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After interim analysis the study was halted to redesign a pivotal trial.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POL-103A without API | Placebo Comparator |
| |
| POL-103A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POL-103A | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 432 events or 8 years and 10 months |
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for WM range 1. |
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Overall survival (OS) was measured from randomization until death from any cause, assessed up to 76 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Slingluff, M.D. | University of Virginia Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer and Research Centers | Chandler | Arizona | 85224 | United States | ||
| University of Arizona Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34599031 | Derived | Slingluff CL, Lewis KD, Andtbacka R, Hyngstrom J, Milhem M, Markovic SN, Bowles T, Hamid O, Hernandez-Aya L, Claveau J, Jang S, Philips P, Holtan SG, Shaheen MF, Curti B, Schmidt W, Butler MO, Paramo J, Lutzky J, Padmanabhan A, Thomas S, Milton D, Pecora A, Sato T, Hsueh E, Badarinath S, Keech J, Kalmadi S, Kumar P, Weber R, Levine E, Berger A, Bar A, Beck JT, Travers JB, Mihalcioiu C, Gastman B, Beitsch P, Rapisuwon S, Glaspy J, McCarron EC, Gupta V, Behl D, Blumenstein B, Peterkin JJ. Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence. J Immunother Cancer. 2021 Oct;9(10):e003272. doi: 10.1136/jitc-2021-003272. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A POL-103A 40 Micrograms/Dose | POL-103A: 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. |
| FG001 | Part A POL-103A 100 Micrograms/Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2016 | Nov 27, 2024 |
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| POL-103A without API | Biological | 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 |
|
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 3 |
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 4 |
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 5 |
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 6 |
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 7 |
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 8 |
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 9 |
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 10 |
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 11 |
| 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. | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 12 |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | United States |
| City of Hope National Medical Center | Duarte | California | 91010 | United States |
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | United States |
| UCLA Hematology & Oncology Clinic | Los Angeles | California | 90095 | United States |
| Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | United States |
| Sutter Cancer Center | Sacramento | California | 95816 | United States |
| St. Mary's Hospital & Medical Center Department of Pathology | San Francisco | California | 94117 | United States |
| Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| The Melanoma Center at the Washington Cancer Institute | Washington D.C. | District of Columbia | 20010 | United States |
| GenesisCare USA of Florida | Jacksonville | Florida | 32204 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | United States |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| MD Anderson Cancer Center-Orlando | Orlando | Florida | 32806 | United States |
| Ameriderm Research | Ormond Beach | Florida | 32174 | United States |
| Advocate Medical Group | Niles | Illinois | 60714 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62794 | United States |
| Investigative Clinical Research of Indiana | Indianapolis | Indiana | 46260 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Central Kentucky Research Associates | Lexington | Kentucky | 40509 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Harry & Jeanette Weinberg Cancer Institute @ Franklin Square | Baltimore | Maryland | 21237 | United States |
| Ascension Providence Hospital | Southfield | Michigan | 48075 | United States |
| University of Minnesota Masonic Cancer Institute | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Cancer Center, Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| St. Louis University Hospital | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| John Theurer Cancer Center/ Hackensack Medical Center | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of NJ | New Brunswick | New Jersey | 08901 | United States |
| Mount Sinai School of Medicine | New York | New York | 10032 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Wake Forest University School of Medicine, Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Premier Health Partners Clinical Trials Research Alliance | Dayton | Ohio | 45431 | United States |
| Independence Family Health Center (Cleveland Clinic) | Independence | Ohio | 44131 | United States |
| Hillcrest Hospital (Cleveland Clinic) | Mayfield Heights | Ohio | 44124 | United States |
| Bend Memorial Clinic | Bend | Oregon | 97701 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Thomas Jefferson Medical Oncology | Philadelphia | Pennsylvania | 19107 | United States |
| McGlinn Cancer Institute, Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| The West Clinic P.C. d/b/a West Cancer Center | Germantown | Tennessee | 38138 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Cancer Solutions | Dallas | Texas | 75231 | United States |
| Baylor Research Institute | Dallas | Texas | 75246 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| The Huntsman Cancer Institute, University of Utah Health Care | Salt Lake City | Utah | 84112-5550 | United States |
| University of Virginia Hospital | Charlottesville | Virginia | 22908 | United States |
| Inova Schar Cancer Center | Fairfax | Virginia | 22031 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Multicare Institute for Research & Innovation | Tacoma | Washington | 98405 | United States |
| BCCA Vancouver Island Cancer Centre | Victoria | British Columbia | V8R6V5 | Canada |
| Durham Regional Cancer Centre | Oshawa | Ontario | L1G2B9 | Canada |
| Princess Margaret Hospital, Department of Medical Oncology | Toronto | Ontario | M5G 2M9 | Canada |
| CISSS de la Montérégie - Centre | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H4A3J1 | Canada |
| CHU de Quebec-L'Hotel-Dieu de Quebec | Québec | G1R2J6 | Canada |
POL-103A: 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. |
| FG002 | Part A 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. |
| FG003 | Part B1 POL-103A 40 Micrograms/Dose | 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. |
| FG004 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Overall Status of patients at the end of the study. This is applicable to Part B1 only. Study was halted prior to Part B2. | Posted | Count of Participants | Participants | 432 events or 8 years and 10 months |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for WM range 1. |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Part B1 participants randomized to seviprotimut-L 40 μg or placebo. Part B2 was not initiated. | Posted | Count of Participants | Participants | Overall survival (OS) was measured from randomization until death from any cause, assessed up to 76 months. |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 5 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 6 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 7 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 8 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 9 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 10 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 11 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change in bands | Serum was collected for Western blot testing and analysis on Day 0 (baseline) and at Week 10 for MW range 12 |
|
Adverse Events were assessed from study treatment administration to 30 days following the last dose of study treatment-up to 24 months. All-Cause Mortality was assessed from treatment administration up to 8 years and 10 months.
TEAE: AE b/w treatment (Tx) and 30 days post last dose, 2) AE started prior to Tx but worsened after Tx, 3) AE with partial onset/stop dated after 1st Tx and partial onset date did not definitely place AE before start date of Tx, 4) AE with missing onset date. AEs graded according to NCI Common Terminology Criteria for AEs. Participant counted once in most severe category w/multiple TEAEs reported; and once in closest related category when multiple TEAEs reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A POL-103A 40 Micrograms/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. | 12 | 52 | 0 | 52 | 48 | 52 |
| EG001 | Part A POL-103A 100 Micrograms/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. | 12 | 52 | 0 | 52 | 51 | 52 |
| EG002 | 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. | 6 | 53 | 0 | 53 | 51 | 53 |
| EG003 | 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. | 29 | 230 | 0 | 230 | 212 | 230 |
| EG004 | 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. | 20 | 117 | 0 | 117 | 113 | 117 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Injection site pruritus | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Injection site pain | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| Nausea | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Injection site urticaria | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| Dysplastic Naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Insomia | Psychiatric disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Actinic Keratosis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Director | Polynoma | 5418405451 | karihatten@polynoma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2019 | Nov 27, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Participants censored |
|
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. |
| OG002 | 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. |
|
|
|
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|