Trial Outcomes & Findings for Trivalent Ganglioside Vaccine With Immunological Adjuvant or Immunological Adjuvant Alone in Metastatic Sarcoma Patients Who Are Rendered Disease Free (NCT NCT01141491)
NCT ID: NCT01141491
Last Updated: 2017-04-12
Results Overview
The primary objective is to compare the progression-free survival (PFS) over time. Progression free survival is defined as the time from randomization until any evidence of tumor growth or appearance anywhere in the body or death from any cause as determined by the principal investigator at each site. The principal investigator will determine Progression-free survival by using CT scans to evaluate disease recurrence. For the purpose of this study, progression of disease is defined as the development of tumor growth or recurrence at any site of the body as determined by the principal investigator at each study site or death from disease
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
3-years
Results posted on
2017-04-12
Participant Flow
Participant milestones
| Measure |
Arm A- Vaccine Plus OPT-821
Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
|
Arm B - OPT-821 Immunologic Adjuvant
Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
48
|
47
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trivalent Ganglioside Vaccine With Immunological Adjuvant or Immunological Adjuvant Alone in Metastatic Sarcoma Patients Who Are Rendered Disease Free
Baseline characteristics by cohort
| Measure |
Arm A- Vaccine Plus OPT-821
n=68 Participants
Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
|
Arm B - OPT-821 Immunologic Adjuvant
n=68 Participants
OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-yearsThe primary objective is to compare the progression-free survival (PFS) over time. Progression free survival is defined as the time from randomization until any evidence of tumor growth or appearance anywhere in the body or death from any cause as determined by the principal investigator at each site. The principal investigator will determine Progression-free survival by using CT scans to evaluate disease recurrence. For the purpose of this study, progression of disease is defined as the development of tumor growth or recurrence at any site of the body as determined by the principal investigator at each study site or death from disease
Outcome measures
| Measure |
Arm A- Vaccine Plus OPT-821
n=68 Participants
Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
|
Arm B - OPT-821 Immunologic Adjuvant
n=68 Participants
Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
|
|---|---|---|
|
Progression Free Survival
|
186 Days
Interval 163.0 to 193.0
|
271 Days
Interval 186.0 to 273.0
|
SECONDARY outcome
Timeframe: Measured over timeTo compare the overall survival over time, to estimate the median and 3-year progression-free survival.
Outcome measures
Outcome data not reported
Adverse Events
Arm A- Vaccine Plus OPT-821
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm B - OPT-821 Immunologic Adjuvant
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A- Vaccine Plus OPT-821
n=68 participants at risk
Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
|
Arm B - OPT-821 Immunologic Adjuvant
n=68 participants at risk
OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.5%
1/68 • Number of events 1 • 3 years
|
0.00%
0/68 • 3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/68 • 3 years
|
1.5%
1/68 • Number of events 1 • 3 years
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/68 • 3 years
|
1.5%
1/68 • Number of events 1 • 3 years
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/68 • 3 years
|
1.5%
1/68 • Number of events 1 • 3 years
|
|
Immune system disorders
Anaphylactoid reaction
|
1.5%
1/68 • Number of events 1 • 3 years
|
0.00%
0/68 • 3 years
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.5%
1/68 • Number of events 1 • 3 years
|
0.00%
0/68 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/68 • 3 years
|
1.5%
1/68 • Number of events 1 • 3 years
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/68 • 3 years
|
1.5%
1/68 • Number of events 1 • 3 years
|
|
General disorders
Death
|
1.5%
1/68 • Number of events 1 • 3 years
|
0.00%
0/68 • 3 years
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/68 • 3 years
|
1.5%
1/68 • Number of events 1 • 3 years
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/68 • 3 years
|
1.5%
1/68 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/68 • 3 years
|
1.5%
1/68 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Arm A- Vaccine Plus OPT-821
n=68 participants at risk
Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
|
Arm B - OPT-821 Immunologic Adjuvant
n=68 participants at risk
OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
|
|---|---|---|
|
Infections and infestations
Ear infection
|
1.5%
1/68 • Number of events 1 • 3 years
|
0.00%
0/68 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site shall withhold publication of Site's individual Study results for a period of 18 months following completion of the Study at all sites, or until after Sponsor's written confirmation that Sponsor will not publish a joint, multicenter publication, whichever occurs first.
- Publication restrictions are in place
Restriction type: OTHER