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, 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).
Eligibility 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.
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.
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There are 104 Locations for this study
Phoenix Arizona, 85016, United States More Info
Principal Investigator
La Jolla California, 92093, United States More Info
Principal Investigator
Pleasant Hill California, 94523, United States More Info
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Sacramento California, 95817, United States More Info
Walnut Creek California, 94598, United States More Info
Littleton Colorado, 80120, United States More Info
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Saint Petersburg Florida, 33701, United States More Info
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Savannah Georgia, 31405, United States More Info
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Honolulu Hawaii, 96813, United States More Info
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Honolulu Hawaii, 96826, United States More Info
Arlington Heights Illinois, 60005, United States More Info
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Oak Lawn Illinois, 60453, United States More Info
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Covington Louisiana, 70433, United States More Info
Boston Massachusetts, 02111, United States More Info
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Framingham Massachusetts, 01702, United States More Info
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Lowell Massachusetts, 01854, United States More Info
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Stoneham Massachusetts, 02180, United States More Info
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Coon Rapids Minnesota, 55433, United States More Info
Maple Grove Minnesota, 55369, United States More Info
Saint Louis Park Minnesota, 55416, United States More Info
New Brunswick New Jersey, 08903, United States More Info
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New York New York, 10011, United States More Info
Cleveland Ohio, 44111, United States More Info
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Cleveland Ohio, 44195, United States More Info
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Columbus Ohio, 43026, United States More Info
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Mayfield Heights Ohio, 44124, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
Tulsa Oklahoma, 74146, United States More Info
Eugene Oregon, 97401, United States More Info
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Portland Oregon, 97227, United States More Info
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Philadelphia Pennsylvania, 19104, United States More Info
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Pittsburgh Pennsylvania, 15224, United States More Info
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Pittsburgh Pennsylvania, 15237, United States More Info
West Reading Pennsylvania, 19611, United States
Austin Texas, 78731, United States More Info
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Bedford Texas, 76022, United States More Info
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Dallas Texas, 75231, United States More Info
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Houston Texas, 77030, United States More Info
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San Antonio Texas, 78240, United States More Info
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Temple Texas, 76508, United States
Charlottesville Virginia, 22903, United States More Info
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Fairfax Virginia, 21055, United States More Info
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Norfolk Virginia, 23502, United States More Info
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Gig Harbor Washington, 98335, United States More Info
Puyallup Washington, 98372, United States More Info
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Wilrijk Antwerp, , Belgium
Edegem , , Belgium More Info
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Blumenau , , Brazil More Info
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Porto Alegre , , Brazil More Info
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Rio De Janeiro , , Brazil More Info
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San Paolo , , Brazil More Info
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Santo André , , Brazil More Info
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Sao Paulo , , Brazil More Info
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Sao Paulo , , Brazil More Info
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Sao Paulo , , Brazil More Info
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São Paulo , , Brazil More Info
Montréal Quebec, H2X 3, Canada More Info
Montréal Quebec, H4A 3, Canada More Info
Montréal Quebec, , Canada More Info
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Praha , , Czechia More Info
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Praha , , Czechia More Info
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Budapest , , Hungary More Info
Zalaegerszeg , , Hungary More Info
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Chieti , , Italy More Info
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Seoul , , Korea, Republic of More Info
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Orizaba Veracruz, , Mexico More Info
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La Paz , 23040, Mexico More Info
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Mexico , , Mexico More Info
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Monterrey , , Mexico More Info
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Querétaro , , Mexico More Info
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San Luis Potosi , , Mexico More Info
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Lublin , , Poland More Info
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Olsztyn , , Poland More Info
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Siedlce , , Poland More Info
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Łódź , 93-33, Poland More Info
Cluj-Napoca , , Romania More Info
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Craiova , , Romania More Info
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Floreşti , , Romania More Info
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Timişoara , , Romania
Barcelona , , Spain More Info
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Madrid , , Spain
Sevilla , , Spain More Info
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