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Monoclonal Antibodies
Zr89 Imaging for Melanoma
Phase < 1
Waitlist Available
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least one site of measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT
History of histologically confirmed melanoma as assessed per medical record review
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until the end of the study, usually about 3 years
Awards & highlights
Study Summary
This trial is testing a new way to image melanoma in order to better assess an early response to therapy. Patients with melanoma who are eligible for the trial and have at least one site of measurable disease will be potentially eligible.
Who is the study for?
Adults with advanced melanoma who are eligible for the LIMIT Melanoma Trial, have at least one measurable disease site, and proper organ function. Pregnant or breastfeeding women, those unable to tolerate imaging procedures, with serious medical conditions, ineligible for the LIMIT trial or with splenic disorders are excluded.Check my eligibility
What is being tested?
The study tests Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT as a marker for early response in melanoma patients receiving immunotherapy and hydroxychloroquine. It aims to correlate imaging results with progression-free survival (PFS) and overall survival (OS).See study design
What are the potential side effects?
While specific side effects of Zirconium Zr 89 Crefmirlimab Berdoxa aren't listed here, PET/CT scans may cause discomfort or reactions related to tracer injection; consult your doctor about potential risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one tumor that can be measured on scans.
Select...
My melanoma diagnosis has been confirmed by a tissue examination.
Select...
My blood, liver, and kidney functions meet the trial's required levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until the end of the study, usually about 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until the end of the study, usually about 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in uptake post therapy
Zirconium Zr 89 Crefmirlimab Berdoxa uptake
Secondary outcome measures
CD8+ TIL density in tumor
Post therapy outcomes
Trial Design
1Treatment groups
Experimental Treatment
Group I: PET imagingExperimental Treatment1 Intervention
This is a single institution, prospective cohort study of 89Zr-Df-IAB22M2C PET/CT as an early measure of response in patients with melanoma.
Find a Location
Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,075 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,675 Total Patients Enrolled
ImaginAb, Inc.Industry Sponsor
12 Previous Clinical Trials
280 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well enough for the LIMIT Melanoma Trial.I have at least one tumor that can be measured on scans.I have a spleen condition or had my spleen removed that may affect the study.I am not pregnant or breastfeeding.My melanoma diagnosis has been confirmed by a tissue examination.My blood, liver, and kidney functions meet the trial's required levels.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: PET imaging
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.
Is this research study still recruiting new participants?
"This study is not actively recruiting patients at this time, according to the clinicaltrials.gov website. The trial was first posted on March 8th, 2022 and was last updated on May 31st, 2022. Although this specific study is not looking for candidates right now, there are 789 other trials that are currently open and accepting participants."
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