Overview

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

Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
OncoQuest Pharmaceuticals Inc.
Collaborator:
Korean Cancer Study Group
Treatments:
Bevacizumab
Carboplatin
Oregovomab
Paclitaxel
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, 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