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An Open Labelled First Human Dose Phase 1/2a Study to Evaluate Safety, Feasibility, Efficacy of Multiple Dosing With Individualised VB10.NEO and Bempegaldesleukin (NKTR-214) Immunotherapy in Patients With Locally Advanced or Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC), Clear Renal Cell Carcinoma, Urothelial Cancer or Squamous Cell Carcinoma of Head and Neck, Who Did Not Reach Complete Responses With Current Standard of Care Immune Checkpoint Blockade

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Trial Profile

An Open Labelled First Human Dose Phase 1/2a Study to Evaluate Safety, Feasibility, Efficacy of Multiple Dosing With Individualised VB10.NEO and Bempegaldesleukin (NKTR-214) Immunotherapy in Patients With Locally Advanced or Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC), Clear Renal Cell Carcinoma, Urothelial Cancer or Squamous Cell Carcinoma of Head and Neck, Who Did Not Reach Complete Responses With Current Standard of Care Immune Checkpoint Blockade

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 24 Apr 2023

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At a glance

  • Drugs Bempegaldesleukin (Primary) ; VB10-NEO (Primary)
  • Indications Head and neck cancer; Malignant melanoma; Non-small cell lung cancer; Renal cell carcinoma; Squamous cell cancer; Urogenital cancer
  • Focus Adverse reactions; First in man
  • Acronyms DIRECT-01
  • Sponsors Nykode Therapeutics
  • Most Recent Events

    • 20 Apr 2023 Status changed from active, no longer recruiting to completed.
    • 19 Apr 2023 Interim results (n=41; data cutoff: May 2022) presented at the 114th Annual Meeting of the American Association for Cancer Research
    • 30 Mar 2023 The trial has been discontinued in Germany, according to European Clinical Trials Database record.
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