NCT03278665

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 expansion cohort at the Recommended Phase Two Dose (RPTD) will be added. Adult patients with advanced (unresectable or metastatic) cutaneous melanoma primary refractory or non-responding to anti-PD-1 therapy as most current systemic anti-cancer therapy and for whom no standard therapy is available, will be enrolled. The last administration of anti-PD-1 therapy must have been performed within 6 months prior to screening.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_1

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
Last Updated

February 4, 2022

Status Verified

February 1, 2022

Enrollment Period

4.4 years

First QC Date

September 5, 2017

Last Update Submit

February 3, 2022

Conditions

Malignant Melanoma

Keywords

Cutaneous melanoma

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events [Safety and Tolerability]

    Safety and tolerability of the combination of 4SC-202 and Pembrolizumab will be assessed from adverse events.

    Up to 114 weeks

Secondary Outcomes (7)

  • Objective Response Rate (ORR)

    Up to 102 weeks

  • Best Overall Response (BOR)

    Up to 102 weeks

  • Disease Control Rate (DCR)

    Up to 102 weeks

  • Duration of Response (DOR)

    Up to 102 weeks

  • Progression Free Survival (PFS)

    Up to 102 weeks

  • +2 more secondary outcomes

Study Arms (1)

4SC-202 + Pembrolizumab

EXPERIMENTAL

Single arm study of 4SC-202 in combination with Pembrolizumab

Drug: 4SC-202 in combination with Pembrolizumab

Interventions

4SC-202 in combination with PembrolizumabDRUG

4SC-202 in combination with Pembrolizumab

4SC-202 + Pembrolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Universitätsklinikum Essen

Essen, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Klinikum der Universität München

München, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

Istituto Nazionale Tumori Fondazione "G. Pascale"

Napoli, Italy

Location

MeSH Terms

Conditions

Melanoma

Interventions

domatinostatpembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dirk Schadendorf, MD

    Universitätsklinikum Essen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 12, 2017

Study Start

September 25, 2017

Primary Completion

February 2, 2022

Study Completion

February 2, 2022

Last Updated

February 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(6)IT(1)