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

NCT04938583 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: KCSG GY20-10
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

Oregovomab; CA 125; platinum-sensitive recurrent ovarian cancer; bevacizumab; paclitaxel; carboplatin

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability

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

  1cycle (21days)

• Efficacy based on overall response rate (ORR)

  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)

  Every 6 weeks (each cycle is 21 days)

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  Date of randomization up until date of first documented disease progression or date of death from any cause, whichever comes first

• Overall Survival (OS)

  Date of randomization up until date of death from any cause

Study Arms (1)

oregovomab, bevacizumab, paclitaxel and carboplatin

EXPERIMENTAL

Combination of anti-angiogenesis and Chemo-immunotherapy

Biological: Oregovomab; Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

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

Also known as: MAb-B43.13

oregovomab, bevacizumab, paclitaxel and carboplatin

Bevacizumab DRUG

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

Also known as: Avastin

oregovomab, bevacizumab, paclitaxel and carboplatin

Paclitaxel DRUG

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

Also known as: Taxol, Paxcel, Padexol

oregovomab, bevacizumab, paclitaxel and carboplatin

Carboplatin DRUG

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

Also known as: Neoplatin

oregovomab, bevacizumab, paclitaxel and carboplatin

Eligibility Criteria

• Age: 19 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have received more than one line of chemotherapy (maintenance is not considered a second line)
• Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring continuing immune suppressive therapy
• 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.
• 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.
• Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections (testing during the study is not mandatory).
• 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
• Patients with previous solid organ transplantation
• 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)
• 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.
• Have ever previously received oregovomab or bevacizumab
• Patients who received major surgical procedure within 28days
• Pregnant or breast-feeding

Sponsors & Collaborators

• CanariaBio Inc.: lead
• Korean Cancer Study Group: collaborator

Study Sites (6)

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

RECRUITING

CHA Bundang Medical Center

Seongnam-si, 13496, South Korea

RECRUITING

Korea Anam Hospital

Seoul, 02841, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Asan Medical Hospital

Seoul, 05505, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

oregovomab; Bevacizumab; Paclitaxel; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Dr Jung KH, MD

  Asan Medical Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Jung KH, MD

CONTACT

82-70-4459-4516; khjung@amc.seoul.kr

Dr Hong SH, MD

CONTACT

ssuki76@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 24, 2021
• Study Start: March 17, 2021
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2025
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)