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

NOT YET RECRUITING

NCT07772882

PHASE1

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

2026-10-15

Healthy Volunteers

No

Conditions

Platinum Resistant Ovarian Cancer Fallopian Tube Cancers Peritoneal Carcinoma

Interventions

DRUG

(Arginaid®) Oral Arginine

Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.

DRUG

(R-Gene® 10) IV Arginine

Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.

DRUG

Pembrolizumab

Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.

DRUG

Bevacizumab

Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.

DRUG

Paclitaxel

Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.

DRUG

oral phosphamide

Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.

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 \<1%, patients can only enroll on treatment cohort B. 4. Patients must have high-grade serous or endometrioid histology 5. 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 6. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent 7. Patients must have adequate hematologic, liver and kidney functions prior to lead-in chemotherapy defined as: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109 /L (1,500/μL) 2. Platelet count ≥ 100 x 109 /L (100,000/μL) without platelet transfusion in the prior 10 days 3. Hemoglobin ≥ 9.0 g/dL 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN 6. Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN) 7. Serum albumin ≥ 2 g/dL. Exclusion Criteria: 1. History of allergic reactions contributed to compounds of similar chemical or biological composition to R-Gene 10 or Arginaid. 2. Patient unwilling/unable to receive daily arginine treatment (IV or oral) 3. Patients with a history of serologically confirmed HSV-1 or HSV-2 outbreaks 4. Receiving systemic corticosteroids or have severe comorbities where treatment with corticosteroids may be required. 5. Actively treated auto-immune disease. 6. Taking medications that interfere with the urea cycle such as valproate or xanthine oxidase inhibitors. 7. Current intercurrent illnesses including active infection, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmias. 8. Patients with history of Peptic Ulcer Disease 9. Contraindications to receive standard of care treatment backbone with either paclitaxel, bevacizumab, pembrolizumab, or cyclophosphamide.

Locations (1)

University of Alabama at Birmingham Womens & Infants Center

Birmingham, Alabama, United States

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