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

NCT07772882 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

  • Platinum Resistant Ovarian Cancer
  • Fallopian Tube Cancers
  • Peritoneal Carcinoma

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

Sponsors & Collaborators

  • Rebecca Arend

    lead OTHER

Principal Investigators

  • Rebecca C Arend, MD · The University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-10-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07772882 on ClinicalTrials.gov