Trial · NCT02129075
A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma
NCT02129075, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2021-11-16
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma. Trials, record NCT02129075. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02129075
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma
- NCT number
- NCT02129075
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Cutaneous Melanoma, Melanoma, Melanoma of Unknown Primary, Mucosal Melanoma, Ocular Melanoma, Stage IIB Cutaneous Melanoma AJCC v6 and v7, Stage IIC Cutaneous Melanoma AJCC v6 and v7, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7
- Interventions
- DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Recombinant Flt3 Ligand
- First posted
- 2014-05-02
- Last updated
- 2021-11-16
- Results first posted
- 2021-11-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immune T-cell Response to NY-ESO-1 | At 12 weeks after final vaccination | Response rates will be analyzed by tabulating the frequency of positive response for each assay by antigen and treatment arm at each time point for which an assessment is performed. Response rates will be presented with their corresponding 95% confidence interval estimates calculated using the score test method. Fisher's exact tests will be used to compare cohort 1 and cohort 2 at the peak time point, with a significant difference declared if the 1-sided P value is =\< 0.10. |
| Secondary | T Cell Responses to Other Ongoing and Nascent Antitumor Response Antigens Associated With Melanoma (e.g. PRAME, MAGE-A3, p53, and gp1000) as Well as Memory and Chronic Viral Responses (CMV, EBV) | Up to 12 weeks after final vaccination | Response rates will be analyzed by tabulating the frequency of positive response for each assay by antigen and treatment arm at each time point for which an assessment is performed. Response rates will be presented with their corresponding 95% confidence interval estimates calculated using the score test method. Fisher's exact tests will be used to compare cohort 1 and cohort 2 at the peak time point, with a significant difference declared if the 1-sided P value is =\< 0.10. |
| Secondary | Frequency and Phenotypic Character of PBMC Subsets Including DCs, Monocyte Populations, T Cells, and NK Cells - Highest Peak Fold Change Over Baseline (Log 2 Fold) | Up to 12 weeks after final vaccination | Graphical and tabular summaries of the assay data will be made. Linear mixed effects model and possibly weighted generalized estimating equation methods will be considered for a supportive analysis of the longitudinal data over time. |
| Secondary | Tumor Recurrence | Up to 600 days from first vaccine | Time to first recurrence from first vaccine among subjects who have experienced recurrence. (days) |
| Secondary | Overall Survival | Up to 1 year after patient's 12 week visit | Overall survival not assessed |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Immune T-cell Response to NY-ESO-1 | At 12 weeks after final vaccination | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | T Cell Responses to Other Ongoing and Nascent Antitumor Response Antigens Associated With Melanoma (e.g. PRAME, MAGE-A3, p53, and gp1000) as Well as Memory and Chronic Viral Responses (CMV, EBV) | Up to 12 weeks after final vaccination | T cell responses to MAGE-A3 and PRAME; positive at any timepoint | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency and Phenotypic Character of PBMC Subsets Including DCs, Monocyte Populations, T Cells, and NK Cells - Highest Peak Fold Change Over Baseline (Log 2 Fold) | Up to 12 weeks after final vaccination | Only a subset of patient specimens were needed to meet statistical power. 15 participants were analyzed in Arm I (CDX-301, CDX-1401, and poly-ICLC and 16 participants were analyzed in Arm II (CDX-1401 and poly-ICLC). One less patient in Arm 1 was analyzed due to sample quality. | log 2 fold change | MEAN |
| SECONDARY | Tumor Recurrence | Up to 600 days from first vaccine | Analysis is reported for the number of subjects with recurrence (N=12 Arm I) (N=9 Arm II) | days | MEAN |
| SECONDARY | Overall Survival | Up to 1 year after patient's 12 week visit | Data not collected |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Immune T-cell Response to NY-ESO-1 | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 15 | Participants | ||
| Immune T-cell Response to NY-ESO-1 | Arm II (CDX-1401 and Poly-ICLC) | 10 | Participants | ||
| T Cell Responses to Other Ongoing and Nascent Antitumor Response Antigens Associated With Melanoma (e.g. PRAME, MAGE-A3, p53, and gp1000) as Well as Memory and Chronic Viral Responses (CMV, EBV) | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 7 | Participants | ||
