ImmunoPET With an Anti-CD8 Imaging Agent | NCT04029181

NCT04029181

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose finding cohort	Experimental	In part A of this imaging trial, a dose finding study will be performed to establish safety, to assess the appropriate protein dose for PET-scanning and to assess the appropriate PET scanning interval.	Other: Anti-CD8 PET imaging agent
Feasibility cohort	Experimental	The purpose of part B of the study is to analyze the PK of the anti-CD8 imaging agent in patients before and during treatment with checkpoint inhibitors.	Other: Anti-CD8 PET imaging agent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-CD8 PET imaging agent	Other	An imaging agent radiolabelled with 89Zr developed for in human PET imaging of CD8	Dose finding cohort Feasibility cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events related to tracer administration as assessed by CTCAE v4.0	Safety assessment through summaries of adverse events, changes in laboratory test results (if evaluation is indicated), changes in vital signs, and exposure to ZED88082A/CED88004S. Adverse event data will be recorded and summarized according to NCI CTCAE v4.0.	2 years
Appropriate dosing of anti-CD8 imaging agent and PET imaging time points	Appropriate dosing and imaging time points of the anti-CD8 imaging agent will be determined based on measurements of standardized uptake value (SUV) of defined volumes of interest (VOIs) on the immunoPET scan images	2 years
Pharmacokinetics (PK) of anti-CD8 imaging agent	Description of PK of the anti-CD8 imaging agent by measuring standardized uptake value (SUV) on PET scans performed 0, 2, 4 and/or 7 days after tracer injection before and during MPDL3280A or PD-1 antibody immune checkpoint inhibitor plus or minus ipilimumab treatment.	2 years
Immunogenic potential of the anti-CD8 imaging agent by measuring incidence of anti-drug antibodies	Assessment of the immunogenic potential of the anti-CD8 imaging agent by measuring incidence of anti-drug antibodies during the study relative to the prevalence of ADAs at baseline and assessing their relationship to other outcomes measured.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Heterogeneity of tumor uptake of the anti-CD8 imaging agent	Heterogeneity of imaging tracer uptake will be evaluated by measuring standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the immunoPETscan images	2 years
Correlation of normal organ uptake of the anti-CD8 imaging agent to (serious) adverse events (possibly) related to immune checkpoint inhibitor treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Name	Affiliation	Role
E. G.E. de Vries, MD, PhD	University Medical Center Groningen	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36471036	Derived	Kist de Ruijter L, van de Donk PP, Hooiveld-Noeken JS, Giesen D, Elias SG, Lub-de Hooge MN, Oosting SF, Jalving M, Timens W, Brouwers AH, Kwee TC, Gietema JA, Fehrmann RSN, Fine BM, Sanabria Bohorquez SM, Yadav M, Koeppen H, Jing J, Guelman S, Lin MT, Mamounas MJ, Eastham JR, Kimes PK, Williams SP, Ungewickell A, de Groot DJA, de Vries EGE. Whole-body CD8+ T cell visualization before and during cancer immunotherapy: a phase 1/2 trial. Nat Med. 2022 Dec;28(12):2601-2610. doi: 10.1038/s41591-022-02084-8. Epub 2022 Dec 5.
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ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms