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Pembrolizumab-PET Imaging

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Prof.dr. E.G.E. de Vries, University Medical Center Groningen
Sponsor:
Information provided by (Responsible Party):
Prof.dr. E.G.E. de Vries, University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT02760225
First received: March 29, 2016
Last updated: January 17, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Melanoma Non-small Cell Lung Cancer Drug: 89Zr-Pembrolizumab Device: 89Zr-Pembrolizumab PET

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 89Zr-pembrolizumab-PET Imaging in Patients With Locally Advanced or Metastatic Melanoma or Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Prof.dr. E.G.E. de Vries, University Medical Center Groningen:

Primary Outcome Measures:
  • Description of whole body 89Zr-pembrolizumab by measuring standardized uptake value (SUV) on the 89Zr-pembrolizumab-PET scans [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 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. [ Time Frame: 1 year ]
    Safety assessment through summaries of adverse events, changes in laboratory test results (if evaluation is indicated), changes in vital signs, and exposure to 89Zr-pembrolizumab. Adverse event data will be recorded and summarized according to NCI CTCAE v4.0. Serious adverse events, including deaths, will be listed separately and will be summarized. For events of varying severity, the highest grade will be used in summaries. Relevant laboratory tests and vital signs (heart rate, respiratory rate, blood pressures, and temperature) data will be displayed by time, with Grade 3 and 4 values identified, where appropriate.

  • 89Zr-pembrolizumab normal organ uptake on the 89Zr-pembrolizumab PET scans will be correlated to (89Zr-)pembrolizumab blood kinetics. [ Time Frame: 1 year ]
    89Zr-pembrolizumab normal organ uptake on the 89Zr-pembrolizumab PET scans will be correlated to (89Zr-)pembrolizumab blood kinetics. Aliquots of whole blood and serum will be measured for 89Zr-activity in an isotope well counter and corrected for decay. Whole blood and serum activity will be expressed as standardized uptake value (SUV). Serum blood samples will also be collected regularly during the study to measure unlabeled pembrolizumab. PK parameters will be derived from the serum concentrations.

  • Evaluation of ORR according to standard RECIST v1,1 [ Time Frame: 1 year ]
    Evaluation of ORR according to standard RECIST v1,1. ORR is defined as the proportion of subjects whose best overall response is either a PR or CR.


Estimated Enrollment: 21
Study Start Date: September 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 89Zr-Pembrolizumab PET imaging
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
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.
Other Name: Injection of 89Zr-Pembrolizumab for imaging
Device: 89Zr-Pembrolizumab PET
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.
Other Name: 89Zr-Pembrolizumab PET scan(s)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years.
  2. Histologically or cytologically documented locally advanced or metastatic melanoma or NSCLC.
  3. 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.
  4. Metastatic lesion(s) (≥1,0 cm) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  6. Life expectancy ≥ 12 weeks .
  7. Signed Informed Consent Form.
  8. Ability to comply with protocol.
  9. Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions.
  10. 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.
    • Asparate Aminotransferase (AST), Alanine Aminotransferase (ALT), and alkaline phosphatase ≤2.5 x the Upper Limit of Normal (ULN), with the following exceptions:

      • Patients with documented liver metastases: AST and/or ALT ≤ 5 x ULN
      • Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 x ULN
    • Serum bilirubin ≤ 1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level ≤3 x ULN may be enrolled.
    • International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (aPTT) ≤1.5 x ULN. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
    • Creatinine clearance ≥30 mL/min
  11. 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:

  1. 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.

  2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the 89Zr-pembrolizumab injection.
  3. 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).
  4. Pregnant and lactating women.
  5. Symptomatic brain metastasis.
  6. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  7. Known hypersensitivity or allergy to any component of the pembrolizumab formulation.
  8. 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.
  9. Positive test for Human Immunodeficiency Virus (HIV).
  10. 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.
  11. Signs or symptoms of infection within 2 weeks prior to 89Zr-pembrolizumab injection.
  12. Major surgical procedure other than for diagnosis within 28 days prior to 89Zr-pembrolizumab injection or anticipation of need for a major surgical procedure during the course of the study.
  13. Prior allogeneic bone marrow transplantation or solid organ transplant.
  14. Treatment with corticosteroids in an increasing dosage in the 7 days prior to 89Zr-pembrolizumab injection. (A stable or decreasing dosage of ≤ 1,5 mg dexamethasone or ≤ 10 mg prednisolone equivalent is allowed. In addition, inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease.)
  15. Inability to comply with other requirements of the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02760225

Contacts
Contact: E. G.E. de Vries, Prof. +31 50 3612821 e.g.e.de.vries@umcg.nl
Contact: I.C. Kok, MD +31 50 3616161 i.c.kok@umcg.nl

Locations
Netherlands
Netherlands Cancer Institute Not yet recruiting
Amsterdam, Netherlands
Contact: J. Haanen, Prof.       j.haanen@nki.nl   
Principal Investigator: J. Haanen, Prof         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: E. G.E. de Vries, Prof.    +31 50 3612821    e.g.e.de.vries@umcg.nl   
Contact: I.C. Kok, MD    +31 50 3616161    i.c.kok@umcg.nl   
Principal Investigator: E. G.E. de Vries, Prof.         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: E. G.E. de Vries, Prof. Universit Medical Center Groningen
  More Information

Responsible Party: Prof.dr. E.G.E. de Vries, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02760225     History of Changes
Other Study ID Numbers: 201600163
Study First Received: March 29, 2016
Last Updated: January 17, 2017

Keywords provided by Prof.dr. E.G.E. de Vries, University Medical Center Groningen:
Pembrolizumab
PET imaging
Melanoma
Non-small cell lung cancer

Additional relevant MeSH terms:
Pembrolizumab
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 26, 2017