Ovarian Cancer Clinical Trial
Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery
Summary
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.
Full Description
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, approximately 372 subjects randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or chemotherapy with placebo). For Cohort 2 - NACT + Interval Surgery, approximately 230 subjects will be randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or chemotherapy and placebo).
Eligibility Criteria
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 less than 1 cm in diameter, or R0, microscopic or no evidence of tumor). Assessment of debulking surgery will be determined at the time of the surgical procedure, not by post-surgical imaging.
For Cohort 1, subject will undergo primary debulking surgery. Subject must receive initial dose of paclitaxel 175 mg/m^2 given intravenously and carboplatin AUC 6 IV every 3 weeks for 6 cycles. Carboplatin total dose given as 5 consecutive daily pulse doses, for subjects who experiences significant grade 3 or higher emesis. Subsequent dose modifications will be instituted per protocol. Cycle 1 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after primary debulking surgery
For Cohort 2, subject will undergo interval debulking surgery (IDS). Prior to IDS, subjects must have receive 3 cycles of paclitaxel and carboplatin as neoadjuvant treatment. After IDS, subjects must receive paclitaxel 175 mg/m^2 IV and carboplatin AUC 5-6 IV every 3 weeks, starting cycle 4. Cycle 4 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after IDS.
Suitable venous access for the study-required procedures
Preoperative serum CA-125 levels ≥ 50 U/mL for Cohort 1, serum CA-125 levels ≥ 50 U/mL prior to first neoadjuvant chemotherapy for Cohort 2.
Adequate bone marrow function:
Absolute neutrophil count (ANC) ≥ 1,500/µL
Platelets ≥ 100,000/µL
Hemoglobin ≥ 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
Adequate renal function:
a. Creatinine ≤ 1.5 times ULN
ECOG Performance Status of 0 or 1.
For women of childbearing potential, must be willing to avoid pregnancy by using highly effective method of contraception from the first dose of study treatment to 6 months after last dose of study treatment as defined per protocol. Belgium and South Korea only: Use of a highly effective method of contraception from 28 days before first dose.
Signed informed consent and authorization permitting release of personal health information.
Willingness and ability to complete patient quality of life questionnaires.
Exclusion Criteria:
BRCA1 or BRCA2 germline gene mutation test result with:
Pathogenic, ambiguous or inconclusive result available within 28 days prior to starting study treatment (subjects with BRCA1 or BRCA 2 variants of uncertain significance can enroll onto the study as long as there is no intent to administer PARP inhibitors for front-line maintenance therapy), or
Known BRCA1 and BRCA2 somatic mutations, if testing is performed
Known Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy. Subjects with somatic HRD are eligible as long as there is no intent to administer PARP inhibitor front-line maintenance therapy.
Subjects with mucinous adenocarcinoma, carcinosarcoma, tumors with neuroendocrine features 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).
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
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.
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.
Clinically significant active infection(s) at the time of screening.
Any of the following conditions (on-study testing is not required unless it is required by a specific participating country):
Known HIV-infected subjects unless on effective anti-retroviral therapy with an undetectable viral load within 6 months, or
Known or suspected hepatitis B if active infection (subjects 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
Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load).
Uncontrolled or life-threatening diseases compromising safety evaluation.
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 including ductal carcinoma in situ of the breast. Subjects with non-melanoma skin cancer, other carcinoma in situ if have undergone complete resection or cervix carcinoma in situ are not excluded if they have undergone complete resection. Synchronous endometrial and 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, and not poorly differentiated subtypes including papillary serous, clear cell lesions.
Contraindications to the use of pressor agents.
Undergone more than one surgical debulking or have not recovered from surgery.
Anticipated treatment with any other anti-cancer medications, including bevacizumab, PARP inhibitors, or any investigational agent(s) during the study.
History or evidence upon physical examination of CNS disease, seizures not controlled with standard medical therapy, or any brain metastases.
Any of the following cardiovascular conditions:
Acute myocardial infarction within 6 months before the first dose of study treatment.
Current history of New York Heart Association (NYHA) Class III or IV heart failure.
Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic clinically significant findings.
Unable to read or understand or unable to sign the necessary written consent before starting treatment.
May not receive any live, attenuated vaccine administered within 28 days (or 4 weeks) prior to enrollment, during the study, and for at least 90 days after the last dose of study treatment.
Subjects who receive Hyperthermic Intraperitoneal Chemotherapy (HIPEC), any other anti-cancer medications, including bevacizumab, PARP inhibitors, or any other investigational agent(s) with 3 cycles of paclitaxel and carboplatin neoadjuvant treatment prior to IDS.
