Zr89 Imaging for Melanoma

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Must be taking: Immunotherapy, Hydroxychloroquine

Disqualifiers: Pregnancy, Splenic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study involves patients already on immunotherapy and hydroxychloroquine, it seems likely you can continue these treatments.

Eligibility Criteria

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.

Inclusion Criteria

My organs are functioning well enough for the LIMIT Melanoma Trial.

I have at least one tumor that can be measured on scans.

My melanoma diagnosis has been confirmed by a tissue examination.

Exclusion Criteria

Ineligible for the LIMIT Melanoma Trial

I have a spleen condition or had my spleen removed that may affect the study.

Inability to tolerate imaging procedures in the opinion of the investigator or treating physician

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Imaging

Participants undergo a Baseline Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scan prior to starting therapy

1 week

1 visit (in-person)

Treatment Imaging

Participants undergo a Post-Treatment Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT scan at day 14 post therapy

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• Crefmirlimab Berdoxa
• Zirconium Zr 89 Crefmirlimab Berdoxa

Trial Overview 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).

Participant Groups

Group I: PET imaging Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

ImaginAb, Inc.

Industry Sponsor

Trials

13

Recruited

280+