Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients With a High Risk of Recurrence

ClinicalTrials.gov ID

NCT01546571

Acronym / sponsor ID

MAVIS / 103A-301

Conditions

Melanoma

Phase

Phase 3

Study type

Interventional

Recruitment status

TerminatedReason stopped: After interim analysis the study was halted to redesign a pivotal trial.

Enrolment

504 participants (actual)

Lead sponsor

Polynoma LLCIndustry (pharma, biotech, devices)

Study start

1 May 2012 (actual)

Primary completion

29 Apr 2021 (actual)

Study completion

30 Jun 2021 (actual)

First posted

7 Mar 2012 (estimated)

Results

Posted 24 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Triple blind (participant, care provider, investigator)

Number of arms

2

Who may qualify

Ages

18 to 80 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Part B1: Recurrence Free Survival (RFS)

   Time frame: 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.

2. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight MW) Range 1 [0,20)

   Time frame: 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.

3. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 2 [20,28)

   Time frame: 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.

4. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 3 [28,36)

   Time frame: 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.

5. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 4 [36,44)

   Time frame: 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.

6. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 5 [44,53)

   Time frame: 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.

7. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 6 [53,62)

   Time frame: 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.

8. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 7 [62,72)

   Time frame: 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.

9. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 8 [72,83)

   Time frame: 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.

10. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 9 [83,94)

    Time frame: 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.

11. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 10 [94,105)

    Time frame: 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.

12. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 11 [105,118)

    Time frame: 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.

13. Part A:To Evaluate the Biological Activity of Seviprotimut-L in Patients With Molecular Weight (MW) Range 12 [118,Inf)

    Time frame: 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 34599031Slingluff 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

65 sites in 2 countries: see every site and its status.