Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Carboplatin

Cisplatin

Immunomodulating Agents

Oregovomab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Combination of anti-angiogenesis and Chemo-immunotherapy

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

15mg/Kg Day 1 (every 21 days) until progression

175 mg/m\^2, Day 1 x 6 cycles (every 21 days)

AUC 5 IV Day 1 x 6 cycles (every 21 days)

Dr Jung KH, MD

Dr Hong SH, MD

Dr Lee IH, MD

Dr Moon YW, MD

Dr Choi YJ, MD

Dr Kim MH, MD

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.

This study is an open-label, single arm, phase 1b/II, multicenter study.

In phase 1b part, the recommended phase 2 dose of oregovomab combined with bevacizumab, paclitaxel and carboplatin will be examined. Approximately 3 to 12 subjects("3+3" dose finding design) will be enrolled in phase 1b trial with starting dose of 2mg oregovmab.

In Phase II trial, response rate of combination with oregovomab and bevacizumab, paclitaxel will be examined. Based on Simon's two stage model, 8 patients will be enrolled in first stage, after review of efficacy (response rate) of study treatment, 30 additional subjects for second stage of phase 2 will be enrolled. Considering 10% of screening failure rate, overall 42 patients will be enrolled in phase 2 trial.

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

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

Assessment of Dose Limiting toxicity (DLT) based on incidences and severity of adverse events will be measured according to CTCAE v5.0

Overall response rate measured as the Percentage of Participants with a Complete Response (CR) or Partial Response (PR), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECISTv1.1)

PFS, defined as date of first study treatment to the date of event defined as the first documented progression as per RECIST v1.1 or death due to any cause

OS, defined as date of first study treatment to date of death due to any cause

Korean Cancer Study Group

CanariaBio Inc.

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer	NCT04938583	Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ...	Oregovomab Bevacizumab Paclitaxel Carboplatin	19 Years -	CanariaBio Inc.
Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer	NCT04938583	Ovarian Cancer ... Ovarian Cancer ... Ovarian Cancer ...	Oregovomab Bevacizumab Paclitaxel Carboplatin	19 Years -	CanariaBio Inc.

Spots Global Cancer Trial Database for ovarian cancer by figo stage