NCT04157985CompletedPhase 3
Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 161 (actual)
- First submitted
- 6 Nov 2019
- Start date
- 15 Nov 2019
- Primary completion date
- 14 Oct 2025
- Lead sponsor
- Dan Zandberg
- Diseases
- Head and neck cancer, Kidney cancer, Bladder cancer, Melanoma, Cervical cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer
- NCT number
- NCT04157985
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 161
- From 15 Nov 2019 to the primary completion date, 14 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with documented progressive disease prior to randomization.
Other
- Patients with an immune-related toxicity preventing the continuation of treatment beyond 1 year at the treating physician's discretion.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.