Bone Loss in Melanoma Survivors Receiving Immunotherapy

M.D. Anderson Cancer Center

Status: Terminated

Conditions: Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Pathologic Stage IIID Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Clinical Stage III Cutaneous Melanoma AJCC v8; Pathologic Stage IIIA Cutaneous Melanoma AJCC v8; Pathologic Stage III Cutaneous Melanoma AJCC v8

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04516122

2020-0353 (Other Identifier)

NCI-2020-05358 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

12 participants in 1 patient group

Observational (biospecimen collection, DXA scan)

Description:

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.

Treatment:

Procedure: Dual X-ray Absorptiometry

Procedure: Biospecimen Collection