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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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 4 months and 7.9 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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
Select...
I am being treated with a PD-1/PD-L1 inhibitor for my advanced solid tumor cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
Cervical Cancer Research Study Groups: Discontinue Treatment with PD-1/PD-L1-1 inhibitor, Continue Treatment with PD-1/PD-L1 inhibitor
Cervical 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
~251 spots leftby Oct 2028
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