Trial Outcomes & Findings for Vaccination Plus Ontak in Patients With Metastatic Melanoma (NCT NCT00515528)
NCT ID: NCT00515528
Last Updated: 2021-01-26
Results Overview
Proportion of Patients With a Best Response of Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). Response was evaluated every 6 weeks based on Response Evaluation In Solid Tumor (RECIST) version 1.1. Per RECIST v1.1 for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-01-26
Participant Flow
Participant milestones
| Measure |
Vaccine Alone
Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression.
|
Vaccine Plus Ontak
Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccination Plus Ontak in Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Vaccine Alone
n=10 Participants
Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression.
|
Vaccine Plus Ontak
n=7 Participants
Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
63 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksProportion of Patients With a Best Response of Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). Response was evaluated every 6 weeks based on Response Evaluation In Solid Tumor (RECIST) version 1.1. Per RECIST v1.1 for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Outcome measures
| Measure |
Vaccine Alone
n=10 Participants
Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression.
|
Vaccine Plus Ontak
n=7 Participants
Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration.
|
|---|---|---|
|
Clinical Response Outcome
PR
|
1 Participants
|
0 Participants
|
|
Clinical Response Outcome
SD
|
4 Participants
|
4 Participants
|
|
Clinical Response Outcome
PD
|
5 Participants
|
3 Participants
|
Adverse Events
Vaccine Alone
Serious events: 2 serious events
Other events: 10 other events
Deaths: 1 deaths
Vaccine Plus Ontak
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Vaccine Alone
n=10 participants at risk
Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression.
|
Vaccine Plus Ontak
n=7 participants at risk
Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration.
|
|---|---|---|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • 3 months
|
0.00%
0/7 • 3 months
|
|
General disorders
Chest pain
|
10.0%
1/10 • 3 months
|
0.00%
0/7 • 3 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
Congenital, familial and genetic disorders
Pericardial tamponade
|
0.00%
0/10 • 3 months
|
14.3%
1/7 • 3 months
|
Other adverse events
| Measure |
Vaccine Alone
n=10 participants at risk
Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression.
|
Vaccine Plus Ontak
n=7 participants at risk
Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration.
|
|---|---|---|
|
General disorders
Injection Site Pain
|
70.0%
7/10 • 3 months
|
42.9%
3/7 • 3 months
|
|
General disorders
Headache
|
90.0%
9/10 • 3 months
|
28.6%
2/7 • 3 months
|
|
General disorders
Fatigue
|
10.0%
1/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • 3 months
|
28.6%
2/7 • 3 months
|
|
General disorders
Fever
|
10.0%
1/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • 3 months
|
42.9%
3/7 • 3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • 3 months
|
28.6%
2/7 • 3 months
|
|
Infections and infestations
Infection
|
0.00%
0/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
40.0%
4/10 • 3 months
|
57.1%
4/7 • 3 months
|
|
Investigations
SGOT
|
10.0%
1/10 • 3 months
|
28.6%
2/7 • 3 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
Investigations
SGPT
|
30.0%
3/10 • 3 months
|
42.9%
3/7 • 3 months
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
General disorders
Chills
|
20.0%
2/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
Investigations
Absolute Neutrophil Count Decrease
|
0.00%
0/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
Investigations
Platelet Count Decreased
|
10.0%
1/10 • 3 months
|
0.00%
0/7 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
10.0%
1/10 • 3 months
|
0.00%
0/7 • 3 months
|
|
General disorders
Insomnia
|
10.0%
1/10 • 3 months
|
0.00%
0/7 • 3 months
|
|
Investigations
Creatinine Increased
|
20.0%
2/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
Investigations
Bilirubin increased
|
20.0%
2/10 • 3 months
|
0.00%
0/7 • 3 months
|
|
Nervous system disorders
Neurological
|
30.0%
3/10 • 3 months
|
0.00%
0/7 • 3 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • 3 months
|
0.00%
0/7 • 3 months
|
|
General disorders
Visual Problems
|
0.00%
0/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
General disorders
Neck Tightness
|
10.0%
1/10 • 3 months
|
0.00%
0/7 • 3 months
|
|
Nervous system disorders
Edema
|
0.00%
0/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
General disorders
Weight Gain
|
0.00%
0/10 • 3 months
|
14.3%
1/7 • 3 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • 3 months
|
28.6%
2/7 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place