Status:
ACTIVE_NOT_RECRUITING
ImmunoPET With an Anti-CD8 Imaging Agent
Lead Sponsor:
University Medical Center Groningen
Conditions:
Metastatic Cancer
Unresectable Malignant Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single-center, single-arm, investigator sponsored trial designed to evaluate the PK of the anti-CD8 imaging agent in patients prior to and during treatment with checkpoint inhibitors.
Eligibility Criteria
Inclusion
- Subjects with histologically confirmed locally advanced or metastatic cancer for the following tumor types
- Cancer types other than melanoma; subjects meeting the eligibility criteria as formulated in the MPDL3280A treatment study protocol (MPDL3280A-treatment-IST-UMCG) are eligible for part A or part B1.
- Melanoma; subjects eligible to receive standard of care anti-PD1 therapy plus or minus ipilimumab, are eligible for part B2.
- Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
- Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions.
- Signed informed consent.
- Age ≥18 at the time of signing informed consent.
- Life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Ability to comply with the protocol.
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate \[\< 1% per year\] when used consistently and correctly).
Exclusion
- Potential subjects with cancer other than melanoma will be excluded from participation in this study if they meet exclusion criteria formulated in the MPDL3280A treatment study protocol (MPDL3280A-treatment-IST-UMCG).
- Signs or symptoms of infection within 2 weeks prior to anti-CD8 imaging agent injection.
- Prior immune checkpoint inhibitor treatment, including but not limited to anti-PD1 and anti-PD-L1 therapeutic antibodies.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the anti-CD8 imaging agent, or that may affect the interpretation of the results or render the patient at high risk from complications.
- Pregnant or lactating women.
Key Trial Info
Start Date :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04029181
Start Date
February 14 2019
End Date
December 1 2024
Last Update
May 3 2024
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands