Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma

Part of paid clinical trials in Manchester, New Hampshire.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT03620019
Phase
PHASE2
Status
Completed

Conditions

  • Cutaneous Melanoma
  • Melanoma
  • Melanoma (Skin)
  • Melanoma Stage Iii
  • Melanoma Stage Iv

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Denosumab — DRUG
    A dose of 120 mg will be administered as a subcutaneous (s.c.) injection every 4 weeks in the upper arm, upper thigh, or abdomen. Another loading dose of 120 mg s.c. denosumab will be administered on day 8. On days when denosumab is administered on the same day as pembrolizumab, the s.c. injection should be given after the infusion of pembrolizumab is completed.
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered as standard of care following the institutional guidelines.The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over approximately 30 minutes (range: 25 - 40 minutes) every 3 weeks until disease progression or unacceptable toxicity.
  • Nivolumab — DRUG
    Nivolumab will be given every four weeks at a dose of 480 mg to be administered as an IV infusion per institutional guidelines.

Study Details

This is a multicenter open-label, single-arm, phase II study designed to investigate the pharmacodynamic and antitumor effects of denosumab alone and in combination with an anti-Programmed death-1 or Programmed death ligand 1 (PD1) agent (pembrolizumab or nivolumab) in patients with unresectable Programmed death-1 or Programmed death ligand 1 (PD-1/PD-L1) inhibitor-naïve regional and distant metastatic melanoma (The American Joint Committee on Cancer (AJCC) stage III/IV). The pharmacodynamic and antitumor effects will be investigated by performing translational research on peripheral blood and tumor tissue collected before and during denosumab alone and in combination with anti-PD-1 treatment.

Key Dates

Start date
Sep 10, 2018
Status verified
Aug 2024
Primary completion
Apr 15, 2023
Completion
Aug 15, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm: Denosumab+ PD-1 Inhibitor
    Subjects in this trial will be given denosumab every 4 weeks, starting on day 1 of study treatment. An additional loading dose of denosumab will be administered on day 8. Subjects who started Pembrolizumab (initiated 21 days after the first dose of denosumab is given) will continue to have it administered intravenously (IV) every 3 weeks. New subjects will receive Nivolumab administered intravenously (IV) every 4 weeks (initiated 21 days after the first dose of denosumab is given). Combination therapy will continue as long as subjects benefit from therapy for up to 1 year.

Primary Outcome Measure

The Antitumor Effect of Denosumab Alone as Represented by the Change in Recent Thymic Emigrant Cells in Peripheral Blood [ Time Frame: 3 weeks after start of denosumab ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterManchesterNew Hampshire03104-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-

Find similar trials in Manchester, NH

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Dartmouth-Hitchcock Medical Center· Manchester, NHUNC Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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