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  • NCT03656718

Active, Not Recruiting

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) - CA209-8KX

Oppdatert: 6 desember, 2023   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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  • Phase 1/Phase 2

    Fase

  • Kjønn

  • 18+

    Aldersgruppe

  • Active, Not Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Part B, Group 2: nivolumab (dose 1)
Experimental: Part B, Group 4: nivolumab (dose 2)
Experimental: Part C: nivolumab (dose 3) + rHuPH20
Drug: rHuPH20 Biological: Nivolumab
Experimental: Part D: nivolumab (dose 3)
Experimental: Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20
Experimental: SC nivolumab
Experimental: SC nivolumab with rHuPH20

Nøkkelkriterier for kvalifikasjon

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types: 1. Metastatic squamous or non-squamous NSCLC 2. RCC, advanced or metastatic 3. Melanoma 4. HCC 5. CRC, metastatic (MSI-H or dMMR) - Measurable disease as per RECIST version 1.1 criteria - ECOG performance status of 0 or 1 Exclusion Criteria: - Active brain metastases or leptomeningeal metastases - Ocular melanoma - Active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria could apply

Vi anbefaler at du kontakter BMS for å rapportere bivirkninger.
Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046