Bone Loss in Melanoma Survivors Receiving Immunotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-10

Study Completion Date

2025-06-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Dual X-ray Absorptiometry

Intervention Type PROCEDURE

Undergo DXA scan

Interventions

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Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Dual X-ray Absorptiometry

Undergo DXA scan

Intervention Type PROCEDURE

Other Intervention Names

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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

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No