Clinical trial · Observational
Bone Loss in Melanoma Survivors Receiving Immunotherapy
Bone Loss in Cancer Survivors Receiving Adjuvant Immune Checkpoint Inhibitor Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): \<75% participation
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage III Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IV Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage III Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IIID Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IV Cutaneous Melanoma AJCC v8 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Dual X-ray Absorptiometry | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Dual X-ray Absorptiometry
Primary outcomes (2)
- measure
- Changes in bone density
- timeFrame
- Baseline up to 6 months after treatment initiation
- description
- Evaluated using dual X-ray absorptiometry (DXA).
- measure
- Change in done turnover markers
- timeFrame
- Baseline up to 6 months after treatment initiation
- description
- Evaluated in bone turnover markers (serum CTX and BSAP) in the study patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available