Clinical Stage III Cutaneous Melanoma AJCC v8NCT04516122
Bone Loss in Melanoma Survivors Receiving Immunotherapy
An observational study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Clinical Stage IV Cutaneous Melanoma AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Melanoma AJCC v8
- What is being tested?
- Biospecimen Collection and Dual X-ray Absorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to 18 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage III/IV melanoma receiving immune checkpoint inhibitor therapy at MD Anderson Cancer Center.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Loss in Cancer Survivors Receiving Adjuvant Immune Checkpoint Inhibitor Therapy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- 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
- Being tested
- Biospecimen Collection, Dual X-ray Absorptiometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood samples
Dual X-ray AbsorptiometryProcedure or surgery
Also called BMD scan, bone mineral density scan, DEXA, DEXA Scan
Undergo DXA scan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Dual X-ray Absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone density
Evaluated using dual X-ray absorptiometry (DXA).
Measured: 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.
Measured: Baseline up to 6 months after treatment initiation
Secondary outcomes (1)
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.
Measured: Baseline to 1.5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start10 May 2021
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Why it stopped: \<75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage III Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Noha Abdelwahab Hassan, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516122
- Sponsor's protocol ID
- 2020-0353
- Other IDs
- NCI-2020-05358, 2020-0353
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2020
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Loss in Cancer Survivors Receiving Adjuvant Immune Checkpoint Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT04516122
- Acronym / sponsor ID
- 2020-0353
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: \<75% participation
- Enrolment
- 12 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (biospecimen collection, DXA scan) | – | Procedure: Biospecimen Collection, Procedure: Dual X-ray AbsorptiometryPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage III/IV melanoma receiving immune checkpoint inhibitor therapy at MD Anderson Cancer Center.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood samples | Procedure or surgery | Observational (biospecimen collection, DXA scan) |
| Dual X-ray AbsorptiometryAlso: BMD scan, bone mineral density scan, DEXA, DEXA ScanUndergo DXA scan | Procedure or surgery | Observational (biospecimen collection, DXA scan) |
Primary outcome
Changes in bone density
Time frame: Baseline up to 6 months after treatment initiation
Evaluated using dual X-ray absorptiometry (DXA).
Change in done turnover markers
Time frame: Baseline up to 6 months after treatment initiation
Evaluated in bone turnover markers (serum CTX and BSAP) in the study patients.
1 secondary outcome
Development of fractures
Time frame: Baseline to 1.5 years of follow-up
Results and safety
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha Abdelwahab Hassan principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Clinical Stage IV Cutaneous Melanoma AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bone density (time frame: Baseline up to 6 months after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.