NCT05436990 is a Phase 2 clinical trial of Pembrolizumab, Vactosertib in Acral Melanoma, sponsored by Yonsei University.

Who is sponsoring NCT05436990?

NCT05436990 is sponsored by Yonsei University.

What drugs are being tested in NCT05436990?

Interventions in NCT05436990: Pembrolizumab, Vactosertib.

What condition does NCT05436990 study?

NCT05436990 studies Acral Melanoma, Mucosal Melanoma.

Is NCT05436990 still recruiting?

NCT05436990 is currently terminated. Last updated 2 April 2025.

Last reviewed 2025-04-02 · How we verify

NCT05436990

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Last updated 2 April 2025

What this trial tests

Phase 2 trial testing Pembrolizumab, Vactosertib in Acral Melanoma in 14 participants. Terminated before completion.

Timeline

9 February 2023

Primary endpoint
10 March 2025

10 March 2025

Quick facts

Lead sponsor	Yonsei University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	9 February 2023
Primary completion	10 March 2025
Estimated completion	10 March 2025
Sites	1 location across South Korea

Drugs / interventions tested

Pembrolizumab, Vactosertib — full drug profile →

Conditions studied

Acral Melanoma — all drugs for Acral Melanoma →
Mucosal Melanoma — all drugs for Mucosal Melanoma →

Sponsor

Yonsei University

Who can join

19 and older, any sex, with Acral Melanoma or Mucosal Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Acral Melanoma

Currently open trials in the same condition.

NCT06965231 — Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial · Phase 2 · recruiting
NCT05789043 — Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma · Phase 3 · recruiting
NCT05512481 — Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma · Phase 2 · recruiting
NCT05086692 — A Beta-only IL-2 ImmunoTherapY Study · Phase 1, PHASE2 · recruiting

Other Yonsei University trials

Trials by the same sponsor.

NCT07547592 — Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Soft Tissue Sarcoma · Phase 2 · not yet recruiting
NCT07524101 — Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD · NA · not yet recruiting
NCT07506629 — Adductor Canal Block Methods in Bilateral Total Knee Arthroplasty · NA · not yet recruiting
NCT07515716 — Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia · NA · not yet recruiting
NCT07507188 — Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05436990 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yonsei University
Last refreshed: 2 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05436990.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing