Locally Advanced or Metastatic Solid Tumors Irrespective of PD-L1 ExpressionNCT02453984
MPDL3280A-imaging-IST-UMCG
A study testing 89Zr-MPDL-3280A-PET scans in people with Locally Advanced or Metastatic Solid Tumors Irrespective of PD-L1 Expression, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
By performing a 89Zr-MPDL3280A-PET scan prior or during treatment with MPDL3280A, the uptake of the tracer in the primary and metastatic tumor lesions and normal organ distribution can be evaluated, as well as the use of a 89Zr-MPDL3280A-PET as a complementary tool for patient selection and MPDL3280A- target… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors Irrespective of PD-L1 Expression
- What is being tested?
- 89Zr-MPDL-3280A-PET scans
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Feb 2016to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented locally advanced or metastatic solid tumors whom in the opinion of the investigator, based on available clinical data may benefit from treatment with anti-PD-L1.
- Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
- ECOG performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Signed Informed Consent Form.
- Ability to comply with protocol.
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- Age ≥18 years.
- 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-MPDL3280A injection:
- ANC ≥1500 cells/μL (without granulocyte colony-stimulating factor support within 2 weeks prior to 89Zr-MPDL3280A injection).
- WBC counts >2500/μL.
- Lymphocyte count ≥500/μL.
- Platelet count ≥100,000/μL (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.
- 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).
Who cannot join
- 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.
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the 89Zr-MPDL3280A injection.
- Unstable brain metastases.
- Unstable leptomeningeal disease.
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- 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.
- 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.
- 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.
- 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).
- Pregnant and lactating women.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cell products or any component of the MPDL3280A 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.
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
- Rash must cover less than 10% of body surface area (BSA).
- Disease is well controlled at baseline and only requiring low potency topical steroids.
- No acute exacerbation of underlying condition within the previous 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids).
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- ● History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Serum albumin < 2.5 g/dL.
- Positive test for 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-MPDL3280A injection.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Active tuberculosis.
- Severe infections within 4 weeks prior to 89Zr-MPDL3280A injection, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Signs or symptoms of infection within 2 weeks prior to 89Zr-MPDL3280A injection.
- Received therapeutic oral or IV antibiotics within 2 weeks prior to 89Zr-MPDL3280A injection.
- ● Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible.
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina.
- ● Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
- Major surgical procedure other than for diagnosis within 28 days prior to 89Zr-MPDL3280A injection or anticipation of need for a major surgical procedure during the course of the study.
- Prior allogeneic bone marrow transplantation or solid organ transplant.
- Administration of a live, attenuated vaccine within 4 weeks before 89Zr-MPDL3280A injection or anticipation that such a live attenuated vaccine will be required during the study.
- ● Influenza vaccination should be given during influenza season only (example: approximately October to March in the Northern Hemisphere). Patients must not receive live, attenuated influenza vaccine (e.g. FluMist®) within 4 weeks prior to 89Zr-MPDL3280A injection or at any time during the study treatment or within 5 months after the last dose of MPDL3280A.
- 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 an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
- ● Patients who have had prior anti-CTLA-4 treatment may be enrolled, provided the following requirements are met:
- Minimum of 6 weeks from the last dose of anti-CTLA-4.
- No history of severe immune related adverse effects from anti-CTLA-4 (CTCAE Grade 3 and 4).
- Treatment with systemic immunostimulatory agents (including but not limited to IFNs,IL-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to 89Zr-MPDL3280A injection.
- Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to 89Zr-MPDL3280A injection.
- Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g. a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the sponsor.
- The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g. fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ImmunoPET Imaging With 89Zr-MPDL3280A in Patients With Locally Advanced or Metastatic Solid Tumors Prior to and During MPDL3280A Treatment
By performing a 89Zr-MPDL3280A-PET scan prior or during treatment with MPDL3280A, the uptake of the tracer in the primary and metastatic tumor lesions and normal organ distribution can be evaluated, as well as the use of a 89Zr-MPDL3280A-PET as a complementary tool for patient selection and MPDL3280A- target saturation during treatment.