| T Cell Responses to Other Ongoing and Nascent Antitumor Response Antigens Associated With Melanoma (e.g. PRAME, MAGE-A3, p53, and gp1000) as Well as Memory and Chronic Viral Responses (CMV, EBV) | Arm II (CDX-1401 and Poly-ICLC) | 7 | Participants | ||
| Frequency and Phenotypic Character of PBMC Subsets Including DCs, Monocyte Populations, T Cells, and NK Cells - Highest Peak Fold Change Over Baseline (Log 2 Fold) | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | cDCs | 30.4 | Standard Deviation 16.98 | log 2 fold change |
| Frequency and Phenotypic Character of PBMC Subsets Including DCs, Monocyte Populations, T Cells, and NK Cells - Highest Peak Fold Change Over Baseline (Log 2 Fold) | Arm II (CDX-1401 and Poly-ICLC) | cDCs | 0.9 | Standard Deviation 0.26 | log 2 fold change |
| Frequency and Phenotypic Character of PBMC Subsets Including DCs, Monocyte Populations, T Cells, and NK Cells - Highest Peak Fold Change Over Baseline (Log 2 Fold) | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | Monocytes | 6.1 | Standard Deviation 2.11 | log 2 fold change |
| Frequency and Phenotypic Character of PBMC Subsets Including DCs, Monocyte Populations, T Cells, and NK Cells - Highest Peak Fold Change Over Baseline (Log 2 Fold) | Arm II (CDX-1401 and Poly-ICLC) | Monocytes | 1.0 | Standard Deviation 0.18 | log 2 fold change |
| Frequency and Phenotypic Character of PBMC Subsets Including DCs, Monocyte Populations, T Cells, and NK Cells - Highest Peak Fold Change Over Baseline (Log 2 Fold) | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | CD4 T cells | 1.2 | Standard Deviation 0.28 | log 2 fold change |
| Frequency and Phenotypic Character of PBMC Subsets Including DCs, Monocyte Populations, T Cells, and NK Cells - Highest Peak Fold Change Over Baseline (Log 2 Fold) | Arm II (CDX-1401 and Poly-ICLC) | CD4 T cells | 1.1 | Standard Deviation 0.27 | log 2 fold change |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 30 | |
| Overall Study | STARTED | Arm II (CDX-1401 and Poly-ICLC) | 30 | |
| Overall Study | COMPLETED | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 30 | |
| Overall Study | COMPLETED | Arm II (CDX-1401 and Poly-ICLC) | 30 | |
| Overall Study | NOT COMPLETED | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (CDX-1401 and Poly-ICLC) | 0 |
Source ClinicalTrials.gov
Adverse events52
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 | General disorders and administration site conditions | General disorders | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 30 | 30 | 509 |
| other | General disorders and administration site conditions | General disorders | Arm II (CDX-1401 and Poly-ICLC) | 30 | 30 | 322 |
| other | Nervous system disorders | Nervous system disorders | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 17 | 30 | 35 |
| other | Nervous system disorders | Nervous system disorders | Arm II (CDX-1401 and Poly-ICLC) | 19 | 30 | 49 |
| other | Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 20 | 30 | 56 |
| other | Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Arm II (CDX-1401 and Poly-ICLC) | 18 | 30 | 33 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 15 | 30 | 37 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Arm II (CDX-1401 and Poly-ICLC) | 17 | 30 | 44 |
| other | Investigations | Investigations | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 14 | 30 | 43 |
| other | Investigations | Investigations | Arm II (CDX-1401 and Poly-ICLC) | 14 | 30 | 49 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | ||
| Total, all-cause mortality | Arm II (CDX-1401 and Poly-ICLC) | ||
| Total, other adverse events | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 30 | 30 |
| Total, other adverse events | Arm II (CDX-1401 and Poly-ICLC) | 30 | 30 |
| Total, serious adverse events | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | 0 | 30 |
| Total, serious adverse events | Arm II (CDX-1401 and Poly-ICLC) | 4 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35121932 | DERIVED |
Source PubMed
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| U01CA154967 | Cancer Immunotherapy Trials Network Central Operations and Statistical Center | CHEEVER, MARTIN ALEXANDER | FRED HUTCHINSON CANCER RESEARCH CENTER | NATIONAL CANCER INSTITUTE | 2010 to 2017 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (CDX-301, CDX-1401, and Poly-ICLC) vs Arm II (CDX-1401 and Poly-ICLC): Immune T-cell Response to NY-ESO-1 | Trial comparisons |
Arm I (CDX-301, CDX-1401, and Poly-ICLC) vs Arm II (CDX-1401 and Poly-ICLC): T Cell Responses to Other Ongoing and Nascent Antitumor Response Antigens Associated With Melanoma (e.g. PRAME, MAGE-A3, p53, and gp1000) as Well as Memory and Chronic Viral Responses (CMV, EBV) | Trial comparisons |
| Arm I (CDX-301, CDX-1401, and Poly-ICLC) vs Arm II (CDX-1401 and Poly-ICLC): 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT02129075
GET https://conductscience.org/api/trials/v1/NCT02129075/events?page=2