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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03656718
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Neoplasms by Site

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — BIOLOGICAL
    (Subcutaneous) Specified dose on specified days
  • rHuPH20 — DRUG
    Specified dose on specified days Permeation enhancer
  • nivolumab — BIOLOGICAL
    (IV) Specified Dose on Specified Days

Study Details

The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20. This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: * non-small cell lung cancer (NSCLC) * renal cell carcinoma (RCC) * unresectable or metastatic melanoma * hepatocellular carcinoma (HCC) * microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC) * in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician * In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

Key Dates

Start date
Oct 29, 2018
Status verified
Oct 2025
Primary completion
Sep 7, 2022
Completion
Sep 12, 2024

Study Design

Enrollment
139 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A, Group 1: nivolumab (dose 1) + rHuPH20
  • Experimental: Part B, Group 3: nivolumab (dose 2) + rHuPH20
  • Experimental: Part B, Group 2: nivolumab (dose 1)
  • Experimental: Part B, Group 4: nivolumab (dose 2)
  • Experimental: Part C: nivolumab (dose 3) + rHuPH20
  • Experimental: Part D, Group 5: nivolumab (dose 3) + rHuPH20
  • Experimental: Part E, Group 6: nivolumab (dose 4) coformulated with rHuPH20

Primary Outcome Measure

Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E [ Time Frame: From first dose until approximately 21 days post first dose. ]

Locations (10)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute.AtlantaGeorgia30322-
Local Institution - 0024RockvilleMaryland20850-
Local Institution - 0020DetroitMichigan48201-2014-
Local Institution - 0001CharlotteNorth Carolina28204-
Local Institution - 0012EugeneOregon97401-
Greenville Health SystemGreenvilleSouth Carolina29605-
Local Institution - 0010AustinTexas78705-
Local Institution - 0009BeaumontTexas77702-1449-
Local Institution - 0007DallasTexas75246-
Local Institution - 0011TylerTexas75702-

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Winship Cancer Institute.· Atlanta, GALocal Institution - 0024· Rockville, MDLocal Institution - 0020· Detroit, MILocal Institution - 0001· Charlotte, NCLocal Institution - 0012· Eugene, ORGreenville Health System· Greenville, SC

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