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

NCT07772882 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IRB-300016887 (UAB 2667)O'Neal Cancer Center
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with serious adverse events

  This measures the proportion of patients experiencing serious adverse events

  Baseline through year 2

Secondary Outcomes (5)

• Overall Response Rate

  Baseline through year 2

• Duration of Response

  Baseline through year 2

• Disease control rate

  Baseline through year 2

• Progression Free Survival

  Baseline through year 2

• Overall Survival

  Baseline through year 2

Study Arms (2)

CPS>1, physician's choice for Cohort A or Cohort B

EXPERIMENTAL

Cohort A: 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 previous regimen OR Cohort B: 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 previous regimen

Drug: Cohort A1; Drug: Cohort A2; Drug: Cohort A3; Drug: A3 Expansion; Drug: Cohort B1; Drug: Cohort B2; Drug: Cohort B3; Drug: B3 Expansion

CPS<1, must be assigned to Cohort B

EXPERIMENTAL

Cohort B: 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 previous regimen

Drug: Cohort B1; Drug: Cohort B2; Drug: Cohort B3; Drug: B3 Expansion

Interventions

Cohort A1 DRUG

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

Also known as: Oral Arginine (Arginaid®), Pembrolizumab, bevacizumab, Paclitaxel

CPS>1, physician's choice for Cohort A or Cohort B

Cohort A2 DRUG

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

Also known as: IV Arginine (R-Gene® 10), Pembrolizumab, bevacizumab, paclitaxel

CPS>1, physician's choice for Cohort A or Cohort B

Cohort A3 DRUG

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

Also known as: IV arginine, Oral Arginine (Arginaid®), Pembrolizumab, bevacizumab, paclitaxel

CPS>1, physician's choice for Cohort A or Cohort B

A3 Expansion DRUG

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

Also known as: IV arginine, Oral Arginine (Arginaid®), Pembrolizumab, bevacizumab, paclitaxel

CPS>1, physician's choice for Cohort A or Cohort B

Cohort B1 DRUG

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

Also known as: Oral Arginine (Arginaid®), IV bevacizumab, IV Pembrolizumab, oral phosphamide

CPS<1, must be assigned to Cohort B; CPS>1, physician's choice for Cohort A or Cohort B

Cohort B2 DRUG

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

Also known as: IV arginine, IV bevacizumab, IV pembrolizumab, oral phosphamide

CPS<1, must be assigned to Cohort B; CPS>1, physician's choice for Cohort A or Cohort B

Cohort B3 DRUG

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

Also known as: IV arginine, Oral Arginine (Arginaid®), oral phosphamide, IV pembrolizumab, IV bevacizumab

CPS<1, must be assigned to Cohort B; CPS>1, physician's choice for Cohort A or Cohort B

B3 Expansion DRUG

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

Also known as: IV arginine, Oral Arginine (Arginaid®), oral phosphamide, IV pembrolizumab, IV bevacizumab

CPS<1, must be assigned to Cohort B; CPS>1, physician's choice for Cohort A or Cohort B

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• If PD-L1 positivity is unavailable or is \<1%, patients can only enroll on treatment cohort B.
• Patients must have high-grade serous or endometrioid histology
• Recovery to baseline or ≤ Grade 1 CTCAE v.5.0 from toxicities related to the prior therapy, unless after discussion with the medical monitor the AE(s) are deemed clinically non-significant and/or stable on supportive therapy
• Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent
• Patients must have adequate hematologic, liver and kidney functions prior to lead-in chemotherapy defined as:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109 /L (1,500/μL)
• Platelet count ≥ 100 x 109 /L (100,000/μL) without platelet transfusion in the prior 10 days
• Hemoglobin ≥ 9.0 g/dL
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
• Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN)

You may not qualify if:

• 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.
• Actively treated auto-immune disease.
• Taking medications that interfere with the urea cycle such as valproate or xanthine oxidase inhibitors.
• Current intercurrent illnesses including active infection, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmias.
• Patients with history of Peptic Ulcer Disease
• Contraindications to receive standard of care treatment backbone with either paclitaxel, bevacizumab, pembrolizumab, or cyclophosphamide.

Sponsors & Collaborators

• Rebecca Arend: lead

Study Sites (1)

University of Alabama at Birmingham Womens & Infants Center

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Arginine; pembrolizumab; Bevacizumab; Paclitaxel; Dimethoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• Rebecca C Arend, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca C Arend, MD

CONTACT

(205) 934-4986; rarend@uabmc.edu

Rebecca A Arend

CONTACT

2059752257; al2eli@uab.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

US (1)