Trials / Completed
CompletedNCT04157985
Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 161 (actual)
- Sponsor
- Dan Zandberg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Within the UPMC system, approximately 2,300 patients received PD-1/PD-L1 therapy for a variety of advanced solid tumors within the past year. It is anticipated that this number will increase as the clinical indications for treatment with these agents also increase. The investigators conducted a survey of 60 Medical Oncologists within the UPMC system regarding their interest in a trial that will attempt to address the question of optimal length of PD-1/PD-L1 treatment. Fifty-two (86.7%) physicians indicated that they would participate in a clinical trial that had a primary goal of determining whether it was feasible to stop immunotherapy after 1 year of treatment.
Conditions
- Advanced Solid Tumors
- NSCLC
- Bladder Cancer
- HNSCC
- Renal Cancer
- Melanoma
- Anal Cancer
- Colorectal Cancer
- Cholangiocarcinoma
- Gastric Cancer
- Hepatocellular Carcinoma
- Merkel Cell Carcinoma
- Cervical Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Continue PD-1/PD-L1 Inhibitors treatment | Continued treatment with PD-1/PD-L1-1 inhibitor |
| OTHER | Discontinue PD-1/PD-L1-1 inhibitor | Discontinued treatment with PD-1/PD-L1-1 inhibitor |
Timeline
- Start date
- 2019-11-15
- Primary completion
- 2025-10-14
- Completion
- 2025-11-07
- First posted
- 2019-11-08
- Last updated
- 2025-12-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04157985. Inclusion in this directory is not an endorsement.