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

NCT ID: NCT04157985

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2025-11-07

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continue Treatment with PD-1/PD-L1 inhibitor

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

Group Type: ACTIVE_COMPARATOR

Continue PD-1/PD-L1 Inhibitors treatment

Intervention Type: DRUG

Continued treatment with PD-1/PD-L1-1 inhibitor

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

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

Group Type: EXPERIMENTAL

Discontinue PD-1/PD-L1-1 inhibitor

Intervention Type: OTHER

Discontinued treatment with PD-1/PD-L1-1 inhibitor

Interventions

Continue PD-1/PD-L1 Inhibitors treatment

Continued treatment with PD-1/PD-L1-1 inhibitor

Intervention Type: DRUG

Discontinue PD-1/PD-L1-1 inhibitor

Discontinued treatment with PD-1/PD-L1-1 inhibitor

Intervention Type: OTHER

Other Intervention Names

Keytruda (pembrolizumab); Optiva (nivolumab); Tecentriq (atezolizumab); Yervoy (ipilimumab); LIBTAYO (cemiplimab)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dan Zandberg

OTHER

Sponsor Role: lead

Responsible Party

Dan Zandberg

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dan Zandberg, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Hillman Cancer Center

Locations

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

HCC 19-135

Identifier Type: -

Identifier Source: org_study_id