578 Participants Needed

PD-1/PD-L1 Inhibitor Therapy Duration for Cancer

RJ
Overseen ByRuth Jen, BSN
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Jason J. Luke, MD
Must be taking: PD-1/PD-L1 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

What 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.56789

How 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.25101112

Research Team

Medical Oncology | Dept of Medicine ...

Jason Luke, MD

Principal Investigator

UPMC Hillman Cancer Center

Eligibility 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.
See 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.

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

Treatment Details

Interventions

  • PD-1/PD-L1 Inhibitor
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

Jason J. Luke, MD

Lead Sponsor

Trials
5
Recruited
720+

Antoinette J Wozniak

Lead Sponsor

Trials
1
Recruited
580+

Antoinette J Wozniak, MD

Lead Sponsor

Trials
1
Recruited
580+

Findings from Research

In a meta-analysis of 27 randomized controlled trials involving 15,590 patients with advanced non-small cell lung cancer, treatment effect sizes for progression-free survival (PFS) and overall survival (OS) were found to be comparable, suggesting that PFS can be a reliable endpoint in clinical trials.
However, the analysis indicated that PFS may not be as reliable for trials using immunotherapy as a second-line treatment, highlighting the need for caution when interpreting PFS data without OS outcomes in these cases.
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.Zhou, Z., Ren, S., Chen, L., et al.[2022]
In a study of 13 patients with various cancers who discontinued anti-PD(L)1 therapy after achieving stable disease, the median progression-free survival was 24.4 months, indicating that some patients can maintain disease control even after stopping treatment for a median of 12.6 months.
Upon retreatment after disease progression, 25% of patients achieved a partial response and 75% maintained stable disease, suggesting that resuming anti-PD(L)1 therapy can be effective and safe, as no severe adverse events were reported.
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.Bernard-Tessier, A., Baldini, C., Martin, P., et al.[2019]
In a systematic review of 24 trials involving over 14,860 patients, PD-1/PD-L1 inhibitors significantly reduced the risk of death compared to conventional treatments, with a hazard ratio of 0.72, indicating a strong efficacy across various tumor types.
Patients with positive PD-L1 expression (≥1%) showed improved overall survival when treated with anti-PD-1/PD-L1 monotherapy, particularly in nonsmall cell lung cancer, suggesting that PD-L1 expression can be a useful biomarker for selecting patients for this type of treatment.
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.Chen, XJ., Yuan, SQ., Duan, JL., et al.[2022]

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]
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]
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]
Undetectable circulating tumor DNA (ctDNA) levels correlate with favorable outcome in metastatic melanoma patients treated with anti-PD1 therapy. [2023]
Early PD-1 Therapy Discontinuation in Responding Metastatic Cancer Patients. [2019]
Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. [2023]
Treatment-Related Adverse Events of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-analysis. [2022]
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]
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]
Pursuit or discontinuation of anti-PD1 after 2 years of treatment in long-term responder patients with non-small cell lung cancer. [2023]
Real-world experience with elective discontinuation of PD-1 inhibitors at 1 year in patients with metastatic melanoma. [2023]
Limited-duration anti-PD-1 therapy for patients with metastatic melanoma. [2020]
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