Clinical Trials List
Protocol NumberQPT-ORE-005
NCT Number(ClinicalTrials.gov Identfier)NCT04498117
2020-08-31 - 2026-03-31
Phase III
Recruiting6
A Multicenter Phase 3, Double-Blind, Placebo-Controlled Study Comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin- Oregovomab) vs Chemotherapy (Paclitaxel-Carboplatin- Placebo) in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
OncoQuest Pharmaceuticals Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Huann-Cheng Horng Division of Obstetrics & Gynecology
- Yi-Jen Chen Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Keng-Fu Hsu Division of Obstetrics & Gynecology
- 鄭雅敏 Division of Obstetrics & Gynecology
- Cheng-Yang Chou Division of Obstetrics & Gynecology
- 吳佩瑩 Division of Obstetrics & Gynecology
- Meng-Ru Shen Division of Obstetrics & Gynecology
- 吳珮瑩 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- Wen-Fang Cheng Division of Obstetrics & Gynecology
- YING-CHENG CHIANG Division of Obstetrics & Gynecology
- 施怡倫 Division of Radiology
- 陳祈安 Division of Obstetrics & Gynecology
- 陳宇立 Division of Obstetrics & Gynecology
- 郭冠廷 Division of Others
- 童寶玲 Division of Obstetrics & Gynecology
- 戴依柔 Division of Obstetrics & Gynecology
- CHI-HAU CHEN CHI-HAU CHEN Division of Obstetrics & Gynecology
- - - Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳鵬宇 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wei-Chun Chang 無
- 黃千竹 無
- Wu-Chou Lin 無
- 宋鈺雯 無
- Yin-Yi Chang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma
Objectives
Study to compare the safety and efficacy of oregovomab versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who have undergone optimal debulking.
Phase 3 double-blind, placebo-controlled, multi-center study to compare the safety and efficacy of four administrations of oregovomab 2 mg IV versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed ovarian cancer who have undergone optimal debulking surgery and are either pending initiation of chemotherapy (Cohort 1 - Primary Surgery) or resumption of another three cycles of chemotherapy, having already completed three cycles of neoadjuvant chemotherapy (Cohort 2 - NACT + Interval Surgery).
For Cohort 1 - Primary Surgery, 372 subjects randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or chemotherapy with placebo). For Cohort 2 - NACT + Interval Surgery, 230 subjects will be randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or chemotherapy and placebo).
Test Drug
Oregovomab
Active Ingredient
Oregovomab (MAb-B43.13)
Dosage Form
Lyophilized Powder for Solution for IV injection
Dosage
2 mg
Endpoints
Primary Outcome Measures :
Investigator Assessed Progression Free Survival [ Time Frame: Date of randomization until date of first documented disease progression or date of death from any cause, whichever comes first, at up to approximately 4 years. ]
Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or death
Secondary Outcome Measures :
Overall Survival [ Time Frame: Date of randomization up until date of death from any cause, up to approximately 8 years ]
Date of randomization to the date of death
Investigator Assessed Progression Free Survival [ Time Frame: Date of randomization until date of first documented disease progression or date of death from any cause, whichever comes first, at up to approximately 4 years. ]
Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or death
Secondary Outcome Measures :
Overall Survival [ Time Frame: Date of randomization up until date of death from any cause, up to approximately 8 years ]
Date of randomization to the date of death
Inclution Criteria
Major Inclusion Criteria:
Adults 18 years old or older.
Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease.
Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator). Debulking surgery must be optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor).
Preoperative serum CA- 125 levels ≥ 50 U/mL.
Adequate bone marrow function:
Absolute neutrophil count (ANC) greater than or equal to 1,500/µL
Platelets greater than or equal to100,000/µL
Hemoglobin greater than or equal to 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).
Adequate liver function:
Bilirubin < 1.5 times upper limit normal (ULN)
Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
Albumin >3.5 g/dL
Adequate renal function:
a. Creatinine less than or equal to1.5 times ULN
ECOG Performance Status of 0 or 1.
Adults 18 years old or older.
Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease.
Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator). Debulking surgery must be optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor).
Preoperative serum CA- 125 levels ≥ 50 U/mL.
Adequate bone marrow function:
Absolute neutrophil count (ANC) greater than or equal to 1,500/µL
Platelets greater than or equal to100,000/µL
Hemoglobin greater than or equal to 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).
Adequate liver function:
Bilirubin < 1.5 times upper limit normal (ULN)
Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
Albumin >3.5 g/dL
Adequate renal function:
a. Creatinine less than or equal to1.5 times ULN
ECOG Performance Status of 0 or 1.
Exclusion Criteria
Major Exclusion Criteria:
BRCA1 or BRCA2 germline gene mutation test result with:
Positive, ambiguous or inconclusive result available within 28 days prior to starting study treatment, or
Known BRCA1 and BRCA2 somatic mutations, and known positive germline, or
Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy.
Subjects with mucinous adenocarcinoma and low- grade adenocarcinoma.
Female subjects who are lactating and breastfeeding, or have a positive serum pregnancy test within 7 days prior to the first dose of study treatment (C1D1 for Cohort 1 or C4D1 for Cohort 2).
Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing spondylitis requiring active disease modifying treatment.
Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin.
Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc. (see Appendix G).
Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper. (Note: Premedication with corticosteroids per institutional standard of care is allowed.)
Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
Anticipated treatment with any other anti-cancer medications, including bevacizumab, poly (ADP- ribose) polymerase (PARP) inhibitors, or any investigational agent(s) during the study.
BRCA1 or BRCA2 germline gene mutation test result with:
Positive, ambiguous or inconclusive result available within 28 days prior to starting study treatment, or
Known BRCA1 and BRCA2 somatic mutations, and known positive germline, or
Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy.
Subjects with mucinous adenocarcinoma and low- grade adenocarcinoma.
Female subjects who are lactating and breastfeeding, or have a positive serum pregnancy test within 7 days prior to the first dose of study treatment (C1D1 for Cohort 1 or C4D1 for Cohort 2).
Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing spondylitis requiring active disease modifying treatment.
Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin.
Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc. (see Appendix G).
Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper. (Note: Premedication with corticosteroids per institutional standard of care is allowed.)
Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
Anticipated treatment with any other anti-cancer medications, including bevacizumab, poly (ADP- ribose) polymerase (PARP) inhibitors, or any investigational agent(s) during the study.
The Estimated Number of Participants
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Taiwan
28 participants
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Global
878 participants
