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

Launched by JASON J. LUKE, MD · Nov 6, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the best length of treatment with a type of cancer therapy called PD-1/PD-L1 inhibitors, which are used for various advanced solid tumors, including lung, bladder, and melanoma cancers. The goal is to find out if patients who have stable disease can safely stop treatment after one year or if they should continue until their disease gets worse. Patients will be randomly assigned to either stop treatment at one year or keep going for a longer period.

To be eligible for this trial, participants must have an advanced solid tumor and be receiving treatment with a PD-1/PD-L1 inhibitor. They should also have stable disease based on recent scans. Participants will need to sign a consent form to agree to being part of the study. Throughout the trial, patients will be closely monitored to see how their disease responds to the treatment, and they will receive support from the medical team. This research aims to provide important insights into the best duration for this type of cancer treatment, which could improve care for future patients.

Gender

ALL

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 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.