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Trial record 1 of 1 for:    NCT04498117 | Recruiting, Not yet recruiting Studies
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Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery (FLORA-5)

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ClinicalTrials.gov Identifier: NCT04498117
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : January 26, 2022
Sponsor:
Collaborators:
Gynecologic Oncology Group
Iqvia Pty Ltd
Information provided by (Responsible Party):
OncoQuest Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE July 28, 2020
First Posted Date  ICMJE August 4, 2020
Last Update Posted Date January 26, 2022
Actual Study Start Date  ICMJE August 25, 2020
Estimated Primary Completion Date June 26, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2020)
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. ]
Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or death
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
Investigator Assessed Progression Free Survival [ Time Frame: Date of randomization up until date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to approximately 4 years. ]
Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or death
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2020)
Overall Survival [ Time Frame: Date of randomization up until date of death from any cause, up to approximately 8 years ]
Date of randomization to the date of death Date of randomization to the date of death Date of randomization to the date of death
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
Overall Survival [ Time Frame: Date of randomization up until date of death from any cause, whichever comes first, assessed up to approximately 8 years ]
Date of randomization to the date of death Date of randomization to the date of death Date of randomization to the date of death
Current Other Pre-specified Outcome Measures
 (submitted: August 4, 2020)
  • Functional Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O TOI) [ Time Frame: • Change from baseline in the global health status/QOL scale score of the FACT-O TOI, up to 4 years. ]
    Physical component of quality of life (QOL) measured by a modified Functional Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O-TOI).
  • NFOSI-18 [ Time Frame: Change from baseline in the NFOSI-18, assessed up to 4 years. ]
    Physical component of quality of life (QOL) will be measured using the FACT/NCCN Ovarian Symptom Index (FOSI).
Original Other Pre-specified Outcome Measures
 (submitted: July 30, 2020)
  • Functional Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O TOI) [ Time Frame: • Change from baseline in the global health status/QOL scale score of the Functional Assessment of Cancer Therapy-Ovary (FACT-O TOI) in each treatment group, assessed up to 4 years. ]
    Physical component of quality of life (QOL) will be measured using a modified Functional Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O-TOI).
  • NFOSI-18 [ Time Frame: Change from baseline in the NFOSI-18 in each treatment group, assessed up to 4 years. ]
    Physical component of quality of life (QOL) will be measured using the FACT/NCCN Ovarian Symptom Index (FOSI).
 
Descriptive Information
Brief Title  ICMJE Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery
Official Title  ICMJE 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
Brief 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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Biological: Oregovomab
    2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
    Other Name: MAb-B43.13
  • Drug: Paclitaxel
    175 mg/m^2, every 3 weeks
    Other Name: Taxol
  • Drug: Carboplatin
    AUC 6 IV Day 1 x 6 cycles (every 21 days)
    Other Name: Paraplatin
  • Biological: Placebo
    2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
Study Arms  ICMJE
  • Experimental: Cohort 1- Surgery Active
    Six (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).
    Interventions:
    • Biological: Oregovomab
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Placebo Comparator: Cohort 1 - Primary Surgery Control
    Six (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).
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Biological: Placebo
  • Experimental: Cohort 2 - NACT + Interval Surgery Active
    In 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).
    Interventions:
    • Biological: Oregovomab
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Placebo Comparator: Cohort 2 - NACT + Interval Surgery Control
    In 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).
    Interventions:
    • Drug: Paclitaxel
    • Drug: Carboplatin
    • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2020)
602
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 26, 2027
Estimated Primary Completion Date June 26, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) greater than or equal to 1,500/µL
    2. Platelets greater than or equal to100,000/µL
    3. 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).
  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 less than or equal to1.5 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Operations 1-780-448-1400 ClinicalTrialDisclosures@oncoquestinc.com
Listed Location Countries  ICMJE Argentina,   Belgium,   Canada,   Chile,   Czechia,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04498117
Other Study ID Numbers  ICMJE QPT-ORE-005
GOG-3035 ( Other Identifier: Gynecologic Oncology Group )
FLORA-5 ( Other Identifier: OncoQuest Pharmaceuticals Inc. )
FLORA5 ( Other Identifier: OncoQuest Pharmaceuticals Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party OncoQuest Pharmaceuticals Inc.
Study Sponsor  ICMJE OncoQuest Pharmaceuticals Inc.
Collaborators  ICMJE
  • Gynecologic Oncology Group
  • Iqvia Pty Ltd
Investigators  ICMJE
Study Director: Sunil Gupta, MD, FRCPC OncoQuest Pharmaceuticals Inc.
PRS Account OncoQuest Pharmaceuticals Inc.
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP