PD-1/PD-L1 Inhibitor Therapy Duration for Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Jason J. Luke, MD
Must be taking: PD-1/PD-L1 inhibitors
Disqualifiers: Progressive disease, Immune toxicity, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?Based on the overwhelming positive response to this survey and the large number of patients being treated with PD-1/PD-L1 therapy in the UPMC system, the investigators are proposing a trial that will randomize patients who have disease stability to stop treatment at 1 year or continue treatment until disease progression. The investigators anticipate that the results of this study will answer questions regarding the optimal duration of treatment. therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. It focuses on patients already being treated with PD-1/PD-L1 inhibitors, so you may continue those treatments.
What data supports the effectiveness of the PD-1/PD-L1 Inhibitor drug for cancer?
Research shows that PD-1/PD-L1 inhibitors can improve survival in 10-40% of advanced cancer patients, and they have been particularly effective in treating advanced non-small cell lung cancer and metastatic melanoma.
12345What safety data exists for PD-1/PD-L1 inhibitor therapy in humans?
PD-1/PD-L1 inhibitors have been studied for their safety in treating various cancers, including non-small cell lung cancer and melanoma. Common side effects include immune-related adverse events, which can affect different body systems, but there are management strategies to handle these. Overall, these treatments have shown a balance of safety and effectiveness in clinical trials.
56789How is PD-1/PD-L1 Inhibitor therapy different from other cancer treatments?
PD-1/PD-L1 Inhibitor therapy is unique because it involves immune checkpoint inhibitors that help the immune system recognize and attack cancer cells. Unlike traditional treatments, the optimal duration for this therapy is still being studied, with some trials exploring shorter treatment periods to balance effectiveness and reduce side effects.
25101112Eligibility Criteria
This trial is for adults with advanced solid tumors (like lung, bladder, kidney cancer, etc.) who are responding to PD-1/PD-L1 inhibitors. They must have stable disease shown in scans within 6 weeks of joining and can't be on another clinical trial. Those with progressing disease or immune-related toxicity that stops treatment aren't eligible.Inclusion Criteria
I am being treated with a PD-1/PD-L1 inhibitor for my advanced solid tumor cancer.
My latest scans show my disease hasn’t worsened in the past 6 weeks.
Patients can have either detectable or undetectable disease according to a specific set of guidelines.
+3 more
Exclusion Criteria
My doctor stopped my immune therapy due to side effects.
You have shown signs that your disease is getting worse before starting the trial.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive PD-1/PD-L1 inhibitor treatment for 12 months
12 months
Follow-up
Participants are monitored for progression-free survival and overall survival
Up to 36 months
Extension
Participants may continue or discontinue treatment based on randomization after 12 months
Up to 36 months
Participant Groups
The study aims to find the best length of time for treating patients with PD-1/PD-L1 inhibitors. Participants will either stop treatment at one year or continue until their disease gets worse. The decision about which group a patient joins is made randomly.
2Treatment groups
Experimental Treatment
Active Control
Group I: Discontinue Treatment with PD-1/PD-L1-1 inhibitorExperimental Treatment1 Intervention
Discontinued standard of care treatment with PD-1/PD-L1 -1 checkpoint inhibitor after 12 months of checkpoint inhibitor treatment.
Group II: Continue Treatment with PD-1/PD-L1 inhibitorActive Control1 Intervention
Continued standard of care treatment with PD-1/PD-L1 -1 checkpoint inhibitor after 12 months of checkpoint inhibitor treatment.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UPMC Hillman Cancer CenterPittsburgh, PA
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Who Is Running the Clinical Trial?
Jason J. Luke, MDLead Sponsor
Antoinette J WozniakLead Sponsor
Antoinette J Wozniak, MDLead Sponsor
References
Differences in treatment effect size between progression-free survival and overall survival in anti-PD-1/PD-L1 inhibitors-based trials in advanced NSCLC: a systematic review and meta-analysis. [2022]To investigate the differences in treatment effect sizes between progression-free survival (PFS) and overall survival (OS) in advanced non-small cell lung cancer (NSCLC) treated with programmed cell death 1 (PD-1) and its ligand (PD-L1) blockade-based treatments.
Outcomes of long-term responders to anti-programmed death 1 and anti-programmed death ligand 1 when being rechallenged with the same anti-programmed death 1 and anti-programmed death ligand 1 at progression. [2019]Long-term responders have been observed with anti-programmed death 1 and anti-programmed death ligand 1 (anti-PD(L)1). Optimal duration of therapy in responding and stable disease (SD) patients is unclear with various attitudes encompassing treatment until progression disease, stopping therapy after a defined timeframe.
The Value of PD-L1 Expression in Predicting the Efficacy of Anti-PD-1 or Anti-PD-L1 Therapy in Patients with Cancer: A Systematic Review and Meta-Analysis. [2022]Recent trials have shown an overall survival (OS) benefit in 10-40% advanced cancer patients treated with programmed cell death 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors. Here, we aimed to evaluate the relationship between PD-L1 expression and the therapeutic efficacy of PD-1 or PD-L1 inhibitors in patients with cancer with recurrent or metastatic disease, compared with control treatments.
