Anti-PD-1 Therapy for Melanoma and Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how certain immune cells, called T cells, respond during anti-PD-1/PD-L1 therapy, a type of immunotherapy. Researchers seek to determine if measuring specific markers in the blood can track treatment effectiveness and explain why some patients respond better than others. The trial involves collecting blood samples, and optionally stool samples, from participants with advanced melanoma, lung, or other cancers who are starting anti-PD-1/PD-L1 therapy. Individuals with advanced cancer who are about to begin this treatment might be suitable for the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any other anti-cancer therapy or investigational agents, except for the anti-PD-1/PD-L1 treatment.
What prior data suggests that anti-PD-1 therapy is safe for treating melanoma and lung cancer?
Research has shown that anti-PD-1 therapy, used for cancers like melanoma and lung cancer, is generally easier for patients to handle than traditional chemotherapy. Studies have found that about 20-25% of patients with these cancers experience significant positive results from these treatments.
However, like any treatment, side effects can occur. Some studies have found that anti-PD-1 therapies can cause serious side effects in a small number of patients, including tiredness, skin problems, or inflammation in different organs. While these side effects can happen, they are usually less common and often manageable.
Overall, while anti-PD-1 therapies show promise, weighing the benefits and risks is important. Anyone considering joining a clinical trial should talk with their healthcare provider to make an informed choice.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to understand how anti-PD-1 therapy affects T cell responses in cancers like melanoma and lung cancer. Unlike standard treatments, which often target cancer cells directly, this approach focuses on enhancing the body’s immune response to fight cancer. By closely monitoring blood and optional stool samples, researchers hope to uncover insights into how patients' immune systems react to this therapy, potentially leading to more personalized and effective cancer treatments in the future.
What evidence suggests that anti-PD-1 therapy could be an effective treatment for melanoma and lung cancer?
Research has shown that anti-PD-1 therapy effectively treats melanoma and non-small cell lung cancer (NSCLC). In advanced melanoma cases, about 40% of patients respond well to this treatment. For NSCLC, anti-PD-1 therapy has significantly improved survival rates, particularly in patients lacking a specific protein called PD-L1. Additionally, this treatment has led to noticeable improvements in about 20-25% of patients with melanoma, NSCLC, or kidney cancer. These findings suggest that anti-PD-1 therapy can help the immune system fight these cancers more effectively. Researchers will observe participants in this trial through blood and stool sample collection to further understand the effects of anti-PD-1 therapy.26789
Who Is on the Research Team?
Svetomir N. Markovic, MD, PhD
Principal Investigator
Mayo Clinic in Rochester
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial blood sample collection and baseline measurements for Bim levels and other markers
Monitoring
Ongoing blood sample collection and monitoring of T cell responses and resistance mechanisms during anti-PD-1 therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Anti-PD-1 Therapy
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo blood sample collection throughout the study. Patients also undergo optional stool sample collection and have their medical records reviewed on study. In addition, patients provide previously-collected tissue sample, if available.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Association of anti-PD-(L)1 treatment duration to efficacy in ...
We investigated the association of limited anti-PD-(L)1 treatment duration to therapy efficacy in melanoma and non-small cell lung cancer (NSCLC) patients.
PD-1 inhibitors versus PD-L1 inhibitors in PD-L1–negative ...
Anti-PD-1 agents significantly improved OS in PD-L1-negative patients with advanced NSCLC (HR 0.75, 95% CI 0.67–0.83, p < 0.01). In contrast, ...
Immune checkpoint inhibition in metastatic or non- ...
In metastatic melanoma, treatment with anti-PD-1 antibodies results in overall response rates (ORR) of about 40 % [5], [10] and long-term ...
Safety, Activity, and Immune Correlates of Anti–PD-1 ...
Anti–PD-1 antibody produced objective responses in approximately one in four to one in five patients with non–small-cell lung cancer, melanoma, or renal-cell ...
a systematic review and individual patient data meta-analysis
The estimated 12-month PFS was 33.5% (95% CI: 25.9%, 43.3%) for the anti-PD1 arm versus 30.3% (95% CI: 21.2%, 43.4%) for the anti-PD1 and RT arm ...
Safety and Tolerability of PD‐1/PD‐L1 Inhibitors Compared ...
Overall, PD1/PD‐L1 inhibitors in these clinical trials were better tolerated than chemotherapy. CTCAE has been the standard method to evaluate toxicities and ...
A study on adverse drug events of PD-1/PD-L1 inhibitors in ...
Data on ADEs associated with PD-1/PD-L1 inhibitors for lung cancer treatment were collected from FDA Adverse Event Reporting System (FAERS) ...
Treatment-Related Adverse Events of PD-1 and PD-L1 ...
PD-1 inhibitors were associated with a higher mean incidence of grade 3 or higher adverse events compared with PD-L1 inhibitors.
Efficacy, prognosis and safety analysis of anti-PD-1/PD-L1 ...
Our study aimed to explore the efficacy, prognosis and safety of patients who received anti-programmed cell death-1/programmed cell death ligand 1 (anti-PD-1/ ...
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