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There are 93 Locations for this study
Phoenix Arizona, 85016, United States
Tucson Arizona, 85724, United States
Concord California, 94520, United States
Irvine California, 92120, United States
La Jolla California, 92093, United States
Los Angeles California, 90027, United States
Pleasant Hill California, 94523, United States
Riverside California, 95505, United States
Sacramento California, 95817, United States
Walnut Creek California, 94598, United States
Walnut Creek California, 94598, United States
Aurora Colorado, 80045, United States
Farmington Connecticut, 06030, United States
New Haven Connecticut, 06510, United States
New Haven Connecticut, 06510, United States
Orlando Florida, 32804, United States
Saint Petersburg Florida, 33701, United States
Savannah Georgia, 31405, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96826, United States
Fort Wayne Indiana, 46845, United States
Covington Louisiana, 70433, United States
Boston Massachusetts, 02111, United States
Burlington Massachusetts, 01805, United States
Framingham Massachusetts, 01702, United States
Lowell Massachusetts, 01854, United States
Stoneham Massachusetts, 02180, United States
Worcester Massachusetts, 01605, United States
Ann Arbor Michigan, 48106, United States
Lansing Michigan, 48219, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Maple Grove Minnesota, 55369, United States
Minneapolis Minnesota, 55404, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55426, United States
Saint Paul Minnesota, 55102, United States
Omaha Nebraska, 68114, United States
Portsmouth New Hampshire, 03801, United States
New Brunswick New Jersey, 08903, United States
Paramus New Jersey, 07450, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
Lake Success New York, 10019, United States
New York New York, 10011, United States
New York New York, 10029, United States
Stony Brook New York, 11794, United States
Durham North Carolina, 27710, United States
Raleigh North Carolina, 27607, United States
Chardon Ohio, 44024, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43026, United States
Kettering Ohio, 45429, United States
Mayfield Heights Ohio, 44124, United States
Orange Village Ohio, 44122, United States
Westlake Ohio, 44145, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97227, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15224, United States
Pittsburgh Pennsylvania, 15237, United States
Providence Rhode Island, 02905, United States
Sioux Falls South Dakota, 57104, United States
Austin Texas, 78731, United States
Dallas Texas, 75231, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
San Antonio Texas, 78240, United States
Charlottesville Virginia, 22903, United States
Fairfax Virginia, 21055, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23298, United States
Roanoke Virginia, 24106, United States
Auburn Washington, 98001, United States
Gig Harbor Washington, 98335, United States
Puyallup Washington, 98372, United States
Tacoma Washington, 98405, United States
Madison Wisconsin, 53792, United States
Córdoba Cordoba, 2941, Argentina
Córdoba Cordoba, , Argentina
Rosario , 2000, Argentina
Salta , 4400, Argentina
San Juan , , Argentina
Viedma , R8500, Argentina
Antwerpen , , Belgium
Bruxelles , , Belgium
Liège , , Belgium
Blumenau , , Brazil
Guimaraes , , Brazil
Porto Alegre , , Brazil
San Paolo , , Brazil
Santo André , , Brazil
Sao Paulo , , Brazil
Halifax Nova Scotia, B3H 2, Canada
Laval Quebec, H7M 3, Canada
Montréal Quebec, H2X 3, Canada
Montréal Quebec, H4A 3, Canada
Montréal Quebec, , Canada
Sherbrooke Quebec, J1H 5, Canada
Santiago , , Chile
Temuco , , Chile
Hradec Kralove , 500 0, Czechia
Olomouc , , Brazil
Sao Paulo , , Brazil
São Paulo , , Brazil
Halifax Nova Scotia, B3H 2, Canada
Laval Quebec, H7M 3, Canada
Montréal Quebec, H2X 3, Canada
Montréal Quebec, H4A 3, Canada
Montréal Quebec, , Canada
Sherbrooke Quebec, J1H 5, Canada
Santiago , , Chile
Santiago , , Chile
Temuco , , Chile
ValparaÃso , , Chile
Hradec Kralove , 500 0, Czechia
Olomouc , , Czechia
Prague , , Czechia
Praha , , Czechia
Praha , , Czechia
Praha , , Czechia
Budapest , , Hungary
Budapest , , Hungary
Budapest , , Hungary
Debrecen , , Hungary
Kecskemét , , Hungary
Zalaegerszeg , , Hungary
Bangalore , , India
Bengaluru , , India
Delhi , , India
Mohali , , India
Mumbai , , India
New Delhi , , India
Noida , , India
Pune , , India
Pune , , India
Chieti , , Italy
Monza , , Italy
Rome , 00168, Italy
Rome , , Italy
Goyang , , Korea, Republic of
Seongnam , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Soeul , , Korea, Republic of
Orizaba Veracruz, , Mexico
La Paz , 23040, Mexico
Mexico , , Mexico
Monterrey , , Mexico
Querétaro , , Mexico
San Luis Potosi , , Mexico
Olsztyn , , Poland
Siedlce , , Poland
Cluj-Napoca , , Romania
FloreÅŸti , , Romania
Barcelona Catalonia, , Spain
Barcelona Catalonia, , Spain
Barcelona , , Spain
Granada , , Spain
L'Hospitalet De Llobregat , , Spain
Madrid , , Spain
Madrid , , Spain
Sevilla , , Spain
Valencia , , Spain
Taipei county Taipei, , Taiwan
Taichung , , Taiwan
Taichung , , Taiwan
Tainan , 70457, Taiwan
Taipei , , Taiwan
Taipei , , Taiwan
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