Read the detailed description
The Programmed cell death protein 1 (PD1)/Programmed death-ligand 1 (PD-L1) axis is an important immune checkpoint for T cell activation that is used by tumors to evade the host immune response. Blocking signaling with the PD-L1 antibody MPDL3280A results in ongoing T cell activity and can induce durable tumor regression across numerous solid tumor types. PD-L1 is not only expressed by tumor cells but also by immune cells, activated vascular endothelial cells and in immune privileged sites such as the eye. An obstacle to using PD-L1 expression as predictive biomarker might be its potential heterogeneous expression and fast dynamics. For PD1/PD-L1 pathway inhibition PD-L1 tumor surface expression, positive in 40-100% of all melanoma patients and 35-95% of all non-small-cell lung cancer (NSCLC) patients, was proposed as a potential biomarker. In early clinical trials, PD-L1 expression has been associated with response to PD1/PD-L1 inhibition. However, other clinical trials reported response to PD1/PD-L1 checkpoint inhibitors in up to 47% of PD-L1-negative melanomas assessed by a single biopsy. In bladder cancer weak to strong PD-L1 expression has been reported in 30% of the patients, however also response in PD-L1-negative patients has been seen. For triple-negative breast cancer (TNBC) little is known, but early response data are also very promising.
Radio-labeling of MPDL3280A with the positron emission tomography (PET) radionuclide Zirconium-89 (89Zr) enables non-invasive imaging and quantification of PD-L1 distribution in cancer patients. By performing a 89Zr-MPDL3280A-PET scan prior to treatment with MPDL3280A, the uptake of the tracer in the primary and metastatic tumor lesions and normal organ distribution can be evaluated, as well as the use of a 89Zr-MPDL3280A-PET as a complementary tool for patient selection in the future. There is currently no information with regards to tumor saturation or inflammation induced by checkpoint inhibitors. This can be measured with SUV of 89Zr-MPDL3280A PET changes during a therapeutic dosing with MPDL3280A.
- Being tested
- 89Zr-MPDL-3280A-PET scans
- Keywords
- 89Zr-MPLD3280A-PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-MPDL-3280A-PET scansOther
89Zr-MPDL3280A tracer injection and 89Zr-MPDL-3280A-PET scans
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 89Zr-MPDL3280A-PET scan Receives: Other: 89Zr-MPDL-3280A-PET scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of 89Zr-MPDL3280A PK by measuring standardized uptake value (SUV) on the 89Zr-MPDL3280A-PET scans
Measured: 2 years
Secondary outcomes (3)
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-MPDL3280A tumor uptake, evaluated by measuring standardized uptake value (SUV) on the 89Zr-MPDL3280A-PET.
Measured: 2 years
Safety assessment through summaries of adverse events, changes in laboratory test results, changes in vital signs, and exposure to 89Zr-MPDL3280A. Adverse event data will be recorded and summarized according to NCI CTCAE v4.0.
Measured: 2 years
To assess the level of MPDL3280A target saturation during treatment with MPDL3280A
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study start24 Feb 2016
- Primary completion23 Nov 2020
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced or Metastatic Solid Tumors Irrespective of PD-L1 ExpressionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth de Vries, Professor, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453984
- Sponsor's protocol ID
- MPDL3280A-img-042015
- Status last verified
- May 2024
- First submitted
- 21 May 2015
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Hooiveld-Noeken JS, van de Donk PP, Kist de Ruijter L, Kok IC, van Winkel CAJ, Giesen D, Lub-de Hooge MN, Brouwers AH, Oosting SF, Bensch F, Smit LM, Schroder CP, Jalving M, Elias SG, Gietema JA, Deurloo RJ, Williams SP, Ungewickell A, de Groot DA, de Vries EGE. Programmed death ligand 1 (PD-L1) PET/CT imaging to evaluate tumour saturation during atezolizumab treatment. Br J Cancer. 2026 Sep 10. doi: 10.1038/s41416-026-03595-8. Online ahead of print.
PubMed 42722782Bensch F, van der Veen EL, Lub-de Hooge MN, Jorritsma-Smit A, Boellaard R, Kok IC, Oosting SF, Schroder CP, Hiltermann TJN, van der Wekken AJ, Groen HJM, Kwee TC, Elias SG, Gietema JA, Bohorquez SS, de Crespigny A, Williams SP, Mancao C, Brouwers AH, Fine BM, de Vries EGE. 89Zr-atezolizumab imaging as a non-invasive approach to assess clinical response to PD-L1 blockade in cancer. Nat Med. 2018 Dec;24(12):1852-1858. doi: 10.1038/s41591-018-0255-8. Epub 2018 Nov 26.
PubMed 30478423
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmunoPET Imaging With 89Zr-MPDL3280A in Patients With Locally Advanced or Metastatic Solid Tumors Prior to and During MPDL3280A Treatment
- ClinicalTrials.gov ID
- NCT02453984
- Acronym / sponsor ID
- MPDL3280A-img-042015
- Keywords
- 89Zr-MPLD3280A-PET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 24 Feb 2016 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By performing a 89Zr-MPDL3280A-PET scan prior or during treatment with MPDL3280A, the uptake of the tracer in the primary and metastatic tumor lesions and normal organ distribution can be evaluated, as well as the use of a 89Zr-MPDL3280A-PET as a complementary tool for patient selection and MPDL3280A- target saturation during treatment.
