25 Participants NeededMy employer runs this trial

Anti-PD-1 Immunotherapy for Cancer

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Overseen ByJessica Sharpe, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jessica Mezzanotte Sharpe
Must be taking: Anti-PD-1 therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how anti-PD-1 immunotherapy affects bones. Researchers aim to determine if this treatment weakens bones and raises the risk of fractures. Special scans will monitor bone strength over time. Suitable participants include those beginning anti-PD-1 therapy, either alone or with chemotherapy, who do not have pre-existing bone conditions like osteoporosis.

As an unphased study, this trial provides a unique opportunity to enhance understanding of the broader effects of anti-PD-1 therapy on bone health.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on treatments like denosumab, zoledronic acid, or other bisphosphonates, you cannot have used them in the last six months to participate.

What prior data suggests that these imaging techniques are safe for assessing bone density?

Studies have shown that anti-PD-1 immunotherapy, a treatment for various cancers, can cause some side effects. Research indicates that about 16.7% of patients experience serious side effects, such as inflammation of organs, which can lead to organ damage or problems. These side effects often occur because the immune system becomes too active. Some patients might have treatable issues, like joint pain, while others might develop long-term conditions, such as hypothyroidism, requiring ongoing treatment.

There is also concern that this therapy might weaken bones, increasing the risk of fractures. However, these treatments have been approved for many cancers, indicating they are generally considered safe by experts. Like any treatment, there are risks, and ongoing research aims to better understand and manage these side effects.12345

Why are researchers excited about this trial?

Unlike the standard cancer treatments, such as chemotherapy and radiation that directly attack cancer cells, anti-PD-1 immunotherapy acts by empowering the patient's immune system to recognize and fight cancer cells more effectively. This treatment is unique because it uses a mechanism that blocks the PD-1 protein on T-cells, preventing cancer cells from "hiding" from the immune system. Researchers are excited about this approach because it has the potential to provide a more targeted and less toxic treatment option, potentially leading to prolonged and durable responses in patients with various types of cancer.

What evidence suggests that Anti-PD-1 Immunotherapy might affect bone health in cancer patients?

Research has shown that anti-PD-1 immunotherapy can effectively treat different types of cancer. Studies have found that these treatments can help patients live longer without their cancer worsening and can also improve overall survival. For instance, one study found that 41% of patients with high levels of a specific marker (PD-1 mRNA) experienced tumor shrinkage. Another study demonstrated that anti-PD-1 therapy led to better survival rates than anti-PD-L1 therapy in patients with solid tumors. However, while these treatments are promising, they can cause side effects, such as inflammation that might affect various organs.26789

Are You a Good Fit for This Trial?

This trial is for adults (18+) with cancer who are about to start or have just started anti-PD-1 immunotherapy, alone or with chemo, as part of their standard treatment. Participants should have a life expectancy of at least one year.

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

Trial Overview

The study uses two bone imaging tests—DXA and HRpQCT—to track changes in bone strength and structure in patients receiving anti-PD-1 immunotherapy, either by itself or combined with chemotherapy.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Bone mineral density scans (DXA and HRpQCT)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jessica Mezzanotte Sharpe

Lead Sponsor

Citations

Effectiveness and safety of PD-1/PD-L1 inhibitors in the ... - PMC

All of these results suggest that PD-1 inhibitors were better at improving the PFS, OS, and ORR of cancer patients, and they may have potential as powerful ...

Efficacy of anti-PD1 therapy in PD1-high mRNA tumors ...

Efficacy of anti-PD1 monotherapy across cancer types following PD1 mRNA selection. In the PD1-high cohort, 23 of 56 patients (41.1%) showed tumor shrinkage, ...

A real-world study on the efficacy and safety of low-dose ...

Conclusions Low-dose PD-1 monoclonal antibody therapy demonstrated comparable efficacy to standard-dose therapy with a lower incidence of severe ...

Immunotherapy: Precision Medicine in Action

Immunotherapy has shown success in 15 different types of cancers including lung cancer, head and neck cancer, bladder cancer, kidney cancer, and Hodgkin ...

Immunotherapy with Anti-PD-1 Effective for Patients ...

Anti-PD-1 exhibited better survival outcomes than anti-PD-L1 in patients with solid tumors in either overall, monotherapy, or combination therapy settings.

Comparative safety of PD-1 and PD-L1 inhibitors in advanced ...

Patients receiving PD-L1 inhibitors were older on average and had markedly higher proportions of lung cancer and liver cancer, whereas patients ...

Article Efficacy and safety of anti-PD-1 versus anti-PD-L1 in ...

Anti-PD-1 therapy demonstrated better clinical outcomes and higher incidence of grade 3–5 immune-related adverse events to anti-PD-L1 in perioperative settings.

Evaluation of the efficacy and safety of anti-PD-1 and ... - PMC

In overall, ORR in the whole population with PD-1 blockage treatment is 22.5% (95% CI: 17.6% to 28.2%). Additionally, the rate of Grade 3-4 AEs is 16.7% (95% CI ...

Updated Efficacy Outcomes of Anti-PD-1 Antibodies plus ...

Anti-PD-1 antibodies plus multikinase inhibitors showed promising antitumor activity with longer follow-up, irrespective of liver metastases. Meanwhile, ...