Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07772882
PHASE1

Study of Supplemental Arginine With Chemotherapy and Immunotherapy in Platinum Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer

Sponsor: Rebecca Arend

View on ClinicalTrials.gov

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

DRUG

Cohort A1

Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + 4.5g daily oral arginine

DRUG

Cohort A2

Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine

DRUG

Cohort A3

Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine

DRUG

A3 Expansion

Continue - Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine

DRUG

Cohort B1

q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 4.5g daily oral arginine

DRUG

Cohort B2

q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine

DRUG

Cohort B3

q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine

DRUG

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