Clinical Trials Logo

Clinical Trial Summary

The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival


Clinical Trial Description

This is a phase 2, open label, single cohort, single centre, clinical trial of neoadjuvant immunotherapy with dual inhibition of PD-1 and LAG-3 immune checkpoint pathways. The hypothesis is that neoadjuvant therapy produces a higher pathological response rate (pCR) and a longer recurrence-free survival in a cohort of treatment-naïve patients with resectable stage I (≥10 mm) to stage III Merkel cell carcinoma compared to neoadjuvant nivolumab monotherapy in Checkmate 358 (n=123, NCT02488759, historical control). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06151236
Study type Interventional
Source Melanoma Institute Australia
Contact Monica Osorio
Phone + 61 2 9911 7296
Email monica.osorio@melanoma.org.au
Status Recruiting
Phase Phase 2
Start date March 11, 2024
Completion date April 2034

See also
  Status Clinical Trial Phase
Recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Active, not recruiting NCT02978625 - Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Not yet recruiting NCT04705389 - SerUM Markers in MERkel Cell Carcinoma Patients: a Longitudinal moniTorIng Study for optiMization of European Guidelines N/A
Recruiting NCT03212404 - Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers Phase 1
Recruiting NCT05429866 - Immunological Variables Associated to ICI Toxicity in Cancer Patients Phase 2
Completed NCT04393753 - Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 Phase 2
Completed NCT03545334 - Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study N/A
Recruiting NCT04260802 - A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers Phase 1/Phase 2
Recruiting NCT04291885 - Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma Phase 2
Terminated NCT02054884 - F16IL2 Plus Paclitaxel in Metastatic Merkel Cell Carcinoma Phase 2
Recruiting NCT04975152 - Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma Phase 1
Not yet recruiting NCT06039033 - Exploring Merkel Cell Carcinoma Clinical Trial Engagement Patterns
Completed NCT02514824 - MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma Phase 1/Phase 2
Recruiting NCT06056895 - Triple Immune Checkpoint Inhibition for Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma Phase 2
Recruiting NCT03370861 - How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes
Suspended NCT04916002 - A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer Phase 2
Recruiting NCT03210935 - French National Database of Rare Dermatological Cancers
Active, not recruiting NCT04116320 - Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors Phase 1
Not yet recruiting NCT06086288 - Study of PembrolizumAb combiNeD With Cisplatin or carbOplatin and Etoposide in Treatment naïve Advanced meRkel Cell cArcinoma (MCC) Phase 2