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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Oregovomab — BIOLOGICAL
  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
• Paclitaxel — DRUG
  175 mg/m\^2, every 3 weeks
• Carboplatin — DRUG
  AUC 6 IV Day 1 x 6 cycles (every 21 days)
• Placebo — BIOLOGICAL
  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
• Carboplatin — DRUG
  AUC 5-6 IV Day 1 x 6 cycles (every 21 days)

Study Details

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.

Key Dates

First listed

Aug 4, 2020

Start date

Aug 25, 2020

Status verified

Mar 2026

Primary completion

Dec 26, 2026

Completion

Aug 26, 2028

Study Design

Enrollment

615 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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).
• 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).
• 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).
• 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).

Primary Outcome 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 6 years. ]

Locations (81)

Find similar trials in Phoenix, AZ

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