Bone density changes with anti-PD-1 immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot enrolls adults with non-metastatic cancers who are planning to start or are within four weeks of starting FDA-approved anti-PD-1 therapy. Participants undergo bone mineral density measurement by dual-energy X-ray absorptiometry (DXA) and microarchitectural imaging by high-resolution peripheral quantitative CT (HR-pQCT) to track changes over time. The protocol excludes patients with metastatic disease, known osteoporosis/osteopenia, recent bisphosphonate or denosumab use, planned dual checkpoint therapy, and certain endocrine or advanced renal disorders. The goal is to characterize changes in bone mass and structure during anti-PD-1 therapy to inform monitoring and preventive care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients planning to start or within the first four weeks of treatment with anti-PD-1 immune checkpoint inhibitor therapy either alone or in combination with chemotherapy for curative intent for a known cancer diagnosis (use of immunotherapy must be FDA-approved and not experimental).
3. Life expectancy of at least 12 months per the discretion of the treating physician.

Exclusion Criteria:

1. Patients ineligible for anti-PD-1 therapy.
2. Patients with metastatic disease.
3. Patients planning treatment with dual immune checkpoint inhibitor therapy.
4. Bony fractures in the pelvis, bilateral hips/femurs, thoracic spine, or lumbar spine.
5. Known osteoporosis or osteopenia.
6. Planned or previous treatment with denosumab, zoledronic acid, or other bisphosphonate therapy in the last six months.
7. Parathyroid gland disorders, rheumatoid arthritis (unless well-controlled off active biologic therapy without chronic steroid use), CKD stage IV/V, or ESRD.
8. Inability to comply with study procedures.
9. Inability to lie flat for 20-25 minutes during an imaging session.
10. Pregnant or breastfeeding patients.
11. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.

Where it's running

• Vanderbilt-Ingram Cancer Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Jessica Sharpe, MD, PhD
• Email: jessica.m.sharpe@vumc.org
• Phone: 615-936-8422

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bexmarilimab plus nivolumab in solid tumors, melanoma, and NSCLC

  This trial tests whether adding bexmarilimab to nivolumab can help people with melanoma, non-small cell lung cancer, or other advanced solid tumors whose cancer stopped responding to immune therapy.

  Recruiting at 2 sites Phase 1/2 Institute of Cancer Research, United Kingdom · Manchester and 1 other locations · NCT07718243

• Galectin-3 levels and outcomes with PD-1/PD-L1 therapy in kidney, bladder, lung, and liver cancer

  This study tests whether blood galectin‑3 levels before treatment predict outcomes for people with kidney, bladder, lung, or liver cancer who are starting PD‑1/PD‑L1 immunotherapy.

  Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv, Israel · NCT07485114

• Predicting who responds to anti-PD-1/PD-L1 therapy using blood extracellular vesicle tests

  This study tests whether immune biomarkers found in blood extracellular vesicles can predict who with NSCLC or unresectable melanoma will respond to anti-PD-1/PD-L1 therapies.

  Recruiting at 2 sites Centre Georges Francois Leclerc · Besançon and 4 other locations · NCT07376512

• Analyzing solid tumors for HLA loss and collecting T cells for CAR T-cell therapy

  This study is testing how often solid tumors lose a key protein that helps the immune system recognize them, while also collecting T cells from patients with high-risk cancers to prepare for future CAR T-cell therapy.

  Recruiting at 13 sites A2 Biotherapeutics Inc. · Gilbert, Arizona and 15 other locations · NCT04981119

• Patient-specific MRD liquid biopsy for resected NSCLC

  This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.

  Recruiting Yonsei University · Yongin-si, Gyeonggi-do and 2 other locations · NCT07921888

• Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

  This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.

  Recruiting Phase 2 Cho Ray Hospital · Ho Chi Minh City · NCT07911449

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.