CD8+ PET Companion Trial
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|ClinicalTrials.gov Identifier: NCT05279027|
Recruitment Status : Enrolling by invitation
First Posted : March 15, 2022
Last Update Posted : June 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: 89Zr-Df-IAB22M2C PET/CT||Early Phase 1|
This is a single institution, prospective cohort study of 89Zr-Df-IAB22M2C 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 89Zr-Df-IAB22M2C 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 Baseline 89Zr-Df-IAB22M2C PET/CT scan prior to starting immunotherapy + HCQ therapy. For the Baseline study, subjects will be injected with 89Zr-Df-IAB22M2C 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 89Zr-Df-IAB22M2C PET/CT scan at day 12 (± 2 days) post therapy, which will require administration of 89Zr-Df-IAB22M2C on the day prior to the scan. 89Zr-Df-IAB22M2C PET/CT scans will be acquired with an interval of ≥ 12 days between scans, to ensure that the signal from the previous injection of 89Zr-Df-IAB22M2C has decayed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||89Zr-Df-IAB22M2C (Anti-CD8 Minibody) PET/CT Imaging as a Measure of Response in Patients With Advanced Melanoma on Immunotherapy Plus Hydroxychloroquine.|
|Actual Study Start Date :||March 8, 2022|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||February 28, 2025|
Experimental: PET imaging
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: 89Zr-Df-IAB22M2C PET/CT
89Zr-Df-IAB22M2C PET/CT scans pre and post therapy initiation
- 89Zr-Df-IAB22M2C uptake [ Time Frame: 21 days ]89Zr-Df-IAB22M2C measured uptake *(by standard uptake value) on Baseline and post-Treatment PET/CT scans in tumor lesions and lymphoid organs.
- Change in uptake post therapy [ Time Frame: 21 days ]Measurement of change in 89Zr-Df-IAB22M2C uptake between Baseline and post-Treatment PET/CT scans in tumor lesions and lymphoid organs.
- Post therapy outcomes [ Time Frame: until the end of the study, usually about 3 years ]Association between change in tumor 89Zr-Df-IAB22M2C uptake and objective response, progression free survival, and overall survival.
- CD8+ TIL density in tumor [ Time Frame: 2 months ]Association between tumor 89Zr-Df-IAB22M2C uptake and CD8+ TIL density in biopsied tumors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05279027
|United States, Pennsylvania|
|Perleman Center for Advanced Medicine|
|Philadelphia, Pennsylvania, United States, 19104|