Melanoma
Conditions
Brief summary
The purpose of this study is to determine how safe and how well POL-103A works in preventing the relapse of melanoma after patients who have undergone surgery.
Interventions
BIOLOGICALPOL-103A
POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
BIOLOGICALPOL-103A without API
Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
Sponsors
Polynoma LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed Stage IIb, IIc, III melanoma * Surgical resection within 90 days of first dosing * Persons with positive sentinel nodes must have a complete lymphadenectomy * ECOG performance status 0 or 1
Exclusion criteria
* Any prior melanoma treatment other than surgery or regional irradiation * Use of biologic response modifiers within 60 days of first dosing * Subjects with history of other malignancy within past 5 years (with exceptions)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 12 [118,Inf) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 12 | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
| Part B1: Recurrence Free Survival (RFS) | 432 events or 8 years and 10 months | This is an event driven trial. Recurrence-free survival time (RFS) is computed from the earliest of the date of recurrence or death or, if without recurrence or death, the date last assessed for recurrence without diagnosis of recurrence (censored). The date of recurrence is specified as the first date a recurrence is suspected, which is later confirmed by biopsy. |
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight MW) Range 1 [0,20) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for WM range 1. | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 2 [20,28) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 2 | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 3 [28,36) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 3 | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 4 [36,44) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 4 | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 5 [44,53) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 5 | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 6 [53,62) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 6 | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 7 [62,72) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 7 | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 8 [72,83) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 8 | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 9 [83,94) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 9 | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 10 [94,105) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 10 | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
| Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 11 [105,118) | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 11 | For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B1: Overall Survival (OS) | Overall survival (OS) was measured from randomization until death from any cause, assessed up to 76 months. | Overall survival (OS) analyses were based on the ITT analysis set; OS was defined as the duration from randomization until death. If the patient was alive, OS was censored at the earliest date the participant was known to be alive or the date of data cutoff. |
Countries
Canada, United States
Participant flow
Recruitment details
Part A (dose finding) was competitive enrollment from 6/1/2012 to 10/16/2013. Part B1 of the protocol was competitive enrollment from 1/1/2015 to 8/16/2016. The study was halted prior to Part B2. Types of sites range from clinical oncologist, dermatological and surgical oncologist.
Participants by arm
| Arm | Count |
|---|---|
| Part A POL-103A 40microgram/Dose POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years. | 52 |
| Part A POL-103A 100 Microgram/Dose POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years. | 52 |
| Part A POL-103A Without API POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years. | 53 |
| Part B1 POL-103A POL-103A: POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years. | 230 |
| Part B1 POL-103A Without API POL-103A without API: Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs. A total of 15 dosing visits over 2 years. | 117 |
| Total | 504 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 1 | 0 |
| Overall Study | assigned placebo in Part A | 0 | 0 | 22 | 0 | 0 |
| Overall Study | Death | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Disease Progression | 20 | 18 | 15 | 73 | 37 |
| Overall Study | Intercurrent Illness | 1 | 2 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 2 | 3 |
| Overall Study | Other | 0 | 0 | 3 | 0 | 0 |
| Overall Study | Other Cancers | 0 | 0 | 0 | 3 | 1 |
| Overall Study | Pregnancy | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 4 | 9 | 2 |
Baseline characteristics
| Characteristic | Part A POL-103A 40microgram/Dose | Part A POL-103A 100 Microgram/Dose | Part A POL-103A Without API | Part B1 POL-103A | Part B1 POL-103A Without API | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 9.74 | 53.8 years STANDARD_DEVIATION 12.73 | 55.8 years STANDARD_DEVIATION 14.9 | 56.3 years STANDARD_DEVIATION 12.73 | 55.8 years STANDARD_DEVIATION 13.73 | 56.1 years STANDARD_DEVIATION 13.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 1 Participants | 7 Participants | 4 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 50 Participants | 52 Participants | 222 Participants | 113 Participants | 487 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment North America | 52 participants | 52 participants | 53 participants | 230 participants | 117 participants | 504 participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 20 Participants | 96 Participants | 52 Participants | 202 Participants |
| Sex: Female, Male Male | 36 Participants | 34 Participants | 33 Participants | 134 Participants | 65 Participants | 302 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 12 / 52 | 12 / 52 | 6 / 53 | 29 / 230 | 20 / 117 |
| other Total, other adverse events | 48 / 52 | 51 / 52 | 51 / 53 | 212 / 230 | 113 / 117 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 | 0 / 53 | 0 / 230 | 0 / 117 |
Outcome results
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight MW) Range 1 [0,20)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for WM range 1.
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight MW) Range 1 [0,20) | 6.8 percentage of change in bands | Standard Deviation 44.9 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight MW) Range 1 [0,20) | 7.3 percentage of change in bands | Standard Deviation 26.1 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight MW) Range 1 [0,20) | -1.8 percentage of change in bands | Standard Deviation 29.8 |
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 10 [94,105)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 10
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 10 [94,105) | 13.7 percentage of change in bands | Standard Deviation 31.4 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 10 [94,105) | 4.0 percentage of change in bands | Standard Deviation 21.4 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 10 [94,105) | 9.9 percentage of change in bands | Standard Deviation 27.5 |
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 11 [105,118)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 11
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 11 [105,118) | 5.1 percentage of change in bands | Standard Deviation 23.8 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 11 [105,118) | 1.0 percentage of change in bands | Standard Deviation 19.3 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 11 [105,118) | 5.0 percentage of change in bands | Standard Deviation 31.7 |
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 12 [118,Inf)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 12
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 12 [118,Inf) | 2.3 percentage of change in bands | Standard Deviation 15.9 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 12 [118,Inf) | -5.3 percentage of change in bands | Standard Deviation 20.1 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 12 [118,Inf) | -15.5 percentage of change in bands | Standard Deviation 26.9 |
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 2 [20,28)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 2
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 2 [20,28) | 0.4 percentage of change in bands | Standard Deviation 22.3 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 2 [20,28) | 12.0 percentage of change in bands | Standard Deviation 38.4 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 2 [20,28) | -6.2 percentage of change in bands | Standard Deviation 16.3 |
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 3 [28,36)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 3
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 3 [28,36) | 14.8 percentage of change in bands | Standard Deviation 74.2 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 3 [28,36) | 9.3 percentage of change in bands | Standard Deviation 32.9 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 3 [28,36) | 0.5 percentage of change in bands | Standard Deviation 35.1 |
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 4 [36,44)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 4
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 4 [36,44) | 5.3 percentage of change in bands | Standard Deviation 24.6 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 4 [36,44) | 7.6 percentage of change in bands | Standard Deviation 20.7 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 4 [36,44) | 8.5 percentage of change in bands | Standard Deviation 43.5 |
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 5 [44,53)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 5
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 5 [44,53) | 1.3 percentage of change in bands | Standard Deviation 23.1 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 5 [44,53) | 9.5 percentage of change in bands | Standard Deviation 43.3 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 5 [44,53) | 10.3 percentage of change in bands | Standard Deviation 33 |
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 6 [53,62)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 6
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 6 [53,62) | -12.7 percentage of change in bands | Standard Deviation 19.5 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 6 [53,62) | 18.8 percentage of change in bands | Standard Deviation 49 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 6 [53,62) | 14.4 percentage of change in bands | Standard Deviation 29.1 |
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 7 [62,72)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 7
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 7 [62,72) | 6.8 percentage of change in bands | Standard Deviation 24.4 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 7 [62,72) | 5.5 percentage of change in bands | Standard Deviation 22.7 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 7 [62,72) | 7.9 percentage of change in bands | Standard Deviation 28.4 |
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 8 [72,83)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 8
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 8 [72,83) | -0.0 percentage of change in bands | Standard Deviation 18.2 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 8 [72,83) | 0.4 percentage of change in bands | Standard Deviation 16.8 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 8 [72,83) | 10.5 percentage of change in bands | Standard Deviation 35.9 |
Primary
Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 9 [83,94)
For Part A, immunogenicity of the vaccine was based on anti-melanoma IgG/IgM antibody response at week 10 compared to week 0. A positive result by Western Blot was considered an immunogenic response to study treatment. The response for each participant was calculated based on the average percent change in intensity across these Bins. The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%. The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin. No participant had multiple bands in a single Bin.
