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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04157985
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jason J. Luke, MD
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jason Luke, MD
Principal Investigator Affiliation	UPMC Hillman Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced Solid Tumors, NSCLC, Bladder Cancer, HNSCC, Renal Cancer, Melanoma, Anal Cancer, Colorectal Cancer, Cholangiocarcinoma, Gastric Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Cervical Cancer

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: 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.

Experimental: 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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Site Contact

Jennifer Ruth, BSN

[email protected]

412-623-8963

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