This is an open-label, Phase 1 clinical study to evaluate the safety, tolerability, PK profiles, and clinical activity of IV and PO arginine supplementation + SOC chemoimmunotherapy regimens in participants with PROC.
Must be at least 18 years of age
ECOG performance status of 0 or 1 (see Appendix A).
Patient must be a candidate for either cohort A or cohort B treatment backbone.
For patients enrolling on treatment cohort A, PD-L1 positivity must be ≥1. Patient's with PD-L1 positivity ≥1% can enroll in cohort B at physician's discretion.
History of allergic reactions contributed to compounds of similar chemical or biological composition to R-Gene 10 or Arginaid.
Patient unwilling/unable to receive daily arginine treatment (IV or oral)
Patients with a history of serologically confirmed HSV-1 or HSV-2 outbreaks
Receiving systemic corticosteroids or have severe comorbities where treatment with corticosteroids may be required.
Parallel
Cohort A1
DrugWeekly paclitaxel + q3w pembrolizumab +/- bevacizumab + 4.5g daily oral arginine
Cohort A2
DrugWeekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine
Cohort A3
DrugWeekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine
A3 Expansion
DrugContinue - Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine
Cohort B1
Drugq3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 4.5g daily oral arginine
Cohort B2
Drugq3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine
Cohort B3
Drugq3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine
B3 Expansion
DrugContinue - q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine
Proportion of patients with serious adverse events
This measures the proportion of patients experiencing serious adverse events
Overall Response Rate
Tumor burden will be evaluated in all participants by the investigator at screening and during/after the intervention period per RECIST 1.1 guidelines. Based on changes in tumor burden, participants will be classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). Participants who are classified as CR or PR will be defined as responders. The overall response rate (ORR) is the proportion of responders out of the evaluable participants. ORR = (PR + CR)/(PR + CR+ SD+ PD)
Duration of Response
Duration of response (DOR) is a time-to-event endpoint measured only in participants who respond to treatment. DOR is the time between response to treatment and disease progression or death. Patients who are lost to follow-up before disease progression or death are censored at time of last contact.
Disease control rate
Tumor burden will be evaluated in all participants by the investigator at screening and during/after the intervention period per RECIST 1.1 guidelines. Based on changes in tumor burden, participants will be classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). Participants who are classified as CR, PR or SD will be defined as having disease control. The disease control rate (DCR) is the proportion of participants with disease control out of the evaluable participants. DCR = (PR + CR + SD)/(PR + CR+ SD+ PD)
Progression Free Survival
Progression free survival (PFS) is a time-to-event endpoint. PFS is the time between start of treatment and the earlier of disease progression or death. Patients who are lost to follow-up before disease progression or death are censored at time of last contact.
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Rebecca Arend
Lead sponsor
University of Alabama at Birmingham
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
