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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2020-002270-26
    Sponsor's Protocol Code Number:QPT-ORE-005
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-20
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2020-002270-26
    A.3Full title of the trial
    A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma
    Dvojitě zaslepené, placebem kontrolované, multicentrické klinické hodnocení fáze 3 porovnávající chemoimunoterapii (paklitaxel-karboplatina-oregovomab) oproti chemoterapii (paklitaxel-karboplatina-placebo) u pacientek s pokročilým epiteliálním karcinomem vaječníku, karcinomem vejcovodu nebo peritoneálním karcinomem.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing Paclitaxel-Carboplatin-Oregovomab versus Paclitaxel-Carboplatin-Placebo in Patients with Advanced Ovarian Cancer
    A.4.1Sponsor's protocol code numberQPT-ORE-005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04498117
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOncoQuest Pharmaceuticals Inc.
    B.1.3.4CountryKorea, Republic of
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOncoQuest Pharmaceuticals Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOncoQuest Pharmaceuticals Inc.
    B.5.2Functional name of contact pointClinical Trial Disclosures Desk
    B.5.3 Address:
    B.5.3.1Street Address670-21 Sannae-ro
    B.5.3.2Town/ citySannae-myeon, Miryang-Si
    B.5.3.3Post code50414
    B.5.3.4CountryKorea, Republic of
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOREGOVOMAB
    D.3.2Product code MAB-B43.13
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOregovomab
    D.3.9.1CAS number 213327-37-8
    D.3.9.2Current sponsor codeMAb-B43.13
    D.3.9.3Other descriptive nameMonoclonal antibody B43.13
    D.3.9.4EV Substance CodeSUB192482
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    advanced epithelial ovarian, fallopian tube or peritoneal carcinoma
    E.1.1.1Medical condition in easily understood language
    ovarian and associated cancers
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Progression-free survival (PFS):
    To determine the efficacy by progression free survival (using investigator assessment of scans according to RECIST v1.1) of oregovomab compared to placebo when administered with chemotherapy (paclitaxel/carboplatin) to subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery
    E.2.2Secondary objectives of the trial
    - To determine the efficacy by overall survival of oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) to subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery

    - To assess the safety and tolerability of oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) to subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery

