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PD-1 Inhibitor

PD-1 Inhibitor Therapy Duration for Melanoma (STOP-GAP Trial)

Phase 3

Recruiting

Research Sponsored by Canadian Cancer Trials Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treated with surgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.

Treated with stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

STOP-GAP Trial Summary

This trial is testing whether an immunotherapy drug works better when taken continuously or intermittently for people with metastatic melanoma.

Who is the study for?

Adults with metastatic melanoma who are eligible for government-funded PD-1 inhibitor therapy can join. They must have stable disease, including brain metastases if present, and be willing to complete questionnaires in English or French. Those not willing to potentially pause treatment or with contraindications to PD-1 inhibitors cannot participate.Check my eligibility

What is being tested?

The trial is testing two methods of administering a PD-1 inhibitor: intermittently stopping and restarting treatment versus continuous use without breaks. The goal is to see which method better extends the lives of patients with metastatic melanoma.See study design

What are the potential side effects?

PD-1 inhibitors may cause immune-related side effects such as inflammation in various organs, skin reactions, fatigue, hormonal changes, and increased risk of infections. Specific side effects depend on individual patient responses.

STOP-GAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery for my condition and there's no sign it's gotten worse or that I have new brain tumors.

Select...

I had radiosurgery for my brain tumor and it hasn't grown since.

Select...

My melanoma cannot be surgically removed and has spread.

Select...

I am eligible for treatment with a PD-1 inhibitor as per government guidelines.

Select...

My brain metastases are stable.

Select...

I started PD-1 inhibitor treatment less than 16 weeks ago or haven't started yet.

STOP-GAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival

Secondary outcome measures

Duration of response using RECIST 1.1 / Immune-Related RECIST (irRECIST)

Economic evaluation consisting of both healthcare utilization and health utilities measured by the EQ-5D questionnaire

Number and severity of adverse events using CTCAE v 4.0

+3 more

STOP-GAP Trial Design

2Treatment groups

Active Control

Group I: Arm 1: Intermittent PD-1 Inhibitor therapyActive Control1 Intervention

Any PD-1 inhibitor that is commercially available, government approved and publicly funded. Dose as recommended by the manufacturer.

Group II: Arm 2: Continuous PD-1 Inhibitor therapyActive Control1 Intervention

Any PD-1 inhibitor that is commercially available, government approved and publicly funded. Dose as recommended by the manufacturer.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor

124 Previous Clinical Trials

66,839 Total Patients Enrolled

3 Trials studying Melanoma

3,013 Patients Enrolled for Melanoma

Melanoma and Skin Cancer Trials LimitedOTHER

16 Previous Clinical Trials

6,058 Total Patients Enrolled

12 Trials studying Melanoma

5,526 Patients Enrolled for Melanoma

Xinni SongStudy ChairOttawa Hospital Research Institute

Media Library

PD-1 inhibitor (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02821013 — Phase 3

Melanoma Research Study Groups: Arm 1: Intermittent PD-1 Inhibitor therapy, Arm 2: Continuous PD-1 Inhibitor therapy

Melanoma Clinical Trial 2023: PD-1 inhibitor Highlights & Side Effects. Trial Name: NCT02821013 — Phase 3

PD-1 inhibitor (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02821013 — Phase 3

Frequently Asked Questions

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

Has the FDA cleared Arm 2: Continuous PD-1 Inhibitor therapy for use?

"Arm 2: Continuous PD-1 Inhibitor therapy was given a safety score of 3. This is due to the fact that Phase 3 trials have yielded some data supporting efficacy as well as multiple rounds of data supporting safety."

Answered by AI

Are there multiple facilities conducting this research within the state?

"17 different medical centres across Canada are currently recruiting patients for this trial. If you decide to participate in the study, it would be advantageous to choose a site near your home to limit travel requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Duration of Anti-PD-1 Therapy in Metastatic Melanoma

2016. "Duration of Anti-PD-1 Therapy in Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02821013.

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