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PD-1/PD-L1 Inhibitor

PD-1/PD-L1 Inhibitor Therapy Duration for Cancer

Phase 3
Recruiting
Led By Jason Luke, MD
Research Sponsored by Jason J. Luke, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 4 months and 7.9 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Study Summary

This trial will study whether it is better to stop treatment with PD-1/PD-L1 therapy after one year or continue until disease progression.

Who is the study for?
This trial is for adults with advanced solid tumors (like lung, bladder, kidney cancer, etc.) who are responding to PD-1/PD-L1 inhibitors. They must have stable disease shown in scans within 6 weeks of joining and can't be on another clinical trial. Those with progressing disease or immune-related toxicity that stops treatment aren't eligible.Check my eligibility
What is being tested?
The study aims to find the best length of time for treating patients with PD-1/PD-L1 inhibitors. Participants will either stop treatment at one year or continue until their disease gets worse. The decision about which group a patient joins is made randomly.See study design
What are the potential side effects?
PD-1/PD-L1 inhibitors can cause side effects like fatigue, skin reactions, inflammation in organs such as lungs or intestines, hormonal gland problems (like thyroid), and changes in liver function tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am being treated with a PD-1/PD-L1 inhibitor for my advanced solid tumor cancer.
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I started treatment with a PD-1/PD-L1 inhibitor and another drug.
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My latest scans show my disease hasn’t worsened in the past 6 weeks.
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I agreed to possibly stop or continue immunotherapy after 1 year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 4 months and 7.9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and between 4 months and 7.9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS)
Progression-free Survival (PFS) (at between 2-3.9 months)
Progression-free Survival (PFS) (at between 4-7.9 months)
+1 more
Secondary outcome measures
Best Objective Response (BOR)
Incidence of irAEs (Immune-Related Adverse Events)
Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Discontinue Treatment with PD-1/PD-L1-1 inhibitorExperimental Treatment1 Intervention
Discontinued standard of care treatment with PD-1/PD-L1 -1 checkpoint inhibitor after 12 months of checkpoint inhibitor treatment.
Group II: Continue Treatment with PD-1/PD-L1 inhibitorActive Control1 Intervention
Continued standard of care treatment with PD-1/PD-L1 -1 checkpoint inhibitor after 12 months of checkpoint inhibitor treatment.

Find a Location

Who is running the clinical trial?

Jason J. Luke, MDLead Sponsor
4 Previous Clinical Trials
138 Total Patients Enrolled
Antoinette J WozniakLead Sponsor
Antoinette J Wozniak, MDLead Sponsor

Media Library

PD-1/PD-L1 Inhibitor (PD-1/PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04157985 — Phase 3
Bile Duct Cancer Research Study Groups: Discontinue Treatment with PD-1/PD-L1-1 inhibitor, Continue Treatment with PD-1/PD-L1 inhibitor
Bile Duct Cancer Clinical Trial 2023: PD-1/PD-L1 Inhibitor Highlights & Side Effects. Trial Name: NCT04157985 — Phase 3
PD-1/PD-L1 Inhibitor (PD-1/PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04157985 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What disease does Discontinue PD-1/PD-L1-1 inhibitor help patients with the most?

"Discontinue PD-1/PD-L1-1 inhibitor is an effective treatment for various cancers, such as malignant neoplasms and unresectable melanoma."

Answered by AI

Have patients participated in this type of treatment before?

"Discontinue PD-1/PD-L1-1 inhibitor has been the focus of medical research since 2008. The first study, sponsored by Hoffmann-La Roche, occurred that year and involved 720 participants. Following the success of this initial study, Discontinue PD-1/PD-L1-1 inhibitor received Phase 2 drug approval in 2009. As of 2021, there are 2081 active studies involving this medication taking place across 4025 cities in 78 countries."

Answered by AI

Could you please elaborate on the potential risks of taking a PD-1/PD-L1-1 inhibitor?

"Discontinue PD-1/PD-L1-1 inhibitor's safety is supported by multiple rounds of clinical data, giving it a score of 3."

Answered by AI
~219 spots leftby Oct 2026