    - To evaluate the effects of treatment with oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) on Health-related Quality of Life (HRQoL) as assessed by trial outcome index (TOI) of the Functional Assessment of Cancer Therapy – Ovarian (FACT-O) and 3 additional questions from the NFOSI-18 in subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults 18 years old or older.
    2. Subjects with newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease.
    3. Eligible 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.).
    4. Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator), as defined below:
    a. For subjects who undergo primary debulking surgery (Cohort 1 - Primary Surgery):
    i. Cycle 1 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after primary debulking surgery, and
    ii. The primary debulking surgery is optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor).
    b. For subjects who will undergo interval debulking surgery (Cohort 2 – NACT/Interval Surgery):
    i. Subject must have received neoadjuvant treatment with 3 cycles of paclitaxel 175 mg/m2 IV over 3 hours every approximately 3 weeks (21 Days), followed by carboplatin area under the curve (AUC) 5-6 administered intravenously (IV) approximately every 3 weeks (21 Days), and
    ii. Cycle 4 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after interval debulking surgery, and
    iii. The interval debulking surgery is optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor).
    5. Suitable venous access for the study-required procedures.
    6. Cohort 1 – Primary Surgery: Preoperative serum CA-125 levels ≥ 50 U/mL, or in Cohort 2 – NACT + Interval Surgery: serum CA-125 levels ≥ 50 U/mL prior to first pre-operative chemotherapy.
    7. Adequate bone marrow function:
    a. Absolute neutrophil count (ANC) ≥ 1,500/μL
    b. Platelets ≥ 100,000/μL
    c. Hemoglobin ≥ 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).
    8. Adequate liver function:
    a. Bilirubin < 1.5 times upper limit normal (ULN)
    b. Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
    c. Albumin >3.5 g/dL
    9. Adequate renal function:
    a. Creatinine ≤ 1.5 times ULN
    10. ECOG Performance Status of 0 or 1.
    11. For women of childbearing potential, must be willing to avoid pregnancy by using a highly effective method of contraception from the first dose of study treatment to 60 days after last dose of study treatment. Adequate contraception is defined in Section 8.2.5.
    12. Sign informed consent and authorization permitting release of personal health information.
    13. Willingness and ability to complete patient quality of life questionnaires.
    E.4Principal exclusion criteria
    1. BRCA1 or BRCA2 germline gene mutation test result with:
    a. Positive, ambiguous or inconclusive result available within 28 days prior to starting study treatment, or
    b. Known BRCA1 and BRCA2 somatic mutations, and known positive germline, or
    c. Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy.
    2. Subjects with mucinous adenocarcinoma and low-grade adenocarcinoma.
    3. 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).
    4. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
    5. 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.
    6. Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin.
    7. Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc. (see Appendix G).
    8. 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.)
    9. Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
    10. Clinically significant active infection(s) at the time of screening.
    11. Any of the following conditions (on-study testing is not required):
    a. Known HIV-infected subjects unless on effective anti-retroviral therapy with an undetectable viral load within 6 months, or
    b. Known or suspected hepatitis B if active infection (patients with chronic hepatitis B infection must have an undetectable HBV viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion), or
    c. Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load).
    12. Uncontrolled or life-threatening diseases compromising safety evaluation.
    13. Diagnosed or treated for another malignancy within 5 years before the first dose, or previously diagnosed with another malignancy and have any evidence of residual disease. Subjects with non-melanoma skin cancer or cervix carcinoma in situ are not excluded if they have undergone complete resection. Synchronous endometrial cancer, but a prior diagnosis of endometrial cancer within 5 years is not excluded if all of the following conditions are met: Stage IA, superficial myometrial invasion, without lymphovascular invasion, grade 3 or not poorly differentiated subtypes including papillary serous, clear cell or other FIGO Grade 3 lesions.
    14. Contraindications to the use of pressor agents.
    15. Undergone more than one surgical debulking or have not recovered from surgery.
    16. Anticipated treatment with any other anti-cancer medications, including bevacizumab, poly (ADP-ribose) polymerase (PARP) inhibitors, or any investigational agent(s) during the study.
    17. History or evidence upon physical examination of CNS disease, seizures not controlled with standard medical therapy, or any brain metastases.
    18. Any of the following cardiovascular conditions:
    a. Acute myocardial infarction within 6 months before the first dose of study treatment.
    b. Current history of New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H).
    c. Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic clinically significant findings.
    19. Unable to read or understand or unable to sign the necessary written consent before starting treatment.
    E.5 End points
    E.5.1Primary end point(s)
    PFS, defined as date of randomization which occurs following surgery to the date of event defined as the first documented progression as per RECIST v1.1 as determined by the investigator or death due to any cause
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of disease progression as determined by the investigator (in conjunction with the local radiologist) or date of death.
    E.5.2Secondary end point(s)
    - OS, defined as date of randomization to date of death due to any cause
    - Frequency/ severity of vital signs measurements, physical examination findings, changes in clinical laboratory parameters (hematology, biochemistry, urinalysis), and incidence of adverse events (AEs) – including AEs, serious AEs (SAEs), deaths, and AEs leading to discontinuation of treatment
    - Change from baseline in the global health status/QOL scale score of the Functional Assessment of Cancer Therapy-Ovary (FACT-O TOI) and 3 additional questions from the NFOSI-18 in each treatment group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival will be calculated from the date of randomization which occurs following primary or interval surgery prior to Cycle 1 in Cohort 1 – Primary Surgery and prior to Cycle 4 in Cohort 2 – NACT + Interval Surgery to the date of death. Subjects who are alive at the time of analysis of the primary endpoint, or who withdraw consent or are lost to follow-up, will be censored at the day they were last known to be alive.

    QOL scale score:
    Overall score, sub-scores, and individual items will be summarized and compared between treatment groups by cohort. The primary analysis will be based on overall score from baseline through month 36, with other measurements considered supportive.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Republic of
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study overall is defined as five years after the date of the last follow-up visit of the last subject who entered the follow-up period, or at sponsor’s decision to end the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 482
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 103
    F.4.2.2In the whole clinical trial 602
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects will enter the Post-Treatment Follow Up Period (Safety Follow-up, Progression Follow-up, Survival Follow-up).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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