Trial Outcomes & Findings for Polyvalent Vaccine-KLH Conjugate + Opt-821 Given in Combination With Bevacizumab (NCT NCT01223235)

NCT ID: NCT01223235

Last Updated: 2018-06-12

Results Overview

Toxicities evaluated by CTCAE version 4.0

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2018-06-12

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Polyvalent Vaccine-KLH Conjugate + Opt-821 Given in Combination With Bevacizumab

Baseline characteristics by cohort

Measure	Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821 n=22 Participants 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.
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Toxicities evaluated by CTCAE version 4.0

Outcome measures

Measure	Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821 n=21 Participants 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.
Number of Participants With Adverse Events	21 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821 n=21 Participants 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.
Percentage of Participants Who Met the Immunogenicity Criteria (>/=3 Antigens) of the Vaccine	68 % of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821 n=21 Participants 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.
Progression-free Survival as Assessed By Multiplex Biomarker Panel of Angiogenesis Markers	13 months (Progression Free Survival) Interval 10.0 to 20.0

Adverse Events

Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821

Serious events: 5 serious events

Other events: 21 other events

Deaths: 18 deaths

Serious adverse events

Measure	Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821 n=21 participants at risk 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.
Renal and urinary disorders Acute Kidney Injury	4.8% 1/21 • Until time to treatment failure, up to 20 months.
Cardiac disorders Chest pain - cardiac	4.8% 1/21 • Until time to treatment failure, up to 20 months.
Metabolism and nutrition disorders Dehydration	4.8% 1/21 • Until time to treatment failure, up to 20 months.
General disorders Fatigue	4.8% 1/21 • Until time to treatment failure, up to 20 months.
General disorders Fever	9.5% 2/21 • Until time to treatment failure, up to 20 months.
General disorders Injection site reaction	4.8% 1/21 • Until time to treatment failure, up to 20 months.
Renal and urinary disorders Urinary tract obstruction	4.8% 1/21 • Until time to treatment failure, up to 20 months.

Other adverse events

Measure	Bevacizumab & Polyvalent Vaccine-KLH Conjugate + OPT-821 n=21 participants at risk 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.
General disorders Injection site reaction	14.3% 3/21 • Until time to treatment failure, up to 20 months.
Nervous system disorders Headache	4.8% 1/21 • Until time to treatment failure, up to 20 months.
Metabolism and nutrition disorders Hyperglycemia	4.8% 1/21 • Until time to treatment failure, up to 20 months.
General disorders Fever	14.3% 3/21 • Until time to treatment failure, up to 20 months.
Investigations White blood cell decreased	9.5% 2/21 • Until time to treatment failure, up to 20 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.8% 1/21 • Until time to treatment failure, up to 20 months.
Vascular disorders Hypertension	14.3% 3/21 • Until time to treatment failure, up to 20 months.
Gastrointestinal disorders Nausea	4.8% 1/21 • Until time to treatment failure, up to 20 months.
Blood and lymphatic system disorders Anemia	4.8% 1/21 • Until time to treatment failure, up to 20 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.8% 1/21 • Until time to treatment failure, up to 20 months.
Investigations Blood bilirubin increased	4.8% 1/21 • Until time to treatment failure, up to 20 months.
Gastrointestinal disorders Diarrhea	4.8% 1/21 • Until time to treatment failure, up to 20 months.
Investigations Serum amylase increased	9.5% 2/21 • Until time to treatment failure, up to 20 months.
Metabolism and nutrition disorders Anorexia	4.8% 1/21 • Until time to treatment failure, up to 20 months.
Metabolism and nutrition disorders Hypophosphatemia	4.8% 1/21 • Until time to treatment failure, up to 20 months.

Additional Information

Dr. Paul Sabbatini, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-4016

Email: sabbatip@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place