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A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

Trial Profile

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Apr 2023

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At a glance

  • Drugs Avelumab (Primary)
  • Indications Adenocarcinoma; Adrenocortical carcinoma; Advanced breast cancer; Carcinoma; Colorectal cancer; Gastric cancer; Head and neck cancer; Malignant melanoma; Mesothelioma; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Prostate cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms JAVELIN Solid Tumor
  • Sponsors EMD Serono; EMD Serono Research & Development Institute; Merck KGaA
  • Most Recent Events

    • 01 May 2023 Results assessing the effects of sequential checkpoint inhibitors after therapeutic vaccine on immune responses in patients with mCRPC in the JAVELIN solid tumor phase 1 trial expansion cohort, enriched for patients with a previous therapeutic prostate cancer-targeted vaccine, published in the Journal of Immunotherapy.
    • 17 Dec 2021 Results from pooled data from JAVELIN 62 Merkel 200, JAVELIN Solid Tumor, and JAVELIN Solid Tumor JPN assessing (PK)-tumor growth dynamics (TGD) analysis published in the Clinical Cancer Research
    • 01 Aug 2021 Data from this study was used t0 assess the effects of assessment-schedule matching (ASM) on the relative effectiveness on the PFS of avelumab versus approved comparator immunotherapies or chemotherapy after population matching in the second-line (2L) setting for metastatic urothelial carcinoma and were published in the Value in Health.
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