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Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery (FLORA-5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04498117
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : September 15, 2020
Sponsor:
Collaborators:
The GOG Foundation, Inc.
IQVIA RDS Inc.
Information provided by (Responsible Party):
OncoQuest Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
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 Biological: Oregovomab Drug: Paclitaxel Drug: Carboplatin Biological: Placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 602 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 25, 2020
Estimated Primary Completion Date : June 26, 2024
Estimated Study Completion Date : August 26, 2027


Arm Intervention/treatment
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).
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

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).
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

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).
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

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).
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Other Outcome Measures:
  1. 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).

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498117


Contacts
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Contact: VP Product Development 780-448-1400 ext 221 ClinicalTrialDisclosures@oncoquestinc.com
Contact: Clinical Operations ClinicalTrialDisclosures@oncoquestinc.com

Locations
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United States, Georgia
Lewis Cancer & Research Pavilion at St. Joseph's Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: Sarah Gill, MD       drgills@sjchs.org   
Principal Investigator: Sarah Gill, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: John Schorge, MD         
Principal Investigator: John Schorge, MD         
Sub-Investigator: Young Kim, MD         
Sponsors and Collaborators
OncoQuest Pharmaceuticals Inc.
The GOG Foundation, Inc.
IQVIA RDS Inc.
Investigators
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Study Director: Eliel Bayever, MRCP OncoQuest Pharmaceuticals Inc.
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Responsible Party: OncoQuest Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04498117    
Other Study ID Numbers: QPT-ORE-005
GOG 3035 ( Other Identifier: Gynecologic Oncology Group )
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Adenocarcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Cystadenocarcinoma, Serous
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Paclitaxel
Carboplatin
Oregovomab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents