Trial Outcomes & Findings for A Phase I Study With a Personalized NeoAntigen Cancer Vaccine in Melanoma (NCT NCT01970358)
NCT ID: NCT01970358
Last Updated: 2025-12-29
Results Overview
Number of participants experiencing any of the following: * Grade-3 or -4 toxicity that is definitely, probably, or possibly related to the administration of vaccine * Grade-3 or -4 abnormal laboratory value that is definitely, probably, or possibly related to the administration of vaccine if it persists for more than 7 days, requires hospitalization, or medical intervention * Any grade-3 or grade- 4 toxicity that is considered, in the opinion of the investigator, to be dose-limiting * Any death related to study treatment A minimum of 3 vaccinations and absence of DLTs are required for a patient to complete the 7-week DLT observation period successfully.
COMPLETED
PHASE1
15 participants
7 weeks from first study drug administration
2025-12-29
Participant Flow
Dates of recruitment: April 2014 through July 2016.
Participant consent/screening was conducted in two stages. Participants first had surgery with the intention to remove all melanoma. After confirmation of complete tumor resection by pathologic review and determination of adequacy of DNA and RNA from tumor tissue for sequencing, participants were reconsented for generation of the vaccine. Participants with tumors that were not completely resected and/or that provided inadequate DNA and/or RNA for sequencing were removed from the trial.
Participant milestones
| Measure |
Personalized NeoAntigen Cancer Vaccine
\- NeoVax (peptides + poly-ICLC)
Poly-ICLC: 4 x 0.5 mg (total dose 2 mg) given on days Days 1, 4, 8, 15, 22, 78, and 134
Peptides: 4 x 300 mcg per peptide given on days Days 1, 4, 8, 15, 22, 78, and 134
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Personalized NeoAntigen Cancer Vaccine
\- NeoVax (peptides + poly-ICLC)
Poly-ICLC: 4 x 0.5 mg (total dose 2 mg) given on days Days 1, 4, 8, 15, 22, 78, and 134
Peptides: 4 x 300 mcg per peptide given on days Days 1, 4, 8, 15, 22, 78, and 134
|
|---|---|
|
Overall Study
Unable to make NeoVax or NeoVax not viable
|
3
|
|
Overall Study
Ineligible at time of second consent
|
4
|
Baseline Characteristics
A Phase I Study With a Personalized NeoAntigen Cancer Vaccine in Melanoma
Baseline characteristics by cohort
| Measure |
Personalized NeoAntigen Cancer Vaccine
n=15 Participants
\- NeoVax (peptides + poly-ICLC)
Poly-ICLC: 4 x 0.5 mg (total dose 2 mg) given on days Days 1, 4, 8, 15, 22, 78, and 134
Peptides: 4 x 300 mcg per peptide given on days Days 1, 4, 8, 15, 22, 78, and 134
Poly-ICLC
Peptides
|
|---|---|
|
Age, Continuous
|
61 years
n=174 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=174 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=174 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
|
Melanoma AJCC Stage
IIIB
|
3 Participants
n=174 Participants
|
|
Melanoma AJCC Stage
IIIC
|
7 Participants
n=174 Participants
|
|
Melanoma AJCC Stage
IV M1a
|
3 Participants
n=174 Participants
|
|
Melanoma AJCC Stage
IV M1b
|
2 Participants
n=174 Participants
|
PRIMARY outcome
Timeframe: 7 weeks from first study drug administrationPopulation: Number of participants receiving NeoVax.
Number of participants experiencing any of the following: * Grade-3 or -4 toxicity that is definitely, probably, or possibly related to the administration of vaccine * Grade-3 or -4 abnormal laboratory value that is definitely, probably, or possibly related to the administration of vaccine if it persists for more than 7 days, requires hospitalization, or medical intervention * Any grade-3 or grade- 4 toxicity that is considered, in the opinion of the investigator, to be dose-limiting * Any death related to study treatment A minimum of 3 vaccinations and absence of DLTs are required for a patient to complete the 7-week DLT observation period successfully.
Outcome measures
| Measure |
Personalized NeoAntigen Cancer Vaccine
n=8 Participants
\- NeoVax (peptides + poly-ICLC)
Poly-ICLC: 4 x 0.5 mg (total dose 2 mg) given on days Days 1, 4, 8, 15, 22, 78, and 134
Peptides: 4 x 300 mcg per peptide given on days Days 1, 4, 8, 15, 22, 78, and 134
|
|---|---|
|
Number of Participants Experiencing Clinical and/or Laboratory Dose-limiting Toxicities
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Number of participants with complete resection and adequate DNA/RNA for sequencing.
The proportion of participants for whom sequencing and analysis leads to identification of at least 10 actionable peptides to initiate vaccine production. The primary assessment of feasibility will be based on on all participants enrolled with a confirmation of completely resected tumor and with adequate DNA and RNA for sequencing. NeoVax would be feasible if no more than 50% of participants have fewer than 10 actionable peptides or have NeoVax available more than 12 weeks after confirmation of complete resection. If 4 or fewer of the first 15 participants have insufficient vaccine or first dose delays of more than 12 weeks, then the upper bound of the one-sided 90% exact confidence interval will be less than 50% and we will consider the process feasible. If 5 or more of the first 15 patients have insufficient or delayed vaccine, we will consider the vaccine not feasible. The planned vaccination regimen will be administered even if the feasibility endpoints are not met.
