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Checkpoint Inhibitor

Immunotherapy + Radiation for Metastatic Melanoma (RadVax Trial)

Phase 2

Recruiting

Led By Tara Mitchell, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

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

Must have

Histologically confirmed metastatic melanoma

Have at least two measurable lesions (including the index lesion) according to RECIST guidelines v1.1

Must not have

Concurrent treatment with any anticancer agent, including chemotherapy, immunotherapy, or biologic therapy

Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of nivolumab/ipilimumab or still recovering from prior surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years

Awards & highlights

Summary

This trial will study the safety of adding radiation to immunotherapy for metastatic melanoma. It will also compare the effectiveness of this combo treatment to immunotherapy alone.

Who is the study for?

Adults over 18 with metastatic melanoma, not pregnant or breastfeeding, willing to use birth control. They must have good organ function and an index lesion suitable for radiotherapy. Excluded are those with certain autoimmune diseases, brain metastases needing urgent treatment, prior T-cell targeting therapy, recent other cancer treatments or surgeries.Check my eligibility

What is being tested?

The trial is testing the combination of two immunotherapy drugs (Ipilimumab and Nivolumab) with hypofractionated radiotherapy on a single tumor versus just the drugs alone in patients with metastatic melanoma to assess safety and impact on the cancer.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, fatigue, skin issues like rash or itching, gastrointestinal problems such as diarrhea or colitis, liver inflammation indicated by elevated enzymes and hormone gland problems leading to changes in hormone levels.

Eligibility Criteria

Inclusion Criteria

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

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My melanoma has been confirmed to have spread through testing.

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I have at least two tumors that can be measured.

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I am over 18 and can sign the consent form.

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I am fully active or can carry out light work.

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My kidney function, measured by creatinine or GFR, is within the normal range.

Exclusion Criteria

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

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I am not currently receiving any cancer treatments like chemotherapy or immunotherapy.

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I haven't had major surgery or am still recovering from one within the last 28 days.

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I am not pregnant, breastfeeding, nor plan to become pregnant during the study.

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I do not need immediate treatment for brain metastases and do not have carcinomatous meningitis.

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I have previously been treated with specific immune-targeting drugs, but not CTLA-4 blockers.

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I do not have any severe illnesses that could interfere with the study.

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I haven't had radiotherapy that would interfere with the new treatment in the last 28 days.

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I have had primary immunodeficiency or tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 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

Number of Adverse Events

Secondary outcome measures

progression-free survival

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HFRTExperimental Treatment3 Interventions

The dose of hypofractionated radiation therapy (HFRT) will be 8 Gy x 3 fractions, given over a maximum of 7 days timespan.

Group II: No HFRTActive Control2 Interventions

ipilimumab and nivolumab once every 3 weeks for up to 4 doses, followed by nivolumab once every 2 weeks or every 4 weeks until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4740

Ipilimumab

2014

Completed Phase 3

~2610

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

396 Previous Clinical Trials

147,914 Total Patients Enrolled

17 Trials studying Melanoma

897 Patients Enrolled for Melanoma

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

105,869 Total Patients Enrolled

16 Trials studying Melanoma

872 Patients Enrolled for Melanoma

National Cancer Institute (NCI)NIH

13,748 Previous Clinical Trials

40,959,349 Total Patients Enrolled

559 Trials studying Melanoma

195,390 Patients Enrolled for Melanoma

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03646617 — Phase 2

Melanoma Research Study Groups: HFRT, No HFRT

Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03646617 — Phase 2

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03646617 — Phase 2

~8 spots leftby Jul 2025

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