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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04938583
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : June 24, 2021
Korean Cancer Study Group
Information provided by (Responsible Party):
Jung KH, MD, Korean Cancer Study Group

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer by FIGO Stage Ovarian Cancer Stage III Ovarian Cancer Stage IV Biological: Oregovomab Drug: Bevacizumab Drug: Paclitaxel Drug: Carboplatin Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 17, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
Experimental: oregovomab, bevacizumab, paclitaxel and carboplatin
Combination of anti-angiogenesis and Chemo-immunotherapy
Biological: Oregovomab

Oregovomab will be administered on day1 cycle 1, 3, 5, and 9 until DLT or disease progression. A minimum of 3 patients will be enrolled into each cohort.

2 mg, 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

Other Name: MAb-B43.13

Drug: Bevacizumab
15mg/Kg Day 1 (every 21 days) until progression
Other Name: Avastin

Drug: Paclitaxel
175 mg/m^2, Day 1 x 6 cycles (every 21 days)
Other Name: Taxol, Paxcel, Padexol

Drug: Carboplatin
AUC 5 IV Day 1 x 6 cycles (every 21 days)
Other Name: Neoplatin

Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 1cycle (21days) ]
    Assessment of Dose Limiting toxicity (DLT) based on incidences and severity of adverse events will be measured according to CTCAE v5.0

  2. Efficacy based on overall response rate (ORR) [ Time Frame: Every 6 weeks (each cycle is 21 days) ]
    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)

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Date of randomization up until date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to approximately 12 months ]
    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

  2. Overall Survival (OS) [ Time Frame: Date of randomization up until date of death from any cause, up to approximately 2 years ]
    OS, defined as date of first study treatment to date of death due to any cause

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

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, 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04938583

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Contact: Dr Jung KH, MD 82-70-4459-4516
Contact: Dr Hong SH, MD

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Korea, Republic of
Korea Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Dr CHOI YJ, MD         
Principal Investigator: Dr CHOI YJ, MD         
Seoul Asan Hospital Recruiting
Seoul, Korea, Republic of, 05505
Contact: Dr Jung KH, MD         
Principal Investigator: Dr Jung KH, MD         
Seoul St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of, 06591
Contact: Dr Hong SH, MD         
Principal Investigator: Dr Hong SH, MD         
Sponsors and Collaborators
OncoQuest Pharmaceuticals Inc.
Korean Cancer Study Group
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Principal Investigator: Dr Jung KH, MD Seoul Asan Hospital
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Responsible Party: Jung KH, MD, Professor, Korean Cancer Study Group Identifier: NCT04938583    
Other Study ID Numbers: KCSG GY20-10
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jung KH, MD, Korean Cancer Study Group:
CA 125
platinum-sensitive recurrent ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances