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4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy (SENSITIZE)

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ClinicalTrials.gov Identifier: NCT03278665
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
4SC AG

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.


Condition or disease Intervention/treatment Phase
Malignant Melanoma Drug: 4SC-202 in combination with Pembrolizumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase Ib/II, Multi-center Study of 4SC-202 in Combination With Pembrolizumab in Patients With Unresectable Stage III/Metastatic Stage IV Cutaneous Melanoma Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: 4SC-202 + Pembrolizumab
Single arm study of 4SC-202 in combination with Pembrolizumab
Drug: 4SC-202 in combination with Pembrolizumab
4SC-202 in combination with Pembrolizumab




Primary Outcome Measures :
  1. Incidence of Adverse Events [Safety and Tolerability] [ Time Frame: Up to 114 weeks ]
    Safety and tolerability of the combination of 4SC-202 and Pembrolizumab will be assessed from adverse events.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 102 weeks ]
    The Objective Response Rate (ORR) will be defined as the percentage of patients who have achieved a confirmed response of at least Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR)

  2. Best Overall Response (BOR) [ Time Frame: Up to 102 weeks ]
    The Best Overall Response defined as the best among all confirmed overall responses (irCR is better than irPR is better than irSD)

  3. Disease Control Rate (DCR) [ Time Frame: Up to 102 weeks ]
    The Disease Control Rate (DCR) will be defined as the percentage of patients who have achieved a confirmed response of at least irCR or irPR or a response of irSD

  4. Duration of Response (DOR) [ Time Frame: Up to 102 weeks ]
    Duration of response (DOR) is defined as the time from the first documentation of response to the date of disease progression. Patients who have no documented disease progression at the end of the study or who are lost to follow-up or who receive additional anti-neoplastic therapy after discontinuing 4SC-202 and Pembrolizumab will be censored at the date of their last extent of disease assessment or on the first date of additional therapy, respectively.

  5. Progression Free Survival (PFS) [ Time Frame: Up to 102 weeks ]
    The time from first dosing (C1D1) to date of first observed progression or death from any cause (whichever comes first). Patients who have not progressed while on study and have not died while on study will be censored at the last evaluable assessment date.

  6. Time to Progression (TTP) [ Time Frame: Up to 102 weeks ]
    The time from first dosing (C1D1) to first date of first observed progression. Patients who have not progressed while on study, have not died while on study or experienced a non-disease- related death will be censored at the last evaluable assessment date.

  7. Overall Survival (OS) [ Time Frame: Up to 102 weeks ]
    The Overall Survival (OS) is defined as the time from first dosing (C1D1) to date of death from any cause. Patients who have not died while on study will be censored at the last evaluable assessment date



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • 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 monotherapy as last systemic cancer directed treatment consisting of at least 2 cycles
  • 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.

Main Exclusion Criteria:

  • Patients who achieved, during or after prior anti-PD-1 therapy, a response of complete response (CR) or partial response (PR); or stable disease (SD) of a duration of more than 6 months (counted from the first dose of prior anti-PD-1 therapy to first date of documented progression)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278665


Contacts
Contact: Chief Medical Officer, MD +49 700 763 ext 0 medical.request@4sc.com

Locations
Germany
Universitätsklinikum Essen Recruiting
Essen, Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany
Klinikum der Universität München Recruiting
München, Germany
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany
Universitätsklinikum Würzburg Recruiting
Würzburg, Germany
Italy
Istituto Nazionale Tumori Fondazione "G. Pascale" Recruiting
Napoli, Italy
Sponsors and Collaborators
4SC AG
Investigators
Principal Investigator: Dirk Schadendorf, MD Universitätsklinikum Essen

Responsible Party: 4SC AG
ClinicalTrials.gov Identifier: NCT03278665     History of Changes
Other Study ID Numbers: 4SC-202-2-2017
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by 4SC AG:
Cutaneous melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Antineoplastic Agents