Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery (FLORA-5)
- Conditions
- Malignant neoplasm of unspecifiedovary,
- Registration Number
- CTRI/2022/05/042562
- Lead Sponsor
- OncoQuest Pharmaceuticals Inc
- Brief Summary
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).
Arms and Interventions
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).
Intervention/Treatment
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 602
- Major Inclusion Criteria: 1. Adults 18 years old or older. 2. Subjects with newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease. 3. Eligible 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), as defined below: a. For subjects who undergo primary debulking surgery (Cohort 1.
- Primary Surgery): i. Cycle 1 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after primary debulking surgery, and ii. The primary debulking surgery is optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor). b. For subjects who will undergo interval debulking surgery (Cohort 2 – NACT/Interval Surgery): i. Subject must have received neoadjuvant treatment with 3 cycles of paclitaxel 175 mg/m2 IV over 3 hours every approximately 3 weeks (21 Days), followed by carboplatin area under the curve (AUC) 5-6 administered intravenously (IV) approximately every 3 weeks (21 Days), and ii. Cycle 4 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after interval debulking surgery, and iii. The interval debulking surgery is optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor). 5. Suitable venous access for the study-required procedures. 6. Cohort 1 – Primary Surgery: Preoperative serum CA-125 levels ≥ 50 U/mL, or Cohort 2 – NACT + Interval Surgery: serum CA-125 levels ≥ 50 U/mL prior to first pre-operative chemotherapy (chemotherapy cycle #1). 7. Adequate bone marrow function: a. Absolute neutrophil count (ANC) ≥ 1,500/μL. b. Platelets ≥ 100,000/μL. 8. Hemoglobin ≥ 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment). 9. Adequate liver function: a. Bilirubin < 1.5 times upper limit normal (ULN). b. Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN. c. Albumin >3.5 g/dL. 10. Adequate renal function: a. Creatinine ≤ 1.5 times ULN. 11. ECOG Performance Status of 0 or 1. 12. For women of childbearing potential, must be willing to avoid pregnancy by using a highly effective method of contraception from the first dose of study treatment to 60 days after last dose of study treatment. Adequate contraception is defined in Section 8.2.5). 13. Sign informed consent and authorization permitting release of personal health information. 14. Willingness and ability to complete patient quality of life questionnaires.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome Measures : [ 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. ] 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 [ 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. ]
- Secondary Outcome Measures
Name Time Method Secondary Outcome Measures : Overall Survival [ Time Frame: Date of randomization up until date of death from any cause, up to approximately 8 years ]
Trial Locations
- Locations (16)
All India lnstitute of Medical Sciences
🇮🇳West, DELHI, India
Chittaranjan National Cancer Institute
🇮🇳Kolkata, WEST BENGAL, India
Daycare Angels under Advani Olickal HealthCare (AOH) Sushrut Hospital And Research Center
🇮🇳Mumbai, MAHARASHTRA, India
Deenanath Mangeshkar Hospital
🇮🇳Pune, MAHARASHTRA, India
Fortis Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Fortis Hospital CG Road
🇮🇳Bangalore, KARNATAKA, India
Fortis Memorial Research Institute
🇮🇳Gurgaon, HARYANA, India
Manipal Hospital
🇮🇳Bangalore, KARNATAKA, India
Max Institute of Cancer Care
🇮🇳Delhi, DELHI, India
Max Super Speciality Hospital
🇮🇳East, DELHI, India
Scroll for more (6 remaining)All India lnstitute of Medical Sciences🇮🇳West, DELHI, IndiaDr Sachin KhuranaPrincipal investigator9769030180drsachintrials@gmail.com