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Checkpoint Inhibitor

Radiotherapy + Immunotherapy for Melanoma Brain Metastasis

Phase 1

Recruiting

Led By Mohammad K Khan, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Have at least one measurable extra-cranial site of disease

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 or Karnofsky performance status >= 70%

Must not have

Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent

Implanted pacemaker, defibrillator, deep brain stimulator, or documented clinically significant arrhythmias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from srs to death, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new combination of treatments for melanoma that has spread to the brain. It uses precise radiation, immune-boosting drugs, and a device that sends electric fields to disrupt cancer cells. The goal is to see if this combination is safe and more effective than current treatments.

Who is the study for?

This trial is for adults with melanoma that has spread to the brain. Participants must be in good health otherwise, able to consent, and have not received certain treatments recently. They should also agree to use birth control if of childbearing potential and need a caregiver or self-support for device management.

What is being tested?

The study tests combining stereotactic radiosurgery (precise radiation therapy) with immune checkpoint inhibitors (drugs like pembrolizumab, nivolumab, ipilimumab) and NovoTTF-100M (a device creating electric fields to disrupt cancer cells). The goal is to see if this combo works better than current methods.

What are the potential side effects?

Possible side effects include typical reactions from immunotherapy such as fatigue, skin reactions, inflammation in organs; from radiosurgery like headaches or scalp irritation; and from NovoTTF-100M like mild skin irritation under electrode areas.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor outside of my brain that can be measured.

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I am mostly active and can care for myself.

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My hemoglobin level is at least 9 g/dL without needing transfusions or EPO recently.

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I have been diagnosed with malignant melanoma.

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My diagnosis is melanoma confirmed by tissue analysis.

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I am 22 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer treatment in the last 2 weeks or I've recovered from its side effects.

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I have a pacemaker, defibrillator, or brain stimulator, or significant heart rhythm problems.

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I have been diagnosed with HIV.

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I have an active tuberculosis infection.

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I cannot have an MRI for treatment planning or follow-up.

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My cancer has spread to the brain stem.

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I experience nausea or vomiting due to increased pressure in my brain.

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I am currently being treated for an infection.

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I have not received a live vaccine in the last 30 days.

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I have a decreased level of alertness due to increased pressure in my brain.

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I have had pneumonitis treated with steroids but am currently on 20 mg or less of prednisone.

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I have been diagnosed with severe swelling of the optic nerve.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from srs to death, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from srs to death, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from srs to death, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The percentage of patients developing grade 3 CNS toxicity

Secondary study objectives

Intracranial control

Overall survival (OS)

Progression free survival (PFS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (nivolumab, ipilimumab, SRS, TTFields)Experimental Treatment4 Interventions

Patients receive standard of care nivolumab and ipilimumab and undergo 3-5 fractions SRS. Patients also undergo TTFields over 8 hours daily using NovoTTF-100M device until intra-cranial progression or until end of immunotherapy treatments at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (SRS, pembrolizumab, TTFields)Experimental Treatment3 Interventions

Patients receive standard of care pembrolizumab and undergo 3-5 fractions SRS. Patients also undergo TTFields over 8 hours daily using NovoTTF-100M device until intra-cranial progression or until end of immunotherapy treatments at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Pembrolizumab

2017

Completed Phase 3

~3150