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This trial has completed recruitment on this platform, and is no longer accepting new referrals.

Trial With BNT111 and a Checkpoint Inhibitor in Combination or as Single Agents in Patients With Anti-PD-1- PD-LI Refractory/Relapsed, Unresectable Stage III or IV Melanoma

Trial ID: NCT04526899
This phase II interventional study is being conducted to evaluate the safety, efficacy, and tolerability of BNT111 and a checkpoint inhibitor in adults with anti-PD-1-refractory/relapsed, unresectable Stage III or IV Melanoma.

Trial Details

This study is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of the investigational drug BNT111 with a checkpoint inhibitor in anti-PD-1-PD-LI refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and the checkpoint inhibitor will be delineated in single agent calibrator arms. Patients in single agent calibrator arms, who experience disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent.

Estimated Enrollment

180 Participants

Phase

II

Eligibility Criteria

Participants must:

  • Adult, age 18 years and older
  • Histologically confirmed unresectable Stage III or IV cutaneous melanoma and measurable disease by RECIST 1.1
  • Confirmed disease progression on or after an approved anti-PD-1 regiment for melanoma as defined by RECIST 1.1
    • Previous exposure to approved anti-PD-1 containing regiment for at least 12 consecutive weeks and
    • Current radiological progression, to be confirmed with two scans. One scan may be sufficient in some cases and
    • Inclusion to trial must be within 6 months of confirmation of disease progression on anti-PD-1/PD-L1 treatment
  • Received approved anti-PD1/anti-PDL1 therapy.
  • Able to tolerate additional anti-PD-1 therapy
  • Eastern Cooperative Oncology Group (ECOG PS ≤ 1
  • Serum lactate dehydrogenase (LDH) ≤ upper limit of normal (ULN)
  • Confirmed BRAF mutation status
  • Adequate bone marrow, hepatic, kidney, function
  • Classified as stable with adequate coagulation
  • Female patients of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception throughout the study and for at least 6 months after the last dose of the study drug. Female patients also must not donate eggs (ova, oocytes) throughout the study and for at least 6 months after the last dose of the study drug.
  • Male patients that are sexually active must agree to use highly effective methods of contraception throughout the study, for at least 6 months after the last dose of the study drug. Male patients must agree to not donate sperm throughout the study period and for at least 6 months after the last dose of the study drug.

Participants must not:

  • History of uveal, acral or mucosal melanoma
  • History of primary immunodeficiencies (e.g. DiGeorge syndrome, SCID, Wiskott Aldrich syndrome, ataxia telangiectasis, common variable immunodeficiency)
  • Uncontrolled type 1 diabetes mellitus or with uncontrolled adrenal insufficiency
  • Any uncontrolled infection with HIV, Hepatitis B, Hepatitis C
  • Female patients that are pregnant or lactating
  • Prescence of another primary malignancy that has non been in complete remission for at least 2 years
  • New or growing brain or spinal metastases.
  • Current or recent use of systemic immunosuppression
  • No preexisting/recent evidence of significant autoimmune disease
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Trial Sites

Sites are located in the cities/states identified with the red pin: