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

Dan Zandberg

Status and phase: Completed; Phase 3

Conditions: Anal Cancer; Melanoma; HNSCC; Cholangiocarcinoma; Merkel Cell Carcinoma; Bladder Cancer; Gastric Cancer; Advanced Solid Tumors; Renal Cancer; Hepatocellular Carcinoma; Cervical Cancer; Colorectal Cancer; NSCLC

Treatments: Other: Discontinue PD-1/PD-L1-1 inhibitor; Drug: Continue PD-1/PD-L1 Inhibitors treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04157985

HCC 19-135

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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161 participants in 2 patient groups

Continue Treatment with PD-1/PD-L1 inhibitor

Active Comparator group

Description:

Continued standard of care treatment with PD-1/PD-L1 -1 checkpoint inhibitor after 12 months of checkpoint inhibitor treatment.

Treatment:

Drug: Continue PD-1/PD-L1 Inhibitors treatment

Discontinue Treatment with PD-1/PD-L1-1 inhibitor

Experimental group

Description:

Discontinued standard of care treatment with PD-1/PD-L1 -1 checkpoint inhibitor after 12 months of checkpoint inhibitor treatment.

Treatment:

Other: Discontinue PD-1/PD-L1-1 inhibitor