Clinical Trials /

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

NCT04498117

Description:

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.

Related Conditions:
  • Fallopian Tube Adenocarcinoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Undifferentiated Carcinoma
  • High Grade Fallopian Tube Serous Adenocarcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Ovarian Adenocarcinoma
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Seromucinous Carcinoma
  • Primary Peritoneal Clear Cell Carcinoma
  • Primary Peritoneal Endometrioid Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Primary Peritoneal Undifferentiated Carcinoma
  • Undifferentiated Ovarian Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery
  • Official Title: A Multicenter Phase 3, Double-Blind, Placebo-Controlled Study Comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin- Oregovomab) vs Chemotherapy (Paclitaxel-Carboplatin- Placebo) in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: QPT-ORE-005
  • SECONDARY ID: GOG 3035
  • NCT ID: NCT04498117

Conditions

  • Carcinoma, Ovarian Epithelial
  • Ovarian Neoplasms
  • Ovarian Cancer
  • Ovarian Serous Adenocarcinoma
  • Fallopian Tube Neoplasms
  • Fallopian Tube Adenocarcinoma
  • Fallopian Tube Serous Adenocarcinoma
  • Peritoneal Cancer
  • Peritoneal Carcinoma
  • Peritoneal Neoplasms

Interventions

DrugSynonymsArms
OregovomabMAb-B43.13Cohort 1- Surgery Active
PaclitaxelTaxolCohort 1 - Primary Surgery Control
CarboplatinParaplatinCohort 1 - Primary Surgery Control
PlaceboCohort 1 - Primary Surgery Control

Purpose

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.

Detailed Description

      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).
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1- Surgery ActiveExperimentalSix (6) 21-day cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).
  • Oregovomab
  • Paclitaxel
  • Carboplatin
Cohort 1 - Primary Surgery ControlPlacebo ComparatorSix (6) 21-day cycles of chemotherapy with placebo comparator given with chemotherapy at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).
  • Paclitaxel
  • Carboplatin
  • Placebo
Cohort 2 - NACT + Interval Surgery ActiveExperimentalIn Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).
  • Oregovomab
  • Paclitaxel
  • Carboplatin
Cohort 2 - NACT + Interval Surgery ControlPlacebo ComparatorIn Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with placebo comparator given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).
  • Paclitaxel
  • Carboplatin
  • Placebo

Eligibility Criteria

        Major Inclusion Criteria:

          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:

               1. Absolute neutrophil count (ANC) □ 1,500/µL

               2. Platelets □ 100,000/µL

               3. Hemoglobin □ 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before
                  first dose of study treatment).

          7. Adequate liver function:

               1. Bilirubin < 1.5 times upper limit normal (ULN)

               2. Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN

               3. Albumin >3.5 g/dL

          8. Adequate renal function:

             a. Creatinine □ 1.5 times ULN

          9. ECOG Performance Status of 0 or 1.

        Major Exclusion Criteria:

          1. BRCA1 or BRCA2 germline gene mutation test result with:

               1. Positive, ambiguous or inconclusive result available within 28 days prior to
                  starting study treatment, or

               2. Known BRCA1 and BRCA2 somatic mutations, and known positive germline, or

               3. Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor
                  front-line maintenance therapy.

          2. Subjects with mucinous adenocarcinoma and low- grade adenocarcinoma.

          3. Female subjects who are lactating and breastfeeding, or have a positive serum
             pregnancy test within 7 days prior to the first dose of study treatment (C1D1 for
             Cohort 1 or C4D1 for Cohort 2).

          4. Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus
             (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing
             spondylitis requiring active disease modifying treatment.

          5. Known allergy to murine proteins or hypersensitivity to any of the excipients of the
             oregovomab, paclitaxel, or carboplatin.

          6. Chronically treated with immunosuppressive drugs such as cyclosporine,
             adrenocorticotropic hormone (ACTH), etc. (see Appendix G).

          7. Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or
             equivalent, with the exception of inhalers or those on a pre-planned steroid taper.
             (Note: Premedication with corticosteroids per institutional standard of care is
             allowed.)

          8. Recognized acquired, hereditary, or congenital immunodeficiency disease, including
             cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.

          9. Anticipated treatment with any other anti-cancer medications, including bevacizumab,
             poly (ADP- ribose) polymerase (PARP) inhibitors, or any investigational agent(s)
             during the study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Investigator Assessed Progression Free Survival
Time Frame:Date of randomization until date of first documented disease progression or date of death from any cause, whichever comes first, at up to approximately 4 years.
Safety Issue:
Description:Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or death

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:Date of randomization up until date of death from any cause, up to approximately 8 years
Safety Issue:
Description:Date of randomization to the date of death Date of randomization to the date of death Date of randomization to the date of death

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:OncoQuest Pharmaceuticals Inc.

Last Updated

August 26, 2020