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Brief Title: Evaluation of the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors

A Randomized Non-inferiority Trial Evaluating the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors

INTRODUCTION

  • Org Study ID: 19-135
  • Secondary ID: N/A
  • NTC ID: NCT04157985
  • Sponsor: Antoinette J Wozniak

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.

  • Overall Status
    Recruiting
  • Start Date
    November 15, 2019
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Time to next treatment

Primary Outcome 1 - Timeframe: Up to 36 months

CONDITION

  • Advanced Solid Tumors
  • NSCLC
  • Bladder Cancer
  • HNSCC
  • Renal Cancer
  • Melanoma
  • Anal Cancer
  • Colorectal Cancer
  • Cholangiocarcinoma
  • Gastric Cancer
  • Hepatocellular Carcinoma

ELIGIBILITY

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 ± 4 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Antoinette J Wozniak, MD, FACP

Role: Principal Investigator

Affiliation: UPMC Hillman Cancer Center

Overall Contact

Name: Antoinette J Wozniak, MD, FACP

Phone: ruthj2@upmc.edu

Email: ruthj2@upmc.edu

LOCATION

Facility Status Contact
Facility: UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: Contact
Jennifer Ruth, BSN
412-623-8963
ruthj2@upmc.edu