Platinum Resistant Ovarian CancerPhase 1NCT07772882
Study of Supplemental Arginine With Chemotherapy and Immunotherapy in Platinum Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer
A Phase 1 study testing (Arginaid®) Oral Arginine, (R-Gene® 10) IV Arginine and Pembrolizumab in people with Platinum Resistant Ovarian Cancer and Fallopian Tube Cancers, run by Rebecca Arend at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Platinum Resistant Ovarian Cancer, Fallopian Tube Cancers, Peritoneal Carcinoma
- What is being tested?
- (Arginaid®) Oral Arginine, (R-Gene® 10) IV Arginine and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jan 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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)
- Serum albumin ≥ 2 g/dL.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham Womens & Infants Center
Birmingham, Alabama, 35233
Rebecca C Arend, MD, rarend@uabmc.edu
About this study
Official title: Phase I Study of Supplemental Arginine With Chemotherapy and Immunotherapy in Platinum Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer
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.
Read the detailed description
This is a Phase I, investigator-initiated and open-label study. Patients will be evaluated and treated at University of Alabama Birmingham Hospital. Patients will receive both oral and IV arginine with the physician choice of paclitaxel, pembrolizumab, +/- bevacizumab or pembrolizumab, bevacizumab, and oral cyclophosphamide, where doses and schedule are consistent with standard of care. Patients who are excluded from the trial due to progression will be scheduled for three- and six-months follow-up evaluations after the last dose. The goal for enrollment will be 6-24 patients with a 3-patient safety dose escalation lead-in using a 3+3 enrollment model for each regimen.
Patients meeting eligibility criteria will be approached and both verbal and written consent will be obtained prior to treatment. Patients on trial will receive the IV R-Gene 10 (30g) IV arginine, every 3 weeks (q3w) plus PO Arginaid 4.5g PO daily with one of two systemic standard of care treatment regimens: Standard of care treatment #1 is 50mg of daily oral cyclophosphamide, intravenous pembrolizumab 200 mg q3w, and bevacizumab, 15 mg/kg, q3w; standard of care treatment #2 is weekly paclitaxel 80mg/m2 and 200mg of IV pembrolizumab q3wks +/- bevacizumab, 15 mg/kg, q3w in patients with CPS >1.
(CPS) Combined Positive Score (PD-L1)
- Being tested
- (Arginaid®) Oral Arginine, (R-Gene® 10) IV Arginine, Pembrolizumab, Bevacizumab, Paclitaxel
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Arginaid®) Oral ArginineDrug
Also called 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.
(R-Gene® 10) IV ArginineDrug
Also called 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.
PembrolizumabDrug
Also called Keytruda
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.
BevacizumabDrug
Also called AVASTIN®
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.
PaclitaxelDrug
Also called Taxol
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.
oral phosphamideDrug
Also called cyclophosphamide
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 (Arginaid®) Cohort A2_Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine (R-Gene® 10) Cohort A3_Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine (Arginaid®) A3 Expansion_Continue previous regimen
OR
Cohort B:
Cohort B1_q3w IV bevacizumab, q3w IV pembrolizumab, daily oral phosphamide, 4.5g daily oral arginine (Arginaid®) Cohort B2_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine (R-Gene® 10) Cohort B3_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine (R-Gene® 10) + 4.5g PO arginine (Arginaid®) B3 Expansion_ Continue previous regimen Receives: Drug: (Arginaid®) Oral Arginine; Drug: (R-Gene® 10) IV Arginine; Drug: Pembrolizumab; Drug: Bevacizumab; Drug: Paclitaxel; Drug: oral phosphamide |
| 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 (Arginaid®) Cohort B2_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine (R-Gene® 10) Cohort B3_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine (R-Gene® 10) + 4.5g PO arginine (Arginaid®) B3 Expansion_ Continue previous regimen Receives: Drug: (Arginaid®) Oral Arginine; Drug: (R-Gene® 10) IV Arginine; Drug: Pembrolizumab; Drug: Bevacizumab; Drug: oral phosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with serious adverse events
This measures the proportion of patients experiencing serious adverse events
Measured: Baseline through year 2
Secondary outcomes (5)
Overall Response Rate
Tumor burden will be evaluated in all participants by the investigator at screening and during/after the intervention period per RECIST 1.1 guidelines. Based on changes in tumor burden, participants will be classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). Participants who are classified as CR or PR will be defined as responders. The overall response rate (ORR) is the proportion of responders out of the evaluable participants. ORR = (PR + CR)/(PR + CR+ SD+ PD)
Measured: Baseline through year 2
Duration of Response
Duration of response (DOR) is a time-to-event endpoint measured only in participants who respond to treatment. DOR is the time between response to treatment and disease progression or death. Patients who are lost to follow-up before disease progression or death are censored at time of last contact.
Measured: Baseline through year 2
Disease control rate
Tumor burden will be evaluated in all participants by the investigator at screening and during/after the intervention period per RECIST 1.1 guidelines. Based on changes in tumor burden, participants will be classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). Participants who are classified as CR, PR or SD will be defined as having disease control. The disease control rate (DCR) is the proportion of participants with disease control out of the evaluable participants. DCR = (PR + CR + SD)/(PR + CR+ SD+ PD)
Measured: Baseline through year 2
Progression Free Survival
Progression free survival (PFS) is a time-to-event endpoint. PFS is the time between start of treatment and the earlier of disease progression or death. Patients who are lost to follow-up before disease progression or death are censored at time of last contact.
Measured: Baseline through year 2
Overall Survival
Overall survival (OS) is a time-to-event endpoint. OS is the time between start of treatment and death. Patients who are lost to follow-up before death are censored at time of last contact.
Measured: Baseline through year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum Resistant Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rebecca Arend
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rebecca Arend, University of Alabama at Birmingham
- Investigators
- Rebecca C Arend, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772882
- Sponsor's protocol ID
- IRB-300016887 (UAB 2667)
- Other IDs
- O'Neal Cancer Center
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No