Adjuvant/Neoadjuvant Immunotherapy in Melanoma Based on Serial Plasma ctDNA Monitoring
NCT07930182, Phase 2, Recruiting, H. Lee Moffitt Cancer Center and Research Institute
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Adjuvant/Neoadjuvant Immunotherapy in Melanoma Based on Serial Plasma ctDNA Monitoring | ClinicalTrials.gov |
| NCT number | NCT07930182 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 56 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute | ClinicalTrials.gov |
| Conditions | Melanoma | ClinicalTrials.gov |
| Interventions | Nivolumab, Ipilimumab, Haystack MRD ctDNA Assay | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Event-Free Survival (EFS) in the Neoadjuvant Cohort | Up to 5 Years | Defined as the time from initiation of study treatment to disease progression precluding surgery, melanoma recurrence, progression, or death from any cause. | ClinicalTrials.gov |
| Primary | Relapse-Free Survival (RFS) in the Adjuvant Cohort | Up to 5 years | Defined as the time from initiation of adjuvant treatment to melanoma recurrence or death from any cause. | ClinicalTrials.gov |
| Secondary | Pathologic Response Rate (Neoadjuvant Cohort) | Up to 12 weeks | Proportion of participants achieving pathologic response in the surgical specimen following neoadjuvant treatment, including pathologic complete response (pCR) and major pathologic response (MPR). | ClinicalTrials.gov |
| Secondary | Objective Response Rate (ORR) by RECIST v1.1 (Neoadjuvant Cohort) | Up to 12 weeks | Proportion of participants achieving a complete response or partial response according to RECIST version 1.1 based on radiographic assessments performed during neoadjuvant treatment. | ClinicalTrials.gov |
| Secondary | Relapse With Undetectable ctDNA | Up to 5 years | Frequency of participants who maintain undetectable circulating tumor DNA (ctDNA) during serial monitoring and subsequently experience clinical and/or radiographic melanoma relapse. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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 |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)