Outcome measures
| Measure |
Personalized NeoAntigen Cancer Vaccine
n=11 Participants
\- NeoVax (peptides + poly-ICLC)
Poly-ICLC: 4 x 0.5 mg (total dose 2 mg) given on days Days 1, 4, 8, 15, 22, 78, and 134
Peptides: 4 x 300 mcg per peptide given on days Days 1, 4, 8, 15, 22, 78, and 134
|
|---|---|
|
Proportion of Participants for Whom Sequencing and Analysis Leads to Identification of at Least 10 Actionable Peptides to Initiate Vaccine Production
|
0.73 Proportion of participants
Interval 0.44 to 0.92
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Participants receiving NeoVax.
The induction of IFN-γ T-cell response will be based on ELISPOT assessments taken prior to vaccine administration and at week 16. The proportion of participants who achieve more than 55 SFU/10\*\*6 PBMC or 3 times their baseline level will be presented with a 90% exact binomial confidence interval. Based on a cohort of size 15, the confidence interval will be no wider than 0.46.
Outcome measures
| Measure |
Personalized NeoAntigen Cancer Vaccine
n=8 Participants
\- NeoVax (peptides + poly-ICLC)
Poly-ICLC: 4 x 0.5 mg (total dose 2 mg) given on days Days 1, 4, 8, 15, 22, 78, and 134
Peptides: 4 x 300 mcg per peptide given on days Days 1, 4, 8, 15, 22, 78, and 134
|
|---|---|
|
Proportion of Participants With Specific Cellular Immune Responses Following Administration of NeoVax
|
1.00 Proportion of participants
Interval 0.69 to 1.0
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Participants who received NeoVax.
The proportion of participants alive, without disease progression at two years after resection estimated using the method of Kaplan-Meier. The endpoint is calculated as the time between pathological confirmation of complete resection and the first of disease recurrence or death. The follow-up of participants disease-free at the time of study reporting is censored at the time of the last study visit. Participants disease-free at the time of their last assessment and who have either been lost to follow-up or withdrawn consent will have their follow-up censored at the time of the last study assessment.
Outcome measures
| Measure |
Personalized NeoAntigen Cancer Vaccine
n=8 Participants
\- NeoVax (peptides + poly-ICLC)
Poly-ICLC: 4 x 0.5 mg (total dose 2 mg) given on days Days 1, 4, 8, 15, 22, 78, and 134
Peptides: 4 x 300 mcg per peptide given on days Days 1, 4, 8, 15, 22, 78, and 134
|
|---|---|
|
Proportion of Participants Alive Without Progression at Two Years After Surgery Following Administration of NeoVax
|
0.75 proportion of participants
Interval 0.4 to 0.91
|
Adverse Events
Personalized NeoAntigen Cancer Vaccine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Personalized NeoAntigen Cancer Vaccine
n=8 participants at risk
\- NeoVax (peptides + poly-ICLC)
Poly-ICLC: 4 x 0.5 mg (total dose 2 mg) given on days Days 1, 4, 8, 15, 22, 78, and 134
Peptides: 4 x 300 mcg per peptide given on days Days 1, 4, 8, 15, 22, 78, and 134
|
|---|---|
|
General disorders
Fatigue
|
62.5%
5/8 • Number of events 5 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
General disorders
Fever
|
37.5%
3/8 • Number of events 3 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
General disorders
Flu like symptoms
|
50.0%
4/8 • Number of events 10 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
General disorders
Injection site reaction
|
100.0%
8/8 • Number of events 18 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
General disorders
Pain
|
25.0%
2/8 • Number of events 2 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Immune system disorders
Allergic reaction
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Bruising
|
37.5%
3/8 • Number of events 4 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • Number of events 4 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
3/8 • Number of events 5 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Investigations
Neutrophil count decreased
|
37.5%
3/8 • Number of events 3 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Investigations
White blood cell decreased
|
12.5%
1/8 • Number of events 3 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 2 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 2 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
37.5%
3/8 • Number of events 4 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
2/8 • Number of events 4 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.5%
3/8 • Number of events 4 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8 • Number of events 3 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Cardiac disorders
Sinus bradycardia
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Eye disorders
Blurred vision
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Eye disorders
Watering eyes
|
12.5%
1/8 • Number of events 2 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • Number of events 2 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Knee Gout
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Nervous system disorders
Headache
|
62.5%
5/8 • Number of events 6 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Renal and urinary disorders
Chronic kidney disease
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Reproductive system and breast disorders
Breast pain
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8 • Number of events 2 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
37.5%
3/8 • Number of events 6 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Wart-Like Lesion
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Vascular disorders
Hot flashes
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • Total of 2 years after treatment initiation.
Adverse events assessments every 3 months at re-staging follow-up visits (+/- 1 week) to continue until initiation of a new therapy for recurrent disease, withdrawal of consent, or death, whichever occurs first. All participants who receive one or more doses of NeoVax are included in the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place