Anti-PD-1 Immunotherapy for Cancer

Overseen By Jessica Sharpe, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jessica Mezzanotte Sharpe

Must be taking: Anti-PD-1 therapy

Must not be taking: Bisphosphonates, Denosumab

Disqualifiers: Metastatic disease, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by blocking protein interactions that normally prevent the immune system from recognizing and destroying cancer cells. However, these agents, now approved for over 15 types of cancers and for both early-stage and metastatic disease, are capable of causing inflammation in any organ system of the body that can lead to organ damage, dysfunction, and even death in rare cases. Some patients may suffer acute and treatable complications like joint pain, but some may have irreversible complications like hypothyroidism that requires daily, life-long medication. It is therefore important to fully understand the different types of damage ICIs can cause to better monitor patients receiving ICI therapy.

A rising concern from recent reports in the literature is that ICIs may weaken bone and increase the risk of fractures. In this study, the investigators aim to characterize how ICIs impact the bone by examining several factors in patients undergoing curative-intent ICI treatment either alone or in combination with chemotherapy: bone mineral density, bone volume, and markers of bone turnover in the blood. The study will use two imaging techniques to assess bone mineral density and volume. DXA (dual X-ray absorptiometry) imaging uses low-dose X-rays to measure how dense (or strong) bones are and is often used to diagnose or assess the risk of osteoporosis. High-resolution peripheral quantitative computed tomography (HRpQCT) is a 3D imaging technology that can quantify bone structure and volume and offers high resolution that can be used to assess bone in smaller bones of the peripheral skeleton.

The investigators hypothesize that ICI treatment will weaken bones and increase the risk of fractures. As ICI therapy is relatively new, a rising number of patients may be at risk of fractures or have low bone density that is not being monitored because there are no guidelines in place notifying physicians of this potential risk to patients. This is study will provide important preliminary data that will be the basis for larger studies in the future aiming to better monitor and potentially treat bone weakening in patients treated with ICIs to reduce the pain, inconvenience, and complications from fragility fractures.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.

I am starting FDA-approved anti-PD-1 immunotherapy, alone or with chemo, to cure my cancer.

3. Life expectancy of at least 12 months per the discretion of the treating physician.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anti-PD-1 immunotherapy, with bone mineral density scans conducted at baseline, 4-6 months, and after 12 months

12 months

3 visits for bone density scans

Follow-up

Participants are monitored for fracture incidence and changes in bone mineral density and plasma markers

1 month

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Anti-PD-1 Immunotherapy

How Is the Trial Designed?

Group I: Bone mineral density scans (DXA and HRpQCT) Experimental Treatment 2 Interventions

Patients undergo two research bone mineral density scans (DXA and HRpQCT) at three time points: baseline, 4-6 months during immunotherapy, and after 12 months of immunotherapy

Who Is Running the Clinical Trial?

Jessica Mezzanotte Sharpe

Lead Sponsor