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NCT04516122 Clinical Trial

Bone Loss in Melanoma Survivors Receiving Immunotherapy

Clinical Stage IV Cutaneous Melanoma AJCC v8 Clinical Trial

Official title:
Bone Loss in Cancer Survivors Receiving Adjuvant Immune Checkpoint Inhibitor Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04516122
Other study ID # 2020-0353
Secondary ID NCI-2020-0535820
Status Active, not recruiting
Phase
First received
Last updated
Start date May 10, 2021
Est. completion date July 31, 2026

Study information
Verified date February 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 12
Est. completion date July 31, 2026
Est. primary completion date July 31, 2026
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Melanoma
  • Pathologic Stage III Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIID Cutaneous Melanoma AJCC v8
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Skin Neoplasms

Intervention

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

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in bone density Evaluated using dual X-ray absorptiometry (DXA). Baseline up to 6 months after treatment initiation
Primary Change in done turnover markers Evaluated in bone turnover markers (serum CTX and BSAP) in the study patients. Baseline up to 6 months after treatment initiation
Secondary Development of fractures 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. Baseline to 1.5 years of follow-up
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