Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of Supplemental Arginine With Chemotherapy and Immunotherapy in Platinum Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer
Sponsor: Rebecca Arend
Summary
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.
Official title: Phase I Study of Supplemental Arginine With Chemotherapy and Immunotherapy in Platinum Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-09
Completion Date
2029-01
Last Updated
2026-08-19
Healthy Volunteers
No
Interventions
Cohort A1
Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + 4.5g daily oral arginine
Cohort A2
Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine
Cohort A3
Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine
A3 Expansion
Continue - Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine
Cohort B1
q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 4.5g daily oral arginine
Cohort B2
q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine
Cohort B3
q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine
B3 Expansion
Continue - q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine
Locations (1)
University of Alabama at Birmingham Womens & Infants Center
Birmingham, Alabama, United States