Status:
COMPLETED
4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy
Lead Sponsor:
4SC AG
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Phase Ib/II open-label, multi-center study with a priming cycle of 4SC-202 to evaluate the safety, tolerability and preliminary efficacy of combination treatment with 4SC-202 and Pembrolizumab. A dose...
Eligibility Criteria
Inclusion
- Main
- Patients with unresectable stage III or stage IV cutaneous melanoma, as per American Joint Committee on Cancer (AJCC) (Version 8) staging system (must have been histologically confirmed at least once during course of disease). Patients with metastatic tumor of unknown primary site and histology of melanoma are eligible.
- Patients must be primary refractory or non-responding to anti-PD-1 therapy (either as monotherapy or in combination with Ipilimumab)
- Measurable disease by computer tomography (CT) or Magnetic resonance imaging (MRI) per immune-related response evaluation criteria in solid tumors (irRECIST) 1.1 criteria, with longest diameter for non-nodal lesions ≥ 10 mm and ≥ 15 mm in short axis for nodal lesions
- At least one tumor site (either primary site or metastasis) must be accessible for sequential biopsies and patient must consent to the 2 mandatory biopsies. This requirement is not applicable for continuous dosing schedules and may be waived by the sponsor in other individual cases.
- Main
Exclusion
- Patients who achieved a CR or PR, during or after prior anti-PD-1 mono- or anti-CTLA-4/anti-PD-1 combination therapy
- Patients with symptomatic brain metastases/central nervous system (CNS) involvement
- Patients with inadequate organ function
- Therapy with agents known to prolong the QT interval and increase the risk for Torsades de Pointes
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03278665
Start Date
September 25 2017
End Date
February 2 2022
Last Update
February 4 2022
Active Locations (7)
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1
Universitätsklinikum Essen
Essen, Germany
2
Medizinische Hochschule Hannover
Hanover, Germany
3
Universitätsklinikum Heidelberg
Heidelberg, Germany
4
Klinikum der Universität München
München, Germany