A clinical study to compare the efficacy and safety of five administrations of oregovomab versus placebo, infused in schedule dependent sequence with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of patients with newly diagnosed advanced ovarian cancer who are planned to receive neoadjuvant treatment followed by interval debulking surgery (IDS) and adjuvant treatment.
Phase 2, double-blind, placebo-controlled, multi-center study to compare the efficacy and safety of five administrations of oregovomab 2 mg IV versus placebo, infused in a schedule dependent sequence with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of patients with newly diagnosed advanced ovarian cancer who are planned to receive neoadjuvant treatment. Patients will receive oregovomab or placebo at Cycles 1 and 3 in combination with paclitaxel and carboplatin prior to IDS, followed by oregovomab or placebo at Cycles 4 and 6 in combination with paclitaxel and carboplatin, and oregovomab or placebo monotherapy at Cycle 6 plus 12 weeks. This study will screen approximately 96 patients to randomize approximately 88 patients. All eligible patients will be stratified by FIGO Stage (Stages IIIA, IIIB versus Stages IIIC, IV). The study includes screening period, treatment period, post-treatment follow up, safety follow and long term follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
88
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
175 mg/m\^2, every 3 weeks
AUC 5 or 6 IV Day 1 x 6 cycles (every 21 days)
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
Omega Hospitals
Visakhapatnam, Andhra Pradesh, India
King George Hospital
Visakhapatnam, Andhra Pradesh, India
Himalaya Cancer Hospital and Research Institute
Vadodara, Gujarat, India
Kailash Cancer Hospital and Research Centre
Vadodara, Gujarat, India
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, India
Amrita Institute of Medical Sciences
Kochi, Kerala, India
Regional Cancer Centre, Medical College
Trivandrum, Kerala, India
Sri Ram Cancer Hospital
Jaipur, Rajasthan, India
Saveetha Medical College and Hospitals
Chennai, Tamil Nadu, India
Sri Ramchandra Medical Centre
Chennai, Tamil Nadu, India
...and 4 more locations
Progression-free survival (PFS) Rate at 12 months
PFS, is assessed from date of randomization to the date of first documented progression as per RECIST v1.1 as determined by the investigator or death due to any cause.
Time frame: At 12 months
Overall Response Rate (ORR)
Overall response rate is defined according to RECIST v1.1 measured at end of first 3 cycles of study treatment and prior to debulking surgery treatment: * Complete response * Partial Response
Time frame: At 3 months
Disease Control Rate (DCR):
Disease control rate is defined according to RECIST v1.1 measured at end of first 3 cycles of treatment and prior to debulking surgery treatment: * Complete response * Partial Response * Stable Disease
Time frame: At 3 months
Response to Surgery
Upon completion of neo-adjuvant treatment and IDS, Response to surgery will be assessed on the size of residual disease - none (R0), \< 1 cm (R1), ≥ 1 cm (R2)
Time frame: At 4 months
Progression Free Survival
Progression free survival is defined as date of randomization to date of first documented progression as per RECIST v1.1 as determined by the investigator or death due to any cause and OS defined as date of randomization to date of death due to any cause.
Time frame: Approximately up to 4 years
Overall Survival
Overall survival is defined as date of randomization to date of death due to any cause.
Time frame: Approximately up to 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.