Trial · NCT06999980
Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)
NCT06999980, Phase 2, Recruiting, Melanoma Institute Australia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation). Trials, record NCT06999980. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06999980
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)
- NCT number
- NCT06999980
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 494 participants, estimated
- Lead sponsor
- Melanoma Institute Australia
- Conditions
- Cutaneous Melanoma, Mucosal Melanoma
- Interventions
- Ipilimumab 3mg/kg and nivolumab 1mg/kg, Ipilimumab 1mg/kg Nivolumab 480mg and relatlimab 160mg, Nivolumab 480mg and relatlimab 160mg, Ipilimumab 1mg/kg and nivolumab 3mg/kg, Pembrolizumab 200 mg
- First posted
- 2025-05-31
- Last updated
- 2026-02-19
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT06999980
GET https://conductscience.org/api/trials/v1/NCT06999980/registered