Clinical Trials Logo

Clinical Trial Summary

In many cancers, early stage diagnosis and early treatment offers the best chance of a prolonged recurrence free- and overall survival. Neoadjuvant immunotherapy involves administering immune checkpoint inhibitors before surgical resection in high-risk resectable disease, such as mucosal melanoma. In resectable cancers, immune checkpoint inhibitors can enhance anti-tumour immunity by exploiting a competent immune system prior to surgery. Activating antigen-specific T cells found in the primary or baseline tumour continue to exert anti-tumour effects on remaining neoplastic cells after the resection of the original tumour, potentially preventing recurrences from occurring. In resectable mucosal melanoma, an opportunity exists to improve clinical outcomes with the addition of neoadjuvant and adjuvant systemic therapy with nivolumab and lenvatinib as an adjunct to surgery.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05545969
Study type Interventional
Source Melanoma Institute Australia
Contact Georgina Long, MBBS, PhD
Phone +612 9911 7200
Email ealong@melanoma.org.au
Status Not yet recruiting
Phase Phase 2
Start date March 2024
Completion date May 2036

See also
  Status Clinical Trial Phase
Completed NCT01961115 - Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma Phase 2
Active, not recruiting NCT03241186 - Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma Phase 2
Withdrawn NCT05482074 - Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2 Phase 2
Active, not recruiting NCT02858869 - Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases Phase 1
Completed NCT04551352 - A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas Phase 1
Active, not recruiting NCT03033576 - Testing Treatment With Ipilimumab and Nivolumab Compared to Treatment With Ipilimumab Alone in Advanced Melanoma Phase 2
Terminated NCT01166126 - Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV Phase 2
Completed NCT02158520 - Nab-Paclitaxel and Bevacizumab or Ipilimumab as First-Line Therapy in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery Phase 2
Withdrawn NCT03220009 - Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma Phase 2
Recruiting NCT05628883 - Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma Phase 1
Active, not recruiting NCT03178123 - The Study of JS001 Compared to High-Dose Interferon In Patients With Mucosal Melanoma That Has Been Removed by Surgery Phase 2
Recruiting NCT04462965 - Postoperative Adjuvant Treatment of Completely Resected Mucosal Melanoma Phase II Study Phase 2
Recruiting NCT04830124 - Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma - ARTISTRY-6 Phase 2
Completed NCT00085189 - Vaccine Therapy in Treating Patients With Stage IIC-IV Melanoma Phase 2
Recruiting NCT05384496 - Axitinib and Nivolumab for the Treatment of Mucosal Melanoma Phase 2
Recruiting NCT06319196 - Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma Phase 2
Completed NCT02126579 - Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists Phase 1/Phase 2
Recruiting NCT03986515 - Apatinib Plus SHR1210 in Advanced Mucosal Melanoma Phase 2
Completed NCT00110019 - Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery Phase 3
Recruiting NCT04472806 - Maintenance Treatment of Toripalimab(JS001) in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma Phase 2