A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT01616303|
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms||Drug: carboplatin & paclitaxel Biological: carboplatin & paclitaxel & oregovomab||Phase 2|
Oregovomab is an investigational drug previously used in clinical trials as an immunotherapeutic treatment of ovarian cancer patients whose tumor cells express the tumor associated antigen, CA125. The active component of oregovomab is the activated murine monoclonal antibody B43.13, an immunoglobulin G1k (IgG1k) subclass immunoglobulin that binds with high affinity (1.16E10/M) to CA125.
CA125 is a surface glycoprotein antigen that is expressed on more than 80% of all non-mucinous epithelial ovarian carcinomas where it occurs at elevated levels in the serum of patients with ovarian cancer. Little is known about its biological function. CA125 is associated with a large molecular weight mucin-like glycoprotein complex of 200-250 kilodaltons (kDa) and its genetic structure has recently been elucidated. There is good evidence to suggest that CA125 is a relevant target antigen for antigen-mediated immunotherapy of ovarian cancer.
The study will compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy (carboplatin and paclitaxel alone) in female patients with advanced ovarian cancer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2: A Randomized Controlled Study on Effectiveness of Chemotherapy (Carboplatin-Paclitaxel) Versus Chemo-immunotherapy (Carboplatin-Paclitaxel-Oregovomab) in Patients With Advanced Epithelial Ovarian, Adnexal or Peritoneal Carcinoma|
|Actual Study Start Date :||June 15, 2012|
|Actual Primary Completion Date :||June 15, 2015|
|Actual Study Completion Date :||October 12, 2018|
Active Comparator: carboplatin & paclitaxel
first-line chemotherapy for ovarian cancer
Drug: carboplatin & paclitaxel
carboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks [21 days]) plus paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks [21 days])
Experimental: carboplatin & paclitaxel & oregovomab
first-line chemotherapy for ovarian cancer plus oregovomab
Biological: carboplatin & paclitaxel & oregovomab
carboplatin (AUC 6, administered intravenously in a single day for 6 cycles every three weeks [21 days]) plus paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks [21 days]) plus oregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle).
- CA125 ELISPOT assay response for cytotoxic T cell antigen specific immunity induction to end of first-line chemotherapy [ Time Frame: At Baseline (up to 4 weeks before Cycle 1), at Cycle 5 (approximately 12 weeks after Cycle 1) and termination (approximately 25 weeks after Cycle 1) ]Change from baseline CA125 ELISPOT assay after stimulation with oregovomab (MAb-B43.13 against CA125) measured at approximately 12 weeks and 25 weeks after the start of first-line chemotherapy
- Time to clinical relapse [ Time Frame: Up to three years after treatment in the study ]The time period from the date of randomization to the date of confirmed relapse as defined by clinical, radiologic, and/or pathologic evaluations.
- Immune parameters: HAMA (human anti-mouse antibody) titers and DTH (delayed type hypersensitivity) [ Time Frame: Up to three years after treatment in the study ]Laboratory test for human anti-mouse antibody (HAMA) present in patients' sera. DTH (delayed type hypersensitivity) is an on-site test conducted by the investigator by injecting a small amount of the Oregovomab product and three other antigens (mumps, tetanus, and Candida) into the skin of the patient and observing the effects.
- Clinical response [ Time Frame: Up to three years after treatment in the study ]Patients will be categorized into one of the following: increasing disease, stable disease, or progression [measurable disease studies]
- Overall Survival [ Time Frame: Up to three years after treatment in the study ]The observed length of life from entry into the study to death or the date of last contact
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616303
|United States, Connecticut|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030|
|United States, Indiana|
|Northern Indiana Cancer Research Consortium|
|South Bend, Indiana, United States, 46601|
|Study Director:||Thomas Woo, M.Sc.||Quest PharmaTech Inc.|
|Study Chair:||Christopher Nicodemus, MD FACP||AIT Strategies|