Trial · NCT07883759
Neoadjuvant Pembrolizumab in Patients With High Risk, Stage IIB/IIC Cutaneous Melanoma: a Single Arm Proof of Concept Phase IIA Study.
NCT07883759, Phase 2, Not yet recruiting, Centre Hospitalier Universitaire de Besancon
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Pembrolizumab in Patients With High Risk, Stage IIB/IIC Cutaneous Melanoma: a Single Arm Proof of Concept Phase IIA Study. Trials, record NCT07883759. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07883759
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Pembrolizumab in Patients With High Risk, Stage IIB/IIC Cutaneous Melanoma: a Single Arm Proof of Concept Phase IIA Study.
- NCT number
- NCT07883759
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 19 participants, estimated
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Conditions
- Stage IIB Melanoma, Stage IIC Melanoma
- Interventions
- Pembrolizumab neoadjuvant treatment, surgery, Adjuvant treatment
- First posted
- 2026-10-20
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Pathological Response (MPR) according to central review | up to Week 8 | Major Pathological Response (MPR) on the primary tumour surgical specimen in accordance with International Neoadjuvant Melanoma Consortium criteria \[(Tetzlaff et al. 2018; Amaria et al. 2019) including complete response (absence of viable tumour cells) and near-complete response (\<10% tumoral viable cells)\] |
| Secondary | toxicities | 4 years | incidence and grade for Adverse events (AEs), drug related AEs, drug related AE leading to discontinuation during neoadjuvant treatment, surgery related AEs, surgery related AE leading to delayed or cancellation of adjuvant treatment, SAE and SUSAR, according to NCI-CTCAE V5.0 until the end of treatment visit. |
| Secondary | Major Pathological Response (MPR) according to investigator assessment | at surgery | Major Pathological Response (MPR) on the primary tumor surgical specimen in accordance with International Neoadjuvant Melanoma Consortium criteria \[(Tetzlaff et al. 2018) including complete response (absence of viable tumor cells) and near-complete response (\<10% tumoral viable cells)\] |
| Secondary | Rate of micrometastatic sentinel lymph node (SLN) involvement | at surgery | Proportion of patients undergoing a sentinel lymph node (SLN) biopsy who have a positive result in the SLN, the number of SLN identified and the number harvested, the proportion of patients with positive SLN who undergo complete lymph node dissection. |
| Secondary | Study feasibility | 4 years | The number of patients who complete in totality the neoadjuvant treatment, who undergo surgery and who start the adjuvant therapy divided by the number of patients who initiated the neoadjuvant treatment, The rate of patient included divided by the number of patients screened. |
| Secondary | Overall response rate (ORR) preoperatively | from enrollment to surgery | Clinical response will be systematically assessed using clinical examination with standardized photographs of the primary tumor as the primary tumor will not be measured by CT scan. Complete response is defined as the disappearance of the lesion. Partial response is defined as the decrease in size of the lesion. Progression is defined as an increase in size of the lesion (\>25% with at least 2 mm increase in size for lesion below 1cm). |
| Secondary | Event-free survival (EFS) | up to 4 years | Event-free survival (EFS) defined as the time from neoadjuvant treatment initiation to the first of the following events: death of all causes, melanoma progression prior planned surgery leading to stage 3 or 4 disease or leading to unresectable disease, toxicity during the neoadjuvant treatment that preclude the surgery, local or distant recurrence after surgery, whichever occurred first Patients with no defined events observed during the follow-up will be censored at the date of last disease evaluation, which showed no evidence of relapse. |
| Secondary | Relapse-free survival (RFS) | up to 4 years | Relapse-free survival (RFS) after surgery defined as the time from surgery to relapse or death, whichever occurred first. Secondary melanoma cancers will not be regarded as RFS events, nonmelanoma cancers will be disregarded in the analysis. Data for patients lost to follow-up will be censored. |
| Secondary | Distant metastasis-free survival (DMFS) | up to 4 years | Distant metastasis-free survival (DMFS) as the time from surgery to relapse with distant metastasis or death, whichever occurred first. Data for patients lost to follow-up will be censored. |
| Secondary | Overall survival (OS) | up to 4 years | Overall Survival (OS): defined as the time from the neoadjuvant treatment initiation to death from any cause. Alive patient will be censored at last date known to be alive either during study treatment period or during follow-up period |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 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/NCT07883759
GET https://conductscience.org/api/trials/v1/NCT07883759/registered