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

Korábbi kezelés

• Receiving systemic corticosteroids or have severe comorbities where treatment with corticosteroids may be required.
• Taking medications that interfere with the urea cycle such as valproate or xanthine oxidase inhibitors.
• Contraindications to receive standard of care treatment backbone with either paclitaxel, bevacizumab, pembrolizumab, or cyclophosphamide.

Más betegség

• History of allergic reactions contributed to compounds of similar chemical or biological composition to R-Gene 10 or Arginaid.
• Patients with a history of serologically confirmed HSV-1 or HSV-2 outbreaks
• Actively treated auto-immune disease.
• Current intercurrent illnesses including active infection, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmias.
• Patients with history of Peptic Ulcer Disease

Egyéb

• Patient unwilling/unable to receive daily arginine treatment (IV or oral)

• 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)
  • Serum albumin ≥ 2 g/dL.