Trial · NCT06906822
PLUG-IN: Pembrolizumab Combined With Enfortumab Vedotin for Advanced Melanoma Patients
NCT06906822, Phase 2, Active not recruiting, Grupo Español Multidisciplinar de Melanoma
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PLUG-IN: Pembrolizumab Combined With Enfortumab Vedotin for Advanced Melanoma Patients. Trials, record NCT06906822. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06906822
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PLUG-IN: Pembrolizumab Combined With Enfortumab Vedotin for Advanced Melanoma Patients
- NCT number
- NCT06906822
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Grupo Español Multidisciplinar de Melanoma
- Conditions
- Melanoma
- Interventions
- enfortumab vedotin, pembrolizumab
- First posted
- 2025-04-02
- Last updated
- 2026-09-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) | Throughout the study period,period, from initiation of treatment up to 2 years | Objective Response Rate (ORR) as assessed by the investigator through Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). This will be considered as the percentage/proportion of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study. Estimates of the ORR along with the associated 95% exact binomial confidence intervals will be provided. The binomial probability that the observed melanoma ORR is \> 0.15 will be calculated. Best confirmed response will be summarized. Response of melanoma will be measured by CT or MRI and assessed according to RECIST 1.1 by the investigator. If there are no assessments, the response will be taken to be unconfirmed and a non-response. Changes in tumor size from baseline will be calculated and displayed graphically, where appropriate. |
| Secondary | Progression-free Survival (PFS) 6 months | Throughout the study period, from initiation of treatment up to 6 months | Progression-free Survival (PFS) defined as the time from the start of treatment to disease progression or death from any cause, whichever occurs first. The PFS will be estimated by the Kaplan-Meier method. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without event will be censored on the date of first dose of the subsequent anticancer treatment. PFS will be displayed graphically where appropriate. PFS will be assessed by the median / mean (95% CI) and for different timepoints: Proportion of patients without progression at the end of follow-up. Proportion of patients at 6-months, 12-months and as deemed opportune by the time of the analysis. Confidence intervals (CIs) for the 25th, 50th and 75th percentiles will be reported. The Cox proportional hazards model will be fitted to compute the hazard ratios on potential stratified groups if applicable. |
| Secondary | Progression-free Survival (PFS) 12 months | Throughout the study period, from initiation of treatment up to 12 months | Progression-free Survival (PFS) defined as the time from the start of treatment to disease progression or death from any cause, whichever occurs first. The PFS will be estimated by the Kaplan-Meier method. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without event will be censored on the date of first dose of the subsequent anticancer treatment. PFS will be displayed graphically where appropriate. PFS will be assessed by the median / mean (95% CI) and for different timepoints: Proportion of patients without progression at the end of follow-up. Proportion of patients at 6-months, 12-months and as deemed opportune by the time of the analysis. Confidence intervals (CIs) for the 25th, 50th and 75th percentiles will be reported. The Cox proportional hazards model will be fitted to compute the hazard ratios on potential stratified groups if applicable. |
| Secondary | Overall survival (OS) | Throughout the study period, from initiation of treatment up to 12 months | Overall survival (OS): defined as the time elapsed from the first dose of study treatment until death from any cause. Patients alive and free of events at the date of the analysis will be censored at their last known contact. OS will be summarized using the Kaplan-Meier method and displayed graphically where appropriate. Confidence intervals (CIs) for the 25th, 50th and 75th percentiles will be reported. The Cox proportional hazards model will be fitted to compute the hazard ratios on potential stratified groups if applicable. OS will be calculated as median / mean (95% CI) and OS rate for different timepoints deemed appropriate at the time of the analysis (i.e.1-year OS rate) will also be calculated. |
| Secondary | Overall survival (OS) | Throughout the study period, from initiation of treatment up to 24 months | Overall survival (OS): defined as the time elapsed from the first dose of study treatment until death from any cause. Patients alive and free of events at the date of the analysis will be censored at their last known contact. OS will be summarized using the Kaplan-Meier method and displayed graphically where appropriate. Confidence intervals (CIs) for the 25th, 50th and 75th percentiles will be reported. The Cox proportional hazards model will be fitted to compute the hazard ratios on potential stratified groups if applicable. OS will be calculated as median / mean (95% CI) and OS rate for different timepoints deemed appropriate at the time of the analysis (i.e.1-year OS rate) will also be calculated. |
| Secondary | Clinical Benefit Rate (CBR) | Throughout the study period, from initiation of treatment up to 24 months | Clinical Benefit Rate (CBR): Assessed locally by the investigator through imaging follow-up (CT scan/MRI) using RECIST 1.1. CBR will include the percentage/proportion of patients with CR, PR, or SD (maintained \> 4 months) as their overall best response throughout the study period. The CBR will be estimated by binomial proportion, dividing the number of patients with CR, PR or SD for at least 4 months for CBR by the total number of patients studied in the population. The corresponding exact 2-sided 95% CIs will be provided. Changes in tumor size from baseline will be calculated and displayed graphically, where appropriate. |
| Secondary | Duration of Response (DoR): | Throughout the study period, from initiation of treatment up to 12 months | Duration of Response (DoR): The DoR will be calculated for patients who achieve a CR or PR. Dates of progression and censoring for DoR will be determined as described for PFS. Kaplan-Meier methods will be used to estimate the distribution of DoR. Quartiles including the median will be estimated by KM method along with their 95% confidence intervals. |
| Secondary | Treatment-free Survival (TFS) | Throughout the study period, from initiation of treatment up to 24 months | Treatment-free Survival (TFS): defined as the time from the end of study treatment until the start of subsequent treatment, progression or death, whichever occurs first, will be determined as described for PFS. Kaplan-Meier methods will be used to estimate TFS. |
| Secondary | Treatment-free Interval (TFI) | Throughout the study period, from initiation of treatment up to 24 months | Treatment-free Interval (TFI): defined as the time from the end of study treatment until the start of subsequent treatment; will be determined as described for PFS. Kaplan-Meier methods will be used to estimate TFI. |
| Secondary | Adverse Events (AEs) Safety Objective | Throughout the study period, from the inclusion of the first patient up to 24 months | Number of Participants with Adverse Events (AEs) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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.
Grants0
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.
None in this release.
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/NCT06906822
GET https://conductscience.org/api/trials/v1/NCT06906822/registered