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Arginine + Chemoimmunotherapy for Ovarian Cancer

RC
RA
Overseen ByRebecca A Arend
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: Rebecca Arend
Must be taking: Arginine
Must not be taking: Corticosteroids, Valproate, Xanthine oxidase
Disqualifiers: HSV, Auto-immune, Heart failure, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

RC

Rebecca C Arend, MD

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults with ovarian, fallopian tube, or peritoneal cancer that has come back or not responded to platinum-based chemotherapy. Participants should be in generally stable health and able to receive more treatment.

Inclusion Criteria

I am eligible for one of the study's main treatment groups.
My PD-L1 status is unknown or less than 1%, so I can only join cohort B.
I am at least 18 years old.
See 7 more

Exclusion Criteria

I am not able or willing to take daily arginine treatment.
I am taking medications that affect the urea cycle, like valproate or xanthine oxidase inhibitors.
History of allergic reactions to compounds similar to R-Gene 10 or Arginaid
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IV and PO arginine supplementation with standard of care chemoimmunotherapy regimens

Up to 2 years
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
3-month and 6-month evaluations

What Are the Treatments Tested in This Trial?

Interventions

  • Arginaid® Oral Arginine
  • Bevacizumab
  • Oral Cyclophosphamide
  • Paclitaxel
  • Pembrolizumab
  • R-Gene® 10 IV Arginine

Trial Overview

The study tests if adding arginine (given by IV or orally) to standard chemoimmunotherapy—using drugs like pembrolizumab, bevacizumab, paclitaxel, and oral phosphamide—is safe and effective for these cancers.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: CPS>1, physician's choice for Cohort A or Cohort BExperimental Treatment6 Interventions
Group II: CPS<1, must be assigned to Cohort BExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rebecca Arend

Lead Sponsor

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