Undetectable circulating tumor DNA (ctDNA) levels correlate with favorable outcome in metastatic melanoma patients treated with anti-PD1 therapy. [2023]Treatment with anti-PD1 monoclonal antibodies improves the survival of metastatic melanoma patients but only a subgroup of patients benefits from durable disease control. Predictive biomarkers for durable benefit could improve the clinical management of patients.
Early PD-1 Therapy Discontinuation in Responding Metastatic Cancer Patients. [2019]Most clinical trials have investigated PD-(L)1 agents until disease progression or severe side effects, but the optimal duration of the treatment remains to be elucidated. Our institutional guideline has restricted maximal PD-(L)1 therapy length to 6 months, and therefore our cohort provides a unique opportunity to investigate the effects of short PD-1 therapy.
Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. [2023]Immune checkpoint antibodies that augment the programmed cell death protein 1 (PD-1)/PD-L1 pathway have demonstrated antitumor activity across multiple malignancies, and gained recent regulatory approval as single-agent therapy for the treatment of metastatic malignant melanoma and nonsmall-cell lung cancer. Knowledge of toxicities associated with PD-1/PD-L1 blockade, as well as effective management algorithms for these toxicities, is pivotal in order to optimize clinical efficacy and safety. In this article, we review selected published and presented clinical studies investigating single-agent anti-PD-1/PD-L1 therapy and trials of combination approaches with other standard anticancer therapies, in multiple tumor types. We summarize the key adverse events reported in these studies and their management algorithms.
Treatment-Related Adverse Events of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-analysis. [2022]Programmed cell death (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors have been increasingly used in cancer therapy. Understanding the treatment-related adverse events of these drugs is critical for clinical practice.
Immune-Related Adverse Events and Their Association With the Effectiveness of PD-1/PD-L1 Inhibitors in Non-Small Cell Lung Cancer: A Real-World Study From China. [2022]Programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitors are increasingly used in China, but no real-world data are available about the immune-related adverse events (irAEs). This real-world retrospective study aimed to assess the safety and effectiveness of PD-1/PD-L1 inhibitors in patients with non-small cell lung cancer (NSCLC) and to analyze the association between irAEs and effectiveness.
The safety of first and subsequent lines of PD-1/PD-L1 inhibitors monotherapy in non-small cell lung cancer patients: a meta-analysis. [2022]In both first or subsequent therapy of patients with non-small cell lung cancer (NSCLC), some programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) inhibitors have shown prominent efficacy and safety. However, the disease spectra of side effects in different therapy time might exist heterogeneity. In this meta-analysis, we assessed and compared the safety of PD-1/PD-L1 inhibitors in first or subsequent line therapy. And the system-specific disease spectra of both treatment-related adverse events (trAEs) and immune-related adverse events (irAEs) were summarized.
Pursuit or discontinuation of anti-PD1 after 2 years of treatment in long-term responder patients with non-small cell lung cancer. [2023]The optimal duration of immune checkpoint inhibitor (ICI) treatment for patients with advanced non-small cell lung cancer (NSCLC) remains to be determined. Treatment durations in cornerstone phase 3 clinical trials vary between a fixed 2-year duration and pursuit until disease progression. Clinical practices may thus differ according to the attending physician.
Real-world experience with elective discontinuation of PD-1 inhibitors at 1 year in patients with metastatic melanoma. [2023]Randomized trials evaluating programmed cell death protein 1 (PD-1) inhibitors in metastatic melanoma either permitted treatment for 2 years (pembrolizumab) or more (nivolumab). The optimal duration of therapy is currently unknown due to limited data, and shorter therapies may be effective.
Limited-duration anti-PD-1 therapy for patients with metastatic melanoma. [2020]Purpose: To date, no clinical study has reported on the optimal treatment duration of PD-1 blockade in patients with metastatic melanoma. Worldwide, concern has been expressed that due to the high cost of anti-PD-1 therapy, it is not available for all patients. After approval of anti-PD-1 therapy as a first-line treatment, the Helsinki University Hospital institutional board for new drugs decided to treat the first patient cohort within a limited treatment duration program in order to offer this treatment to as many patients as possible.Patients and methods: The first 40 patients with metastatic melanoma initiating treatment at Helsinki University Hospital were to be treated within a six months maximum limited duration program. Patient follow-up was systematic according to a prospectively planned treatment protocol to enable evaluation of treatment efficacy and the safety of this treatment approach.Results: Thirty-eight patients were treated within the program. Seventeen out of these 38 patients completed the six-month regimen. Five discontinued treatment early due to toxicity, and 16 discontinued due to progressive disease. The response rate (RR) for all patients was 39%, but only 33% of these responses are ongoing. Median progression-free survival (PFS) for patients who completed the six-month therapy was 12 months (range, two to 44 months), and median overall survival (OS) has not yet been reached.Conclusions: Although RR is comparable to published data, the response duration is shorter. Based on our results, limiting treatment to only six months may increase the risk of shortening response duration.