Phase 1b/2, Single Arm Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Bevacizumab, Paclitaxel Carboplatin as a Combinatorial Strategy in Subjects With BRCA-wild Type Platinum Sensitive Recurrent Ovarian Cancer

Who is this study for? Patients with Ovarian Cancer
What treatments are being studied? Oregovomab+Bevacizumab+Paclitaxel+Carboplatin
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Healthy Volunteers: f
View:

• Adult females (19 years old and older) with CA125-associated recurrent epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin.

• Have one of the eligible histologic epithelial cell types: serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.).

• Patients must have had a complete or partial response to front-line platinum-based therapy (at least three cycles) and a treatment -free interval without clinical evidence of progressive disease at least 6 months.

• No known deleterious or pathogenic germline or somatic BRreast CAncer gene (BRCA) mutation

• Must have had an elevated serum CA125 \> 2 times of UNL measured at the first diagnosis or screening within 28 days of start of study treatment.

• Must have measurable disease, including identification of marker lesions, by radiographic or physical criteria suitable for evaluation according to RECIST v1.1 for documentation of disease response or progression.

• Must have a ECOG Performance Status of 0, 1 or 2

• Must have adequate organ function defined as:

‣ neutrophil count ≥1000 μL

⁃ platelet count ≥100,000 μL

⁃ Hemoglobin \>9.0 g/dl

⁃ Serum creatinine \<1.5 times the upper normal limits (UNL) or creatinine clearance \> 45 mL/min/1.73 m2

⁃ bilirubin \<1.5 times the UNL

⁃ SGOT and SGPT \< 2 times the UL

• Must have voluntarily agreed to participate and have signed the informed consent, and are willing to complete all study procedures.

Locations
Other Locations
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
CHA Bundang Medical Center
RECRUITING
Seongnam-si
Asan Medical Hospital
RECRUITING
Seoul
Korea Anam Hospital
RECRUITING
Seoul
Seoul St. Mary's Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Dr Jung KH, MD
khjung@amc.seoul.kr
82-70-4459-4516
Backup
Dr Hong SH, MD
ssuki76@catholic.ac.kr
Time Frame
Start Date: 2021-03-17
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 54
Treatments
Experimental: oregovomab, bevacizumab, paclitaxel and carboplatin
Combination of anti-angiogenesis and Chemo-immunotherapy
Authors
Dr CHOI YJ
Related Therapeutic Areas
Sponsors
Leads: CanariaBio Inc.
Collaborators: Korean Cancer Study Group

This content was sourced from clinicaltrials.gov

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