ImmunoPET imaging with 89Zr-MPDL3280A in patients with locally advanced or metastatic solid tumors prior to and during MPDL3280A treatment

Completed

Conditions: cancer
solid tumors
10027655

Registration Number: NL-OMON47805

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 54

Inclusion Criteria

1.Histologically or cytologically documented locally advanced or metastatic solid tumor whom, in the opinion of the investigator, based on available clinical data, may benefit from treatment with anti PD-L1 immunotherapy.
2.Patients are eligible if disease progression during or following first-line systemic therapy or any subsequent treatment lines for locally advanced or metastatic solid tumor whom, in the opinion of the investigator, based on available clinical data, may benefit from treatment with anti PD-L1 immunotherapy
* Additional criteria for cancer of the urinary tract : Patients with disease progression during or following platinum-based adjuvant/neoadjuvant chemotherapy are eligible if * 12 months have elapsed between the last treatment administration and the date of recurrence.
*Additional criteria for NSCLC: Patients with disease progression during or following platinum-based adjuvant/neoadjuvant chemotherapy or concurrent chemoradiation for NSCLC are eligible if * 6 months have relapsed between the last treatment administration and the date of recurrence.
3.Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
4.ECOG performance status of 0 or 1.
5.Life expectancy *12 weeks.
6.Signed Informed Consent Form.
7.Ability to comply with protocol.
8.Age *18 years.
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-MPDL3280A injection:
*ANC *1500 cells/*L (without granulocyte colony-stimulating factor support within 2 weeks prior to 89Zr-MPDL3280A injection)
*WBC counts >2500/*L
*Lymphocyte count *500/*L
*Platelet count *100,000/*L (without transfusion within 2 weeks prior to 89Zr-MPDL3280A injection)
*Hemoglobin *9.0 g/dL. Patients may be transfused or receive erythropoietic treatment to meet this criterion.
*AST, ALT, and alkaline phosphatase * 2.5× the upper limit of normal (ULN), with the following exceptions:
Patients with documented liver metastases: AST and/or ALT * 5 × ULN; Patients with documented liver or bone metastases: alkaline phosphatase * 5 × ULN
*Serum bilirubin * 1.5 × ULN. Patients with known Gilbert disease who have serum bilirubin level * 3 × ULN may be enrolled.
*INR and aPTT * 1.5 × 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 or hormonal therapy within *14 days prior to 89Zr- MPDL3280A injection; the following exceptions are allowed: *Hormone-replacement therapy or oral contraceptives *TKIs approved for treatment of NSCLC discontinued >7 days prior to tracer injection. The baseline scan must be obtained after discontinuation of prior TKIs. 2.Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the 89Zr-MPDL3280A injection.
3.Unstable brain metastases.
4.Unstable leptomeningeal disease.
5.Uncontrolled tumor-related pain.
*Patients requiring pain medication must be on a stable regimen at study entry. *Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period. *Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
6.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.
7.Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or calcium >12 mg/dL or corrected serum calcium >ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab. *Patients, who are receiving bisphosphonate therapy or denosumab
specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible.
8.A second malignancy within 5 years prior to 89Zr-MPDL3280A 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, ductal carcinoma in situ treated surgically with curative intent).
9.Pregnant and lactating women.
10.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
11.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cell products or any component of the MPDL3280A formulation.
12.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.
* Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitt

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Description of 89Zr-MPDL3280A PK by measuring standardized uptake value (SUV)<br /><br>on the 89Zr-MPDL3280A-PET scans 0, 2, 4 and/or 7 days after tracer injection.</p><br>

Secondary Outcome Measures