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| Name | Class |
|---|---|
| Korean Cancer Study Group | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oregovomab, bevacizumab, paclitaxel and carboplatin | Experimental | Combination of anti-angiogenesis and Chemo-immunotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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 |
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Inclusion Criteria:
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:
Must have voluntarily agreed to participate and have signed the informed consent, and are willing to complete all study procedures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Jung KH, MD | Asan Medical Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea Anam Hospital | Seoul | Seoul | 02841 | South Korea | ||
| Asan Medical Hospital |
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|
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| Bevacizumab | Drug | 15mg/Kg Day 1 (every 21 days) until progression |
|
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| Paclitaxel | Drug | 175 mg/m^2, Day 1 x 6 cycles (every 21 days) |
|
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| Carboplatin | Drug | AUC 5 IV Day 1 x 6 cycles (every 21 days) |
|
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| Overall Survival (OS) |
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 |
| Seoul |
| Seoul |
| 05505 |
| South Korea |
| Seoul St. Mary's Hospital | Seoul | Seoul | 06591 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| CHA Bundang Medical Center | Seongnam-si | 13496 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C107428 | oregovomab |
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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