Clinical Trials Logo
  1. Home
  2. Mucosal Melanoma
  3. NCT05436990

Antitumor Activity of Vactosertib in Combination With Pembrolizumab in Acral and Mucosal Melanoma Patients Progressed From Prior Immune Check Point Inhibitor

Mucosal Melanoma Clinical Trial

Official title:
A Phase II Multicenter Study to Assess the Antitumor Activity of Vactosertib in Combination With Pembrolizumab in Acral and Mucosal Melanoma Patients Progressed From Prior Immune Check Point Inhibitor

Clinical Trial Summary

This trial is a multicenter, single arm study of efficacy of vactosertib in combination with pembrolizumab in advanced acral or mucosal melanoma patients progressed prior treatment including immunotherapy or targeted therapy and chemotherapy. This trial will be conducted though Korean Cancer Study Group (KCSG). The KCSG is responsible for the project management of the trial. Patient recruitment will take at 4 institutions. Participants will be treated for up to 35 cycles (approximately 2 years) after initiation of treatment with intravenous 200mg of pembrolizumab every 3 weeks in combination with vactosertib. Vactosertib will be given orally for 200mg, bid for 5 days (from Mon. to Fri.) per week. This study will use ORR based on RECIST 1.1 and modified RECIST 1.1 (immune related RECIST) criteria as the primary endpoint and the tumor assessment will be done every 6 weeks. Secondary endpoints are DCR, PFS, OS, and safeties. Exploratory biomarkers predictive biomarker candidates (e.g., level of PD-L1 tumor expression, EMT marker, PD-L1, TGF-β RII, and pSMAD2) in tumor tissue and ctDNA in blood will be investigated in both pre-treatment and post-treatment periods.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05436990
Study type Interventional
Source Yonsei University
Contact Minkyu Jung
Phone +82-2-2228-8128
Email minkjung@yuhs.ac
Status Not yet recruiting
Phase Phase 2
Start date July 2022
Completion date December 2025
View Details
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Withdrawn NCT05482074 - Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2 Phase 2
Completed 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
Not yet recruiting NCT06424626 - A Trial of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma Phase 1
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
Not yet recruiting NCT05545969 - Neoadjuvant Pembrolizumab and Lenvatinib for Mucosal Melanoma Phase 2
Recruiting NCT03986515 - Apatinib Plus SHR1210 in Advanced Mucosal Melanoma Phase 2