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Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery

Status
Active
Cancer Type
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Female
Study Type
Treatment
NCT ID
NCT04498117
Protocol IDs
QPT-ORE-005 (primary)
NCI-2020-08028
FLORA5
FLORA-5
GOG 3035
GOG-3035
Study Sponsor
CanariaBio Inc.

Summary

Study to compare the safety and efficacy of oregovomab versus placebo, administered in
combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and
carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who
have undergone optimal debulking.

Objectives

Phase 3 double-blind, placebo-controlled, multi-center study to compare the safety and
efficacy of four administrations of oregovomab 2 mg IV versus placebo, administered in
combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and
carboplatin), for the treatment of subjects with newly diagnosed ovarian cancer who have
undergone optimal debulking surgery and are either pending initiation of chemotherapy (Cohort
1 - Primary Surgery) or resumption of another three cycles of chemotherapy, having already
completed three cycles of neoadjuvant chemotherapy (Cohort 2 - NACT + Interval Surgery).

For Cohort 1 - Primary Surgery, 372 subjects randomized in a 1:1 ratio (i.e., chemotherapy
with oregovomab or chemotherapy with placebo). For Cohort 2 - NACT + Interval Surgery, 230
subjects will be randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or
chemotherapy and placebo).

Eligibility

  1. Adults 18 years old or older.
  2. Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease.
  3. Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
  4. Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator). Debulking surgery must be optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor).
  5. Preoperative serum CA- 125 levels = 50 U/mL.
  6. Adequate bone marrow function:
  7. Absolute neutrophil count (ANC) greater than or equal to 1,500/µL
  8. Platelets greater than or equal to100,000/µL
  9. Hemoglobin greater than or equal to 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).
  10. Adequate liver function:
  11. Bilirubin < 1.5 times upper limit normal (ULN)
  12. Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
  13. Albumin >3.5 g/dL
  14. Adequate renal function: a. Creatinine less than or equal to1.5 times ULN
  15. ECOG Performance Status of 0 or 1.

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