Bone Loss in Melanoma Survivors Receiving Immunotherapy

NCT04516122 | Terminated

• 2 other identifiers: 2020-0353NCI-2020-05358
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; 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

Outcome Measures

Primary Outcomes (2)

• Changes in bone density

  Evaluated using dual X-ray absorptiometry (DXA).

  Baseline up to 6 months after treatment initiation

• 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 Outcomes (1)

• Development of fractures

  Baseline to 1.5 years of follow-up

Study Arms (1)

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.

Procedure: Biospecimen Collection; Procedure: Dual X-ray Absorptiometry

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Observational (biospecimen collection, DXA scan)

Dual X-ray Absorptiometry PROCEDURE

Undergo DXA scan

Also known as: BMD scan, bone mineral density scan, DEXA, DEXA Scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN

Observational (biospecimen collection, DXA scan)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage III/IV melanoma receiving immune checkpoint inhibitor therapy at MD Anderson Cancer Center.

You may qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Noha Abdelwahab Hassan

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: May 10, 2021
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)