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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
Have an index lesion measuring between 1cm - 7cm that is amenable to HFRT radiation therapy at the discretion of the treating radiation oncologist
Non-sterilized male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Acceptable forms of birth control include condoms, diaphragms, cervical cap, an intra-uterine device (IUD), surgical sterility (tubal ligation or a partner that has undergone a vasectomy), or oral contraceptives, OR the subject must agree to completely abstain from heterosexual intercourse. Abstinence at certain times of the cycle only, such as during the days of ovulation, after ovulation and withdrawal are not acceptable methods of birth control
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 below
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I have a tumor between 1cm and 7cm suitable for high-focus radiation therapy.
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I agree to use or have my partner use effective birth control or abstain from sex.
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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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I have recovered from previous cancer treatment side effects, except for hair loss or conditions that won't worsen.
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I am using or willing to use two birth control methods or I am not able to have children.
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My organ functions are within normal ranges as per recent tests.
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My kidney function, measured by creatinine or GFR, is within the normal range.
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I can lie flat and stay still for my treatment.

RadVax Trial Timeline

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

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
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,643 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
105,043 Total Patients Enrolled
16 Trials studying Melanoma
872 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,101 Total Patients Enrolled
557 Trials studying Melanoma
193,181 Patients Enrolled for Melanoma

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03646617 — Phase 2
Melanoma Research Study Groups: No HFRT, 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

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
~2 spots leftby Jun 2024