Pembrolizumab-PET Imaging

NCT02760225 | Completed

• 1 other identifier: 201600163
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

This is a two center, single arm, investigator sponsored trial (IST) with the PET tracer 89Zr-pembrolizumab to evaluate in vivo whole body distribution of 89Zr-Pembrolizumab in a registered indication: locally advanced metastatic melanoma or non-small cell lung cancer before Pembrolizumab treatment.

Conditions

Melanoma; Non-small Cell Lung Cancer

Keywords

Pembrolizumab; PET imaging; Melanoma; Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Description of whole body 89Zr-pembrolizumab by measuring standardized uptake value (SUV) on the 89Zr-pembrolizumab-PET scans

  1 year

Secondary Outcomes (4)

• Tumor and immune cell PD-L1 expression analysis in a fresh pre-treatment biopsy, and if available archival tumor biopsy, will be correlated to 89Zr-pembrolizumab tumor uptake, evaluated by measuring SUV on the 89Zr-pembrolizumab-PET.

  1 year

• Safety assessment through summaries of adverse events, changes in laboratory test results, changes in vital signs, and exposure to 89Zr-pembrolizumab. Adverse event data will be recorded and summarized according to NCI CTCAE v4.0.

  1 year

• 89Zr-pembrolizumab normal organ uptake on the 89Zr-pembrolizumab PET scans will be correlated to (89Zr-)pembrolizumab blood kinetics.

  1 year

• Evaluation of ORR according to standard RECIST v1,1

  1 year

Study Arms (1)

89Zr-Pembrolizumab PET imaging

EXPERIMENTAL

In part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A.

Drug: 89Zr-Pembrolizumab; Device: 89Zr-Pembrolizumab PET

Interventions

89Zr-Pembrolizumab DRUG

In part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A.

Also known as: Injection of 89Zr-Pembrolizumab for imaging

89Zr-Pembrolizumab PET imaging

89Zr-Pembrolizumab PET DEVICE

In part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A.

Also known as: 89Zr-Pembrolizumab PET scan(s)

89Zr-Pembrolizumab PET imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Histologically or cytologically documented locally advanced or metastatic melanoma or NSCLC.
• Patients must be eligible for treatment with Pembrolizumab. For patients with NSCLC this includes PD-L1 expression (\>1% based on IHC assay) on tumor material.
• Metastatic lesion(s) (≥1,0 cm) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Life expectancy ≥ 12 weeks .
• Signed Informed Consent Form.
• Ability to comply with protocol.
• Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions.
• Adequate hematologic and end organ function, defined by the following laboratory results obtained within ≤ 14 days prior to 89Zr-pembrolizumab injection:
• Absolute Neutrophil Count (ANC) ≥ 1500 cells/μL (without granulocyte colony-stimulating factor support within 2 weeks prior to 89Zr-pembrolizumab injection)
• White Blood Count (WBC) ≥ 2500/μL
• Lymphocyte count ≥ 500/μL
• Platelet count ≥ 100,000/μL (without transfusion within 2 weeks prior to 89Zr-Pembrolizumab injection)
• Hemoglobin ≥9.0 g/dL. Patients may be transfused or receive erythropoietin treatment to meet this criteria.

You may not qualify if:

• Any approved anti-cancer therapy, including chemotherapy of hormonal therapy within ≤14 days prior to 89Zr-pembrolizumab injection; the following exceptions are allowed:
• Hormone-replacement therapy or oral contraceptives.
• Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the 89Zr-pembrolizumab injection.
• Malignancies other than melanoma or NSCLC within 5 years prior to 89Zr-pembrolizumab injection, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent or ductal carcinoma in situ treated surgically with curative intent).
• Pregnant and lactating women.
• Symptomatic brain metastasis.
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
• Known hypersensitivity or allergy to any component of the pembrolizumab formulation.
• History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
• Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
• Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
• Positive test for Human Immunodeficiency Virus (HIV).
• Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \[HBsAg\] test at screening) or hepatitis C.
• Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \[HBcAb\] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to 89Zr-Pembrolizumab injection.
• Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (2)

Netherlands Cancer Institute

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

• Li W, Wang Y, Rubins D, Bennacef I, Holahan M, Haley H, Purcell M, Gantert L, Hseih S, Judo M, Seghezzi W, Zhang S, van der Veen EL, Lub-de Hooge MN, de Vries EGE, Evelhoch JL, Klimas M, Hostetler ED. PET/CT Imaging of 89Zr-N-sucDf-Pembrolizumab in Healthy Cynomolgus Monkeys. Mol Imaging Biol. 2021 Apr;23(2):250-259. doi: 10.1007/s11307-020-01558-w. Epub 2020 Oct 26.

  PMID: 33104972 DERIVED

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• E. G.E. de Vries, Prof.

  Universit Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: May 3, 2016
• Study Start: October 24, 2016
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2020
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

NL (2)