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

NCT ID: NCT04938583

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

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.

Conditions

Ovarian Cancer by FIGO Stage; Ovarian Cancer Stage III; Ovarian Cancer Stage IV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

oregovomab, bevacizumab, paclitaxel and carboplatin

Combination of anti-angiogenesis and Chemo-immunotherapy

Group Type: EXPERIMENTAL

Oregovomab

Intervention Type: 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

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Interventions

Oregovomab

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

Intervention Type: BIOLOGICAL

Bevacizumab

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

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: DRUG

Carboplatin

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

Intervention Type: DRUG

Other Intervention Names

MAb-B43.13; Avastin; Taxol, Paxcel, Padexol; Neoplatin

Eligibility Criteria

Inclusion Criteria

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

2. 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.).

3. 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.

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

5. 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.

6. 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.

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

8. Must have adequate organ function defined as:

1. neutrophil count ≥1000 μL

2. platelet count ≥100,000 μL

3. Hemoglobin >9.0 g/dl

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

5. bilirubin <1.5 times the UNL

6. SGOT and SGPT < 2 times the UL

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

Exclusion Criteria

1. Patients who have received more than one line of chemotherapy (maintenance is not considered a second line)

2. Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring continuing immune suppressive therapy

3. Use of immunosuppressants within 28 days prior to the first administration of the current or clinical trial drug. However, intranasal, inhalation, and systemic administration of prednisone 10 mg/day or a physiological dose not exceeding the equivalent dose of corticosteroids are recognized as exceptions.

4. Known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or a known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure.

5. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections (testing during the study is not mandatory).

6. Recognized immunodeficiency condition including human immunodeficiency virus (HIV) infection, cellular immunodeficiencies, hypogamma globulinemia or dysgammaglobulinemia; subjects who have acquired, hereditary, or congenital immunodeficiency's, including HIV infection

7. Patients with previous solid organ transplantation

8. Evidence of clinically significant cardiovascular conditions including uncontrolled hypertension, myocardial infarction within 1 year, uncontrolled or unstable angina, congestive heart failure (New York Heart Association Class III or IV), arrhythmia (Grade 2 or higher), chronic obstructive pulmonary disease, clinical significant proteinuria (>1g/24hr urine)

9. Patients with other invasive malignancies, with the exception of non-melanomatous skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates with this protocol.

10. Have ever previously received oregovomab or bevacizumab

11. Patients who received major surgical procedure within 28days

12. Pregnant or breast-feeding

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Korean Cancer Study Group

OTHER

Sponsor Role: collaborator

CanariaBio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Jung KH, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Jung KH, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Hospital

Locations

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status: RECRUITING

CHA Bundang Medical Center

Seongnam-si, , South Korea

Site Status: RECRUITING

Korea Anam Hospital

Seoul, , South Korea

Site Status: RECRUITING

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Asan Medical Hospital

Seoul, , South Korea

Site Status: RECRUITING

Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Dr Jung KH, MD

Role: CONTACT

khjung@amc.seoul.kr

82-70-4459-4516

Dr Hong SH, MD

Role: CONTACT

ssuki76@catholic.ac.kr

Facility Contacts

Dr Lee IH, MD

Role: primary

Dr Moon YW, MD

Role: primary

Dr Choi YJ, MD

Role: primary

Dr Kim MH, MD

Role: primary

Dr Jung KH, MD

Role: primary

khjung@amc.seoul.kr

Dr Hong SH, MD

Role: primary

ssuki76@catholic.ac.kr

Other Identifiers

KCSG GY20-10

Identifier Type: -

Identifier Source: org_study_id