Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors

Introduction

• Org Study ID: HCC 19-135
• NTC ID: NCT04157985
• Lead Sponsor Name: University of Pittsburgh
• Status: RECRUITING

Conditions

• Renal Cell Carcinoma

Brief 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.

Eligibility 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 iRECIST.
* 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.