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

October 14, 2023 updated by: Jung KH, MD, CanariaBio Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Contact:
          • Dr Lee IH, MD
        • Principal Investigator:
          • Dr Lee IH, MD
      • Seongnam-si, Korea, Republic of, 13496
        • Recruiting
        • CHA Bundang Medical Center
        • Contact:
          • Dr Moon YW, MD
        • Principal Investigator:
          • Dr Moon YW, MD
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Seoul St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Dr Hong SH, MD
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital
        • Contact:
          • Dr Kim MH, MD
        • Principal Investigator:
          • Dr Kim MH, MD
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea Anam Hospital
        • Contact:
          • Dr Choi YJ, MD
        • Principal Investigator:
          • Dr Choi YJ, MD
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Hospital
        • Contact:
        • Principal Investigator:
          • Dr Jung KH, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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. 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

Other Names:
  • MAb-B43.13
Drug: Bevacizumab
15mg/Kg Day 1 (every 21 days) until progression
Other Names:
  • Avastin
Drug: Paclitaxel
175 mg/m^2, Day 1 x 6 cycles (every 21 days)
Other Names:
  • Taxol, Paxcel, Padexol
Drug: Carboplatin
AUC 5 IV Day 1 x 6 cycles (every 21 days)
Other Names:
  • Neoplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1cycle (21days)
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)
Every 6 weeks (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Date of randomization up until date of first documented disease progression or date of death from any cause, whichever comes first
Overall Survival (OS)
Time Frame: Date of randomization up until date of death from any cause
OS, defined as date of first study treatment to date of death due to any cause
Date of randomization up until date of death from any cause

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CanariaBio Inc.

Collaborators

Korean Cancer Study Group

Investigators

  • Principal Investigator: Dr Jung KH, MD, Asan Medical Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCSG GY20-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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