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NCT07772882
Study of Supplemental Arginine With Chemotherapy and Immunotherapy in Platinum Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer
Conditions: Platinum Resistant Ovarian Cancer, Fallopian Tube Cancers, Peritoneal Carcinoma
Sex: Female
Ages: 18 Years – 89 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 24
Sponsor: Rebecca Arend
Location: University of Alabama at Birmingham Womens & Infants Center Birmingham Alabama
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.
Eligibility Criteria
Inclusion Criteria:
1. Must be at least 18 years of age
2. ECOG performance status of 0 or 1 (see Appendix A).
3. 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.
* If PD-L1 positivity is unavailable or is \
Source: ClinicalTrials.gov (NCT07772882). StuddyBuddy aggregates publicly available trial information.
