Trial · NCT03425461
Anti-SEMA4D Monoclonal Antibody VX15/2503 With Nivolumab or Ipilimumab in Treating Patients With Stage III or IV Melanoma
NCT03425461, Phase 1, Terminated, Jonsson Comprehensive Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Anti-SEMA4D Monoclonal Antibody VX15/2503 With Nivolumab or Ipilimumab in Treating Patients With Stage III or IV Melanoma. Trials, record NCT03425461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03425461
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-SEMA4D Monoclonal Antibody VX15/2503 With Nivolumab or Ipilimumab in Treating Patients With Stage III or IV Melanoma
- NCT number
- NCT03425461
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Conditions
Metastatic Melanoma, 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
- Anti-SEMA4D Monoclonal Antibody VX15/2503, Ipilimumab, Laboratory Biomarker Analysis, Nivolumab, Pharmacological Study
- First posted
- 2018-02-07
- Last updated
- 2021-04-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose of anti-SEMA4D monoclonal antibody VX15/2503 determined by dose limiting toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 | Up to 21 days | Simple descriptive statistics will be used to summarize toxicities observed at each monitoring visit through the treatment and follow up period such as absolute neutrophil count), severity (by Toxicity Table) and nadir or maximum values for the laboratory measures, time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course. Baseline information (e.g. the extent of prior therapy) and demographic information will be presented, as well, to describe the patients treated in this pilot study. |
| Secondary | Antitumor activity assessed using tumor response | Up to 5 years | Potential objective responses classifications (complete response \[CR\], partial response \[PR\] and stable disease) to this combinatorial immunotherapy will be defined and recorded following Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, immune related response criterion (irRC) and immune related RECIST (irRECIST) criteria. |
| Secondary | Duration of response | From the time measurement criteria is met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented up to 5 years | |
| Secondary | Frequency of tumor measurements | Up to 5 years | |
| Secondary | Incidence of adverse events based on the Common Toxicity Criteria version 4.0 | Up to 2 years | Adverse events will be tabulated by type, severity, and the frequency and proportion of subjects experiencing the event. |
| Secondary | Response for in-transit metastasis | Up to 5 years | Response will be assessed, taking the measurement from pictures with a built-in ruler. |
| Other | T cell Infiltration | Baseline and 4 weeks after treatment starts | Will be analyzed using quantitative digital pathology. |
| Other | T cell receptor (TCR) clonality in tumors | Baseline and 4 weeks after treatment starts | Will analyze TCR clonality by deep sequencing the TCR Vbeta complementarity-determining region (CDR) region using the ImmunoSeq assay from Adaptive Biotech. |
| Other | Tumor immune microenvironment | Baseline and 4 weeks after treatment starts | Will be assessed using immunohistochemistry and analyzed using quantitative digital pathology. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA016042 | Cancer Center Support Grant | TEITELL, MICHAEL A | UNIVERSITY OF CALIFORNIA LOS ANGELES | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03425461
GET https://conductscience.org/api/trials/v1/NCT03425461/registered