Time frame: Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 9
Population: The definition of response in each participant was the average percent change: \> 0% (meaning any change), or \> 5, 10, 15, 20, and 25%.~The bands having data in each Bin is the unit of analysis in each Bin and in all cases corresponds to the number of participants having bands in that Bin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 9 [83,94) | -0.8 percentage of change in bands | Standard Deviation 24.3 |
| Part B1 POL-103A Without API-IIB/IIC | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 9 [83,94) | 16.8 percentage of change in bands | Standard Deviation 25.6 |
| Part B1 POL-103A-IIIA | Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 9 [83,94) | 5.9 percentage of change in bands | Standard Deviation 34.7 |
Primary
Part B1: Recurrence Free Survival (RFS)
This is an event driven trial. Recurrence-free survival time (RFS) is computed from the earliest of the date of recurrence or death or, if without recurrence or death, the date last assessed for recurrence without diagnosis of recurrence (censored). The date of recurrence is specified as the first date a recurrence is suspected, which is later confirmed by biopsy.
Time frame: 432 events or 8 years and 10 months
Population: Overall Status of patients at the end of the study. This is applicable to Part B1 only. Study was halted prior to Part B2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part B1: Recurrence Free Survival (RFS) | Participants with recurrence | 32 Participants |
| Part B1 POL-103A-Stage IIB/IIC | Part B1: Recurrence Free Survival (RFS) | Participants censored | 42 Participants |
| Part B1 POL-103A Without API-IIB/IIC | Part B1: Recurrence Free Survival (RFS) | Participants with recurrence | 20 Participants |
| Part B1 POL-103A Without API-IIB/IIC | Part B1: Recurrence Free Survival (RFS) | Participants censored | 17 Participants |
| Part B1 POL-103A-IIIA | Part B1: Recurrence Free Survival (RFS) | Participants with recurrence | 18 Participants |
| Part B1 POL-103A-IIIA | Part B1: Recurrence Free Survival (RFS) | Participants censored | 51 Participants |
| Part B1 POL-103A Without API-IIIA | Part B1: Recurrence Free Survival (RFS) | Participants with recurrence | 13 Participants |
| Part B1 POL-103A Without API-IIIA | Part B1: Recurrence Free Survival (RFS) | Participants censored | 21 Participants |
| Part B1 POL-103A -IIIB/IIIC | Part B1: Recurrence Free Survival (RFS) | Participants with recurrence | 51 Participants |
| Part B1 POL-103A -IIIB/IIIC | Part B1: Recurrence Free Survival (RFS) | Participants censored | 36 Participants |
| Part B1 POL-103A Without API-IIIB/IIIC | Part B1: Recurrence Free Survival (RFS) | Participants with recurrence | 23 Participants |
| Part B1 POL-103A Without API-IIIB/IIIC | Part B1: Recurrence Free Survival (RFS) | Participants censored | 23 Participants |
| Part B1 POL-103A All Randomized | Part B1: Recurrence Free Survival (RFS) | Participants censored | 129 Participants |
| Part B1 POL-103A All Randomized | Part B1: Recurrence Free Survival (RFS) | Participants with recurrence | 101 Participants |
| Part B1 POL-103A Without API-All Randomized | Part B1: Recurrence Free Survival (RFS) | Participants with recurrence | 56 Participants |
| Part B1 POL-103A Without API-All Randomized | Part B1: Recurrence Free Survival (RFS) | Participants censored | 61 Participants |
Secondary
Part B1: Overall Survival (OS)
Overall survival (OS) analyses were based on the ITT analysis set; OS was defined as the duration from randomization until death. If the patient was alive, OS was censored at the earliest date the participant was known to be alive or the date of data cutoff.
Time frame: Overall survival (OS) was measured from randomization until death from any cause, assessed up to 76 months.
Population: Part B1 participants randomized to seviprotimut-L 40 μg or placebo. Part B2 was not initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part B1 POL-103A-Stage IIB/IIC | Part B1: Overall Survival (OS) | 97 Participants |
| Part B1 POL-103A Without API-IIB/IIC | Part B1: Overall Survival (OS) | 201 Participants |