Status:
TERMINATED
Bone Loss in Melanoma Survivors Receiving Immunotherapy
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Clinical Stage III Cutaneous Melanoma AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Eligibility:
All Genders
40+ years
Brief 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 (...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 18 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04516122
Start Date
May 10 2021
End Date
June 18 2025
Last Update
August 17 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030