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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights
RadVax Trial 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.
RadVax Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
RadVax Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
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
RadVax 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
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,612 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
105,012 Total Patients Enrolled
16 Trials studying Melanoma
872 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,802 Total Patients Enrolled
557 Trials studying Melanoma
193,138 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any autoimmune diseases except for stable thyroid issues, vitiligo, alopecia, Grave's disease, or psoriasis not needing strong treatment in the past year.I have a tumor between 1cm and 7cm suitable for high-focus radiation therapy.Your hemoglobin level is at least 9 grams per deciliter.I am not currently receiving any cancer treatments like chemotherapy or immunotherapy.I haven't had cancer treatment in the last 2 weeks or have recovered from its side effects.I haven't had major surgery or am still recovering from one within the last 28 days.I haven't taken strong immune-suppressing drugs in the last 14 days, except for minor exceptions.I have not received a live vaccine in the last 28 days.I cannot have certain types of radiation due to my existing conditions.I am not pregnant, breastfeeding, nor plan to become pregnant during the study.I agree to use or have my partner use effective birth control or abstain from sex.You are allergic to nivolumab, ipilimumab, or similar medications.You have tested positive for HIV, Hepatitis B, or Hepatitis C.Your bilirubin levels in the blood should not be too high.You must have at least 2,500 white blood cells per microliter of blood.You have enough white blood cells called neutrophils.I do not have any severe illnesses that could interfere with the study.I am using or willing to use two birth control methods or I am not able to have children.My organ functions are within normal ranges as per recent tests.My kidney function, measured by creatinine or GFR, is within the normal range.I do not need immediate treatment for brain metastases and do not have carcinomatous meningitis.I have no active cancer except for certain skin, cervical, or breast conditions.You need to have at least 100,000 platelets per microliter of blood.I have previously been treated with specific immune-targeting drugs, but not CTLA-4 blockers.My melanoma has been confirmed to have spread through testing.I am over 18 and can sign the consent form.I have recovered from previous cancer treatment side effects, except for hair loss or conditions that won't worsen.I have at least two tumors that can be measured.I am fully active or can carry out light work.I haven't had radiotherapy that would interfere with the new treatment in the last 28 days.Your liver enzymes (AST and ALT) are not more than 2.5 times the upper limit of normal. If you have liver metastases, they should not be more than 5 times the upper limit of normal.I can lie flat and stay still for my treatment.I have had primary immunodeficiency or tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: No HFRT
- Group 2: HFRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Ipilimumab been officially recognized by the FDA?
"With limited efficacy data, ipilimumab scores a 2 in terms of safety. This ranking is reflective of the fact that it is currently undergoing Phase 2 clinical trials."
Answered by AI
To what ailments is Ipilimumab typically applied as a treatment?
"Ipilimumab is often the first line of defense against anti-angiogenic therapy, but it can also be beneficial in treating malignant neoplasms, uncontrollable melanoma, and squamous cell carcinoma."
Answered by AI
To what extent has Ipilimumab been investigated in past clinical experiments?
"Currently, 765 studies are running investigating Ipilimumab's efficacy. Of those active clinical trials, 86 have entered Phase 3 testing. These investigations into the treatment occur in 42755 locations throughout the USA and primarily center around Pittsburgh, Pennsylvania."
Answered by AI
Does the research team need additional participants for their experiment?
"According to the information stored on clinicaltrials.gov, this trial is open for recruitment and has been since August 23rd 2018. The entry was last updated on March 30th 2022."
Answered by AI
How many participants has this clinical experiment attracted?
"Affirmative. According to clinicaltrials.gov, this examination is currently in the process of enlisting volunteers which began on August 23 2018 and has been updated lastly at March 30 2022. Specifically, 52 patients are required across 2 sites for successful completion of the trial."
Answered by AI
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