Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer

Sponsor
CanariaBio Inc.
Study ID
NCT04938583
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Ovarian Cancer Stage III
  • Ovarian Cancer Stage IV
  • Ovarian Cancer by FIGO Stage

Eligibility Criteria

Sex
FEMALE
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oregovomab — BIOLOGICAL
    Oregovomab will be administered on day1 cycle 1, 3, 5, and 9. A minimum of 3 patients will be enrolled into each cohort (2 mg or 1 mg). 2 mg (starting dose), 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
  • Bevacizumab — DRUG
    15mg/Kg Day 1 (every 21 days) until progression
  • Paclitaxel — DRUG
    175 mg/m\^2, Day 1 x 6 cycles (every 21 days)
  • Carboplatin — DRUG
    AUC 5 IV Day 1 x 6 cycles (every 21 days)

Study Details

This is a single arm phase 1b/2 evaluation of the combination of oregovomab, and bevacizumab, paclitaxel carboplatin in adult subjects with CA125-associated, advanced recurrent epithelial ovarian, fallopian tube or peritoneal carcinoma (FIGO Stage III/IV) with BRCA-wild type, previously treated with 1 prior lines of therapy, and with platinum free intervals of \>6 months since last platinum-based treatment.

Key Dates

First listed
Jun 24, 2021
Start date
Mar 17, 2021
Status verified
Apr 2026
Primary completion
Oct 30, 2025
Completion
Aug 31, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: oregovomab, bevacizumab, paclitaxel and carboplatin
    Combination of anti-angiogenesis and Chemo-immunotherapy

Primary Outcome Measure

Safety and Tolerability [ Time Frame: 1cycle (21days) ]

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