator, would interfere with subject safety, or evaluation of the collected specimen and interpretation of study result.
I can swallow pills and don't have gut issues affecting drug absorption, except I may have a colostomy.
Participant Groups
The study is testing MET-4's safety and its ability to integrate into the body when used with standard immune checkpoint inhibitors (ICIs). Participants are divided into groups: one receiving MET-4 plus ICI therapy; others getting only ICI therapy; some who've seen disease progression on ICIs may also receive MET-4.
4Treatment groups
Experimental Treatment
Group I: Group DExperimental Treatment1 Intervention
In group D, eligible subjects with stage III or resected stage IV melanoma who are to start adjuvant ICI, will be randomized in a 1:1 ratio to receive MET-4 in addition to anti-PD1 antibody +/- anti-CTLA4 antibody as per SOC or control group. Patients will be stratified per BRAF mutation status. Subjects will be administered the same MET-4 dose as subjects in groups A, B and C. MET-4 will be initiated as run-in for a minimum of 1 week, and maximum of 2 weeks before ICI administration. MET-4 will be continued until unacceptable toxicity, confirmed PD by RECIST v1.1 or completion of 1 year of ICI, whichever occurs earlier. Subjects in the control arms of groups B, C and D will be treated with ICI therapy as per institution standard of care without MET-4.
Group II: Group CExperimental Treatment1 Intervention
In group C, eligible subjects with advanced solid tumors whom are already on ICI with first unconfirmed PD on evaluation scans per investigator's assessment, will be randomised in a 1:1 ratio to receive MET-4 in addition to the PD-1/PD-L1 inhibitor as per SOC or control group. These subjects must be clinically stable and are to be continued on ICI at the discretion of the investigator. There will be no run-in period for this cohort. Subjects will be administered the same MET-4 dose as subjects in groups A and B.
Group III: Group BExperimental Treatment1 Intervention
Eligible subjects with advanced solid tumors starting ICI will be randomised in a 3:1 ratio stratifying for prior IO exposure, to receive MET-4 together with any approved PD-1/PD-L1 inhibitor as per SOC or control group. There will be a run-in period for subjects in the MET-4 treatment group. Following the run-in period of ICI therapy, subjects will be administered the same MET-4 dose as subjects in group A.
Group IV: Group A: Safety CohortExperimental Treatment1 Intervention
Subjects with advanced solid tumors already on ICI will receive treatment with MET-4 in addition to SOC ICI. MET-4 is administered orally as an initial daily loading dose (5g) of MET-4 over 2 days followed by a daily maintenance dose (1.5g) of MET-4 and will be continued until unacceptable toxicity, progression of disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Princess Margaret Cancer CentreToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
NuBiyotaCollaborator