Bone Loss in Melanoma Survivors Receiving Immunotherapy

Overview

This study investigates the bone-related side effects caused by immunotherapy drugs such as nivolumab and pembrolizumab in patients with melanoma. Nivolumab and pembrolizumab are immunotherapy drugs (drugs that boost your immune system) used to prevent cancer from coming back in patients with melanoma. Specifically, researchers want to learn if there is any relationship between receiving immunotherapy and bone density (thickness) measured by a dual-energy X-ray absorptiometry (DXA) scan or bone turnover markers (which indicate levels of bone loss) found in the blood. This study may provide researchers with more information on bone loss and may help prevent bone loss in future patients.

Full Title of Study: “Bone Loss in Cancer Survivors Receiving Adjuvant Immune Checkpoint Inhibitor Therapy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 31, 2026

Detailed Description

PRIMARY OBJECTIVES: I. Characterize the effects of adjuvant immune checkpoint inhibitor (ICI) therapy (nivolumab or pembrolizumab) on measures of bone health, including bone density and bone turnover markers, in a prospectively recruited cohort of 40 adult patients (>= 40 years) with melanoma diagnoses seen at MD Anderson Cancer Center. II. Identify associations of baseline demographic, clinical, and general bone loss risk factors (e.g., age, corticosteroid use) and tumor characteristics with bone loss in the same cohort. OUTLINE: Patients undergo collection of blood samples after starting immunotherapy and then at 6 and 12 months. Patients also undergo DXA scan over 5-10 minutes after starting immunotherapy and at 12 months.

Interventions

  • Procedure: Biospecimen Collection
    • Undergo collection of blood samples
  • Procedure: Dual X-ray Absorptiometry
    • Undergo DXA scan

Arms, Groups and Cohorts

  • Observational (biospecimen collection, DXA scan)
    • Patients undergo collection of blood samples after starting immunotherapy and then at 6 and 12 months. Patients also undergo DXA scan over 5-10 minutes after starting immunotherapy and at 12 months.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in bone density
    • Time Frame: Baseline up to 6 months after treatment initiation
    • Evaluated using dual X-ray absorptiometry (DXA).
  • Change in done turnover markers
    • Time Frame: Baseline up to 6 months after treatment initiation
    • Evaluated in bone turnover markers (serum CTX and BSAP) in the study patients.

Secondary Measures

  • Development of fractures
    • Time Frame: Baseline to 1.5 years of follow-up
    • Will be assessed by review of patient’s electronic medical records. Will evaluate the associations of each demographic, clinical, and general bone loss risk factor and tumor characteristic with change in bone density using linear regression models in univariate and multivariate settings. We will also summarize bone fractures descriptively according to the proportion of patients experiencing fractures and the time from treatment initiation to fracture.

Participating in This Clinical Trial

Inclusion Criteria

  • Stage III or IV melanoma with no evidence of disease following resection according to the 2009 American Joint Committee on Cancer classification criteria – No prior history of osteoporosis or fractures as per medical record review and patient history – Scheduled to begin receiving adjuvant ICI therapy (nivolumab or pembrolizumab) irrespective of dose or setting – Plan to continue care, including ICI infusions, at MD Anderson

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Noha Abdelwahab Hassan, Principal Investigator, M.D. Anderson Cancer Center

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