COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-11-15
Study Completion:2025-11-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04157985

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Patients who initially started treatment with another agent in combination with the PD-1/PD-L1 inhibitor, i.e. chemotherapy, ipilumumab, are eligible.
  3. * Patients must have at least stable disease as evidenced by scans performed within 6 weeks of randomization.
  4. * Signed Informed consent allowing randomization to stopping immunotherapy at 1 year ± 6 weeks versus continued treatment beyond 1 year.
  5. * Patients can have measurable or non-measurable disease per RECIST v1.1.
  6. * Patients cannot be enrolled in a clinical trial.
  1. * Patients with documented progressive disease prior to randomization.
  2. * Patients with an immune-related toxicity preventing the continuation of treatment beyond 1 year at the treating physician's discretion.

Contacts and Locations

Principal Investigator

Dan Zandberg, MD
PRINCIPAL_INVESTIGATOR
UPMC Hillman Cancer Center

Study Locations (Sites)

UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: Dan Zandberg

  • Dan Zandberg, MD, PRINCIPAL_INVESTIGATOR, UPMC Hillman Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-15
Study Completion Date2025-11-07

Study Record Updates

Study Start Date2019-11-15
Study Completion Date2025-11-07

Terms related to this study

Additional Relevant MeSH Terms

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