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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Rebecca Arend
Study ID
NCT07772882
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Cohort A1 — DRUG
    Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + 4.5g daily oral arginine
  • Cohort A2 — DRUG
    Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine
  • Cohort A3 — DRUG
    Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine
  • A3 Expansion — DRUG
    Continue - Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine
  • Cohort B1 — DRUG
    q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 4.5g daily oral arginine
  • Cohort B2 — DRUG
    q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine
  • Cohort B3 — DRUG
    q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine
  • B3 Expansion — DRUG
    Continue - q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Proportion of patients with serious adverse events [ Time Frame: Baseline through year 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Womens & Infants CenterBirminghamAlabama35233
Rebecca C Arend, MD
[email protected]

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By research site
University of Alabama at Birmingham Womens & Infants Center· Birmingham, AL

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