TerminatedNot Applicable

Bone Loss in Melanoma Survivors Receiving Immunotherapy

Stopped: \<75% participation

United States12 participantsStarted 2021-05-10

Plain-language summary

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.

Who can participate

Age range40 Years

SexALL

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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

What they're measuring

Changes in bone density

Timeframe: Baseline up to 6 months after treatment initiation

Change in done turnover markers

Timeframe: Baseline up to 6 months after treatment initiation

Trial details

NCT IDNCT04516122

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-18

View on ClinicalTrials.gov More Clinical Stage III Cutaneous Melanoma AJCC v8 trials