Trial · NCT06999980
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological response rate | Week 6 | The primary endpoint is the pathological response rate at surgery (between days 43 and 56) from the first dose of neoadjuvant study treatment for each of cohorts 1b, 2 and 3. The pathological response is categorised thus: - Complete pathological response (pCR) - 0% viable tumour cells in the surgical specimen - Near complete pathological response - (near pCR) - \<10% viable tumour - Partial pathological response (pPR) - 10%-50% viable tumour - No pathological response (pNR) - \>50% viable tumour The proportion of participants with a pCR, or near pCR will determine the pathological response rate. |
| Secondary | Event-free survival (EFS) | 10 years | The proportion of patients with the earliest EFS outcome of: (a) Melanoma progression from randomisation and prior to planned surgery (b) Disease recurrence, from the date of surgery (local, regional or distant). (c) Study treatment-related death from randomisation. (d) Melanoma-related death, from randomisation. |
| Secondary | Objective response rate | Week 6 | RECIST version 1.1 defined objective response at week 6 for patients with RECIST-measurable disease at baseline |
| Secondary | Metabolic response rate | Week 6 | PERCIST defined metabolic response |
| Secondary | Loco-regional relapse-free survival | 10 years | Time from surgery to the date of loco-regional recurrence |
| Secondary | Distant metastases-free survival | 10 years | Time from surgery to the earliest date of distant recurrence, treatment-related death, or melanoma-related death |
| Secondary | Overall survival | at 1, 2, 5 and 10 years | Time from randomisation to death |
| Secondary | Type, frequency and severity of drug-related toxicities | 30 days from last dose of study treatment | The number, type, and grade of treatment-related adverse events per CTCAE version 5.0 |
| Secondary | Surgical adverse outcomes | At 3, 12 and 48 weeks post-operatively | The number and grade of surgical complications according to the Clavien-Dindo Classification assessed at 3, 12 and 48 weeks post-operatively |
| Secondary | Health related quality of life | 1 year | The individual, summary and composite scores obtained from the validated EUROQOL QLQ-C30, EQ-5D, FACT-M (questions M10 to M17) |
| Secondary | Comparison of the actual pathologocal response to each immunotherapy arm with the predicted pathological response to neoadjuvant immunotherapy based on the multi-omic predictive biomarker model | Week 6 | Correlation of the actual pathological response with the predicted response to combination neoadjuvant immunotherapy based on the multi-omic predictive biomarker model |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT06999980/registered