ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : May 14, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Fallopian Tubes Cancer
Ovarian Cancer
Peritoneal Cancer
Intervention: Biological: bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821
STARTED   22 
COMPLETED   21 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
   Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Years]
Median (Full Range)
 56 
 (49 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      22 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      22 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      22 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   22 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 1 year ]

2.  Secondary:   Immunogenicity (>/=3 Antigens) of the Vaccine   [ Time Frame: 1 year ]

3.  Secondary:   Progression-free Survival as Assessed By Multiplex Biomarker Panel of Angiogenesis Markers   [ Time Frame: Up to 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Paul Sabbatini, MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-4016
e-mail: sabbatip@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01223235     History of Changes
Other Study ID Numbers: 10-099
First Submitted: October 14, 2010
First Posted: October 18, 2010
Results First Submitted: March 16, 2018
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018