An Early Phase 1 interventional study of Zirconium Zr 89 Crefmirlimab Berdoxa in Melanoma (Skin), sponsored by Abramson Cancer Center at Penn Medicine. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Abramson Cancer Center at Penn Medicine · Early Phase 1, Interventional, and Diagnostic
Study of Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT as an imaging biomarker for assessing an early response to therapy in patients with advanced melanoma on immunotherapy and hydroxychloroquine. This study is a companion study to the "LIMIT Melanoma Trial." Patients with melanoma who are potentially eligible for the LIMIT Melanoma Trial and have at least one site of measurable disease based on RECIST 1.1 are potentially eligible. Associations with progression-free survival (PFS) and overall survival (OS) will be tested.
This is a single institution, prospective cohort study of Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT as an early measure of response in patients with melanoma. This study is a companion imaging study to the "LIMIT Melanoma Trial". Patients with melanoma who are candidates for the LIMIT Melanoma treatment trial and are at least 18 years of age may be eligible. All participants will be receiving care at the clinical practices of the University of Pennsylvania. Patients will be approached about study participation regardless of race or ethnic background. We anticipate enrolling up to 20 evaluable participants with melanoma who meet eligibility requirements for this study. An evaluable patient has completed Baseline and at the post-Treatment Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scans. Accrual is estimated to occur over approximately 3 years.
After undergoing screening assessments and verifying eligibility for study participation subjects will be scheduled to undergo a BaselineZirconium Zr 89 Crefmirlimab Berdoxa PET/CT scan prior to starting immunotherapy + HCQ therapy. For the Baseline study, subjects will be injected with Zirconium Zr 89 Crefmirlimab Berdoxa up to 8 days prior to starting therapy (Day -8 to 0), and will undergo PET/CT imaging 24 ± 4 hours post injection, and prior to therapy administration. Subjects will then undergo a Post-Treatment Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scan at day 14 (± 4 days) post therapy, which will require administration of Zirconium Zr 89 Crefmirlimab Berdoxa on the day prior to the scan. Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scans will be acquired with an interval of ≥ 10 days between scans, to ensure that the signal from the previous injection of Zirconium Zr 89 Crefmirlimab Berdoxa has decayed.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 6 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must have adequate baseline organ function as determined per LIMIT Melanoma Trial (IRB 835033) (these tests will be completed as part of LIMIT trial screening and will not be repeated for the imaging companion study)
Adequate organ function: per LIMIT Melanoma Trial (IRB 35033)
System Laboratory Values Hematologic Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L Hemoglobin ≥ 9 g/dL Platelet Count ≥ 100 x 109/L PT/INRa and PTT ≤ 1.3 x ULN Hepatic Total Bilirubinb ≤ 1.5 x ULN AST and ALT ≤ 2.5 x ULN Renal Serum Creatinine ≤ 1.5 mg/dL Abbreviations: ALT = alanine transaminase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; INR = international normalized ratio; LLN = lower limit of normal; PT = prothrombin time; PTT = partial thromboplastin time; ULN = upper limit of normal.
a Subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to enrollment.
b Subjects with known Gilbert's syndrome must have a total bilirubin \< 3.0 x ULN).
c If serum creatinine is > 1.5 mg/dL, calculate creatinine clearance using standard Cockcroft-Gault formula. Creatinine clearance must be ≥ 50 mL/min to be eligible.
Exclusion Criteria:
This is a single institution, prospective cohort study of 89Zr-Df-IAB22M2C PET/CT as an early measure of response in patients with melanoma.
Drug: Zirconium Zr 89 Crefmirlimab Berdoxa
Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scans pre and post therapy initiation
Zirconium Zr 89 Crefmirlimab Berdoxa uptake
Zirconium Zr 89 Crefmirlimab Berdoxa measured uptake \*(by standard uptake value) on Baseline and post-Treatment PET/CT scans in tumor lesions and lymphoid organs.
Time frame: 21 days
Change in uptake post therapy
Measurement of change in Zirconium Zr 89 Crefmirlimab Berdoxa uptake between Baseline and post-Treatment PET/CT scans in tumor lesions and lymphoid organs.
Time frame: 21 days
Post therapy outcomes
Association between change in tumor Zirconium Zr 89 Crefmirlimab Berdoxa uptake and objective response, progression free survival, and overall survival.
Time frame: until the end of the study, usually about 3 years
CD8+ TIL density in tumor
Association between tumor Zirconium Zr 89 Crefmirlimab Berdoxa uptake and CD8+ TIL density in biopsied tumors.
Time frame: 2 months
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine