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

  • STATUS
    Recruiting
  • End date
    Oct 28, 2025
  • participants needed
    578
  • sponsor
    Antoinette J Wozniak
Updated on 28 January 2021
cancer
measurable disease
pembrolizumab
pd-l1
nivolumab
durvalumab
cancer chemotherapy
solid tumour
solid tumor
atezolizumab

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.

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.

Details
Condition Non-Small Cell Lung Cancer, Adenocarcinoma, urinary tract neoplasm, Colorectal Cancer, Cholangiocarcinoma, Malignant neoplasm of kidney, Rectal disorder, Rectal Cancer, Nephropathy, bladder cancer, bladder disorder, melanoma, skin cancer, HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA, Gastropathy, Gastric Cancer, Anal Cancer, Stomach Discomfort, Metastatic Melanoma, Kidney Disease (Pediatric), Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Advanced Solid Tumors, Squamous Cell Carcinoma of the Head and Neck, Urothelial Cancer, Squamous Cell Carcinoma of Head and Neck, Gastric Carcinoma, HNSCC, Kidney Cancer, Malignant Melanoma, Liver Cancer, Malignant Adenoma, Kidney Disease, Stomach Cancer, Bladder Disorders, Renal Cancer, Bladder Carcinoma, Urologic Cancer, colorectal neoplasm, anal carcinoma, gastric cancers, carcinoma of the bladder, colorectal cancers, nsclc, cancer, renal, liver cell carcinoma, cancer, colorectal, colorectal tumor, tumors, colorectal, bladder tumor
Treatment Continue PD-1/PD-L1 Inhibitors treatment, Discontinue PD-1/PD-L1-1 inhibitor
Clinical Study IdentifierNCT04157985
SponsorAntoinette J Wozniak
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note