Study on the Duration of PD-1/PD-L1 Inhibitor Treatment in Advanced Solid Tumors

Sponsor: Jason J. Luke, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04157985

Provider View

This clinical trial is exploring whether patients with stable advanced solid tumors should stop PD-1/PD-L1 inhibitor treatment after one year or continue until the disease progresses. The study aims to find the best treatment duration for these therapies.

Patient Parameters

Program Overview

This study is being conducted to determine the optimal length of treatment with PD-1/PD-L1 inhibitors for patients with advanced solid tumors. Patients who have stable disease will be randomly assigned to either stop treatment after one year or continue until their disease progresses. The goal is to understand how long patients should be treated with these therapies for the best outcomes.

Description

In the UPMC system, around 2,300 patients received PD-1/PD-L1 therapy for various advanced solid tumors last year, and this number is expected to grow. A survey of 60 oncologists showed strong interest in a trial to determine the best length of treatment with these therapies. Most doctors agreed to participate in a study to see if stopping immunotherapy after one year is feasible. This trial will help answer important questions about how long patients should continue treatment with PD-1/PD-L1 inhibitors.

Eligibility Criteria

Inclusion Criteria

  • Have an advanced solid tumor being treated with a PD-1/PD-L1 inhibitor like pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab.
  • May have started treatment with another drug alongside the PD-1/PD-L1 inhibitor, such as chemotherapy or ipilumumab.
  • Must have stable disease as shown by scans within 6 weeks before joining the study.
  • Must agree to be randomly assigned to either stop treatment after one year or continue beyond one year.
  • Can have measurable or non-measurable disease according to specific criteria.
  • Cannot be part of another clinical trial.

Exclusion Criteria

  • Have disease that has worsened before joining the study.
  • Have experienced immune-related side effects that prevent continuing treatment beyond one year, as decided by the doctor.

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