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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

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: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Dec 2019

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At a glance

  • Drugs Bempegaldesleukin (Primary) ; VB10-NEO (Primary) ; Checkpoint kinase inhibitors
  • 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 Vaccibody
  • Most Recent Events

    • 27 Nov 2019 Number of arms changed from 1 to 2, VB10.NEO in combination with bempegaldesleukin (NKTR-214) will be given to paitents with SCCHN.
    • 05 Nov 2019 Interim results presented in a Vaccibody Media Release.
    • 07 Oct 2019 According to a Vaccibody media release, data from this trial will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2019 which will be held from November 6-10, 2019 in National Harbor, Maryland.
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