Polyvalent Vaccine-KLH Conjugate + Opt-821 Given in Combination With Bevacizumab
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01223235|
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : May 14, 2018
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tubes Cancer Ovarian Cancer Peritoneal Cancer||Biological: bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PILOT STUDY OF A POLYVALENT VACCINE-KLH CONJUGATE + OPT-821 GIVEN IN COMBINATION WITH BEVACIZUMAB IN PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN SECOND OR GREATER COMPLETE OR PARTIAL CLINICAL REMISSION|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Experimental: bevacizumab & polyvalent vaccine-KLH conjugate + OPT-821
This is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Biological: bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821
A maximum of 6 doses of the polyvalent-KLH vaccine and OPT-821 will be administered to each patient as per the schedule. Bevacizumab will be administered once every two weeks until week 11 and then once every three weeks according to the schedule. When the 6 vaccinations of the polyvalent-KLH vaccine +OPT821 are completed, patients may still continue to receive bevacizumab on the once every three week schedule.
- Number of Participants With Adverse Events [ Time Frame: 1 year ]Toxicities evaluated by CTCAE version 4.0
- Percentage of Participants Who Met the Immunogenicity Criteria (>/=3 Antigens) of the Vaccine [ Time Frame: 1 year ]
when given in the presence of bevacizumab
Patients must have IgM titer >1:80, or a fourfold increase in prevailing antibody titer if present at baseline. Twenty-one patients would be accrued, and if >8 of 21 patients should meet these criteria for three or more antigens based on the immune response criteria, the study would be considered positive.
- Progression-free Survival as Assessed By Multiplex Biomarker Panel of Angiogenesis Markers [ Time Frame: Up to 24 months ]Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5mm.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223235
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Paul Sabbatini, MD||Memorial Sloan Kettering Cancer Center|