Evaluating treatment duration of PD-1/PD-L1 inhibitors in advanced solid tumors
Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors
This study is trying to find out if patients with advanced solid tumors, like lung or bladder cancer, should keep taking a specific immunotherapy treatment for more than a year or stop after a year.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 578 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | pembrolizumab, nivolumab, atezolizumab, durvalumab, avelumab, ipilumumab, chemotherapy, immunotherapy |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04157985 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the optimal duration of PD-1/PD-L1 inhibitor treatment for patients with advanced solid tumors, including non-small cell lung cancer, bladder cancer, and others. Patients with stable disease will be randomized to either continue treatment beyond one year or to stop treatment after one year. The study is based on a significant interest from oncologists within the UPMC system, indicating a need for clarity on treatment duration. The results could provide valuable insights into the management of immunotherapy in these patients.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced solid tumors who are currently receiving PD-1/PD-L1 inhibitors and have stable disease.
Not a fit: Patients who are not currently receiving PD-1/PD-L1 inhibitors or those with progressive disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help establish guidelines for the duration of PD-1/PD-L1 inhibitor therapy, potentially reducing unnecessary treatment and associated side effects.
How similar studies have performed: Other studies have explored treatment durations for immunotherapy, but this specific approach to randomizing treatment duration in a large cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients must have an advanced solid tumor malignancy (specifically NSCLC, bladder, HNSCC, renal, melanoma, cervical, Merkel cell, MMR/MSI \[colon, rectal, cholangio, esophageal, ovarian, uterine\], anal, gastric and GE junction, hepatocellular, triple negative breast cancer) that is being treated with a PD-1/PD-L1 inhibitor including pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab according to standard of care treatment. * Patients who initially started treatment with another agent in combination with the PD-1/PD-L1 inhibitor, i.e. chemotherapy, ipilumumab, are eligible. * Patients must have at least stable disease as evidenced by scans performed within 6 weeks of randomization. * Signed Informed consent allowing randomization to stopping immunotherapy at 1 year ± 6 weeks versus continued treatment beyond 1 year. * Patients can have measurable or non-measurable disease per RECIST v1.1. * Patients cannot be enrolled in a clinical trial. Exclusion Criteria: * Patients with documented progressive disease prior to randomization. * Patients with an immune-related toxicity preventing the continuation of treatment beyond 1 year at the treating physician's discretion.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jason Luke, MD — UPMC Hillman Cancer Center
- Study coordinator: Ruth Jen, BSN
- Email: ruthj2@upmc.edu
- Phone: ruthj2@upmc.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.