Trial · NCT03929029
Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma
NCT03929029, Phase 1, Active not recruiting, Dana-Farber Cancer Institute; results first posted 2024-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma. Trials, record NCT03929029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03929029
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma
- NCT number
- NCT03929029
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 11 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Cutaneous Melanoma
- Interventions
- Nivolumab (480 mg infusion), NeoVax plus Montanide, Ipilimumab
- First posted
- 2019-04-26
- Last updated
- 2026-01-05
- Results first posted
- 2024-10-31
- Limitations and caveats
- Small sample size.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicity (DLT) | 7 weeks after first dose of NeoVax | DLT (Protocol Section 5.5) definition: 1. Grade 3 or 4 toxicity that is definitely, probably, or possibly related to administration of vaccine, excluding transient (≤ 72 hours) flu-like symptoms; grade 3 nausea, vomiting, diarrhea, or constipation that returns to grade 2 (or lower) within 48 hours; any grade 3 rash that resolves to grade 2 or lower within 14 days; any grade 3 endocrine abnormality that is corrected with hormonal therapy within 4 weeks. 2. Grade 3 or 4 abnormal laboratory value that is at least possibly related to the administration of vaccine lasting for more than 7 days and requires hospitalization or medical intervention. Excludes any grade 3 electrolyte abnormality that: lasts ≤ 72 hours, is not clinically complicated, and resolves spontaneously or responds to conventional medical intervention. 3. Any grade 3 or grade 4 toxicity that is considered, in the opinion of the Principal Investigator, to be dose-limiting. 4. Any death related to study treatment. |
| Secondary | Number of Patients With Objective Response | Up to 26 weeks after first administration of NeoVax | The number of patients who had a best response to therapy of complete or partial response, as assessed by RECIST (Response Evaluation Criteria in Solid Tumors, Version 1.1). Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease of the sum of the diameters of target lesions; Progressive disease (PD): At least 20% increase in the sum of the diameters of target lesions; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | Number of Patients With Disease Progression/Recurrence | Up to 2 years | Number of patients with unresectable disease who experience disease progression (PD), per RECIST 1.1, or who had resectable disease and who experience disease recurrence. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-Limiting Toxicity (DLT) | 7 weeks after first dose of NeoVax | Patients who received at least 2 NeoVax administrations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Objective Response | Up to 26 weeks after first administration of NeoVax | Patients who received at least two doses of NeoVax. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Disease Progression/Recurrence | Up to 2 years | Patients who received at least 2 NeoVax administrations. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-Limiting Toxicity (DLT) | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 0 | Participants | ||
| Number of Patients With Objective Response | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 3 | Participants | ||
| Number of Patients With Objective Response | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 1 | Participants | ||
| Number of Patients With Disease Progression/Recurrence | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 2 | Participants | ||
| Number of Patients With Disease Progression/Recurrence | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 1 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Nivolumab Lead-In (Weeks 1-12) | STARTED | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 6 | |
| Nivolumab Lead-In (Weeks 1-12) | STARTED | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 5 | |
| Nivolumab Lead-In (Weeks 1-12) | COMPLETED | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 6 | |
| Nivolumab Lead-In (Weeks 1-12) | COMPLETED | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 5 | |
| Nivolumab Lead-In (Weeks 1-12) | NOT COMPLETED | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 0 | |
| Nivolumab Lead-In (Weeks 1-12) | NOT COMPLETED | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 0 | |
| Nivo, NeoVax, Ipilimumab (Weeks 12-21) | STARTED | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 5 | |
| Nivo, NeoVax, Ipilimumab (Weeks 12-21) | STARTED | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 5 | |
| Nivo, NeoVax, Ipilimumab (Weeks 12-21) | COMPLETED | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 5 | |
| Nivo, NeoVax, Ipilimumab (Weeks 12-21) | COMPLETED | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 5 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events258
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 3 | 6 | 14 |
| other | Anemia | Blood and lymphatic system disorders | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 1 | 5 | 4 |
| other | Palpitations | Cardiac disorders | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 0 | 6 | 0 |
| other | Palpitations | Cardiac disorders | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 1 | 5 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 0 | 6 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 1 | 5 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 1 | 6 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 0 | 5 | 0 |
| other | Hyperthyroidism | Endocrine disorders | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 1 | 6 | 1 |
| other | Hyperthyroidism | Endocrine disorders | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 0 | 5 | 0 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 1 | 6 |
| Total, all-cause mortality | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 1 | 5 |
| Total, other adverse events | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 6 | 6 |
| Total, other adverse events | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 5 | 5 |
| Total, serious adverse events | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | 1 | 6 |
| Total, serious adverse events | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 1 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA229261 | Dissecting melanoma-specific clonal T cell populations in patients treated with neoadjuvant immune checkpoint inhibition and personal neoantigen peptide vaccines. | Ott, Patrick Alexander | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 2018 to 2026 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) vs Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site): Number of Patients With Disease Progression/Recurrence | Trial comparisons |
| Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) vs Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site): Number of Participants With Dose-Limiting Toxicity (DLT) | Trial comparisons |
| Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) vs Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site): Number of Patients With Objective Response | Trial comparisons |
| Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) vs Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site): deaths from any cause | Trial comparisons |
| Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) vs Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03929029
GET https://conductscience.org/api/trials/v1/NCT03929029/events?page=2