A Phase 1/2 interventional study of 4SC-202 in combination with Pembrolizumab in Malignant Melanoma, sponsored by 4SC AG. Completed at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-04.
Sponsored by 4SC AG · Phase 1/2, Interventional, and Treatment
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.
Main Inclusion Criteria:
Main Exclusion Criteria:
Single arm study of 4SC-202 in combination with Pembrolizumab
Drug: 4SC-202 in combination with Pembrolizumab
4SC-202 in combination with Pembrolizumab
Incidence of Adverse Events [Safety and Tolerability]
Safety and tolerability of the combination of 4SC-202 and Pembrolizumab will be assessed from adverse events.
Time frame: Up to 114 weeks
Objective Response Rate (ORR)
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)
Time frame: Up to 102 weeks
Best Overall Response (BOR)
The Best Overall Response defined as the best among all confirmed overall responses (irCR is better than irPR is better than irSD)
Time frame: Up to 102 weeks
Disease Control Rate (DCR)
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
Time frame: Up to 102 weeks
Duration of Response (DOR)
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.
Time frame: Up to 102 weeks
Progression Free Survival (PFS)
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.
Time frame: Up to 102 weeks
Time to Progression (TTP)
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.
Time frame: Up to 102 weeks
Overall Survival (OS)
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
Time frame: Up to 102 weeks
Plan to share: No
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4SC AG