Detailed description
The Programmed cell death protein 1 (PD1)/Programmed death-ligand 1 (PD-L1) axis is an important immune checkpoint for T cell activation that is used by tumors to evade the host immune response. Blocking signaling with the PD-L1 antibody MPDL3280A results in ongoing T cell activity and can induce durable tumor regression across numerous solid tumor types. PD-L1 is not only expressed by tumor cells but also by immune cells, activated vascular endothelial cells and in immune privileged sites such as the eye. An obstacle to using PD-L1 expression as predictive biomarker might be its potential heterogeneous expression and fast dynamics. For PD1/PD-L1 pathway inhibition PD-L1 tumor surface expression, positive in 40-100% of all melanoma patients and 35-95% of all non-small-cell lung cancer (NSCLC) patients, was proposed as a potential biomarker. In early clinical trials, PD-L1 expression has been associated with response to PD1/PD-L1 inhibition. However, other clinical trials reported response to PD1/PD-L1 checkpoint inhibitors in up to 47% of PD-L1-negative melanomas assessed by a single biopsy. In bladder cancer weak to strong PD-L1 expression has been reported in 30% of the patients, however also response in PD-L1-negative patients has been seen. For triple-negative breast cancer (TNBC) little is known, but early response data are also very promising.
Radio-labeling of MPDL3280A with the positron emission tomography (PET) radionuclide Zirconium-89 (89Zr) enables non-invasive imaging and quantification of PD-L1 distribution in cancer patients. By performing a 89Zr-MPDL3280A-PET scan prior to treatment with MPDL3280A, the uptake of the tracer in the primary and metastatic tumor lesions and normal organ distribution can be evaluated, as well as the use of a 89Zr-MPDL3280A-PET as a complementary tool for patient selection in the future. There is currently no information with regards to tumor saturation or inflammation induced by checkpoint inhibitors. This can be measured with SUV of 89Zr-MPDL3280A PET changes during a therapeutic dosing with MPDL3280A.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: 89Zr-MPDL-3280A-PET scans89Zr-MPDL3280A-PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically or cytologically documented locally advanced or metastatic solid tumors whom in the opinion of the investigator, based on available clinical data may benefit from treatment with anti-PD-L1.
- Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
- ECOG performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Signed Informed Consent Form.
Key exclusion criteria (51 listed)
- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy within ≤14 days prior to 89Zr-MPDL3280A injection; the following exceptions are allowed:
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the 89Zr-MPDL3280A injection.
- Unstable brain metastases.
- Unstable leptomeningeal disease.
- Uncontrolled tumor-related pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-MPDL-3280A-PET scans89Zr-MPDL3280A tracer injection and 89Zr-MPDL-3280A-PET scans | Other | 1 |
Primary outcome
Description of 89Zr-MPDL3280A PK by measuring standardized uptake value (SUV) on the 89Zr-MPDL3280A-PET scans
Time frame: 2 years
3 secondary outcomes
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-MPDL3280A tumor uptake, evaluated by measuring standardized uptake value (SUV) on the 89Zr-MPDL3280A-PET.
Time frame: 2 years
Safety assessment through summaries of adverse events, changes in laboratory test results, changes in vital signs, and exposure to 89Zr-MPDL3280A. Adverse event data will be recorded and summarized according to NCI CTCAE v4.0.
Time frame: 2 years
To assess the level of MPDL3280A target saturation during treatment with MPDL3280A
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 42722782Hooiveld-Noeken JS, van de Donk PP, Kist de Ruijter L, Kok IC, van Winkel CAJ, Giesen D, Lub-de Hooge MN, Brouwers AH, Oosting SF, Bensch F, Smit LM, Schroder CP, Jalving M, Elias SG, Gietema JA, Deurloo RJ, Williams SP, Ungewickell A, de Groot DA, de Vries EGE. Programmed death ligand 1 (PD-L1) PET/CT imaging to evaluate tumour saturation during atezolizumab treatment. Br J Cancer. 2026 Sep 10. doi: 10.1038/s41416-026-03595-8. Online ahead of print.
- Derived from this study: PubMed 30478423Bensch F, van der Veen EL, Lub-de Hooge MN, Jorritsma-Smit A, Boellaard R, Kok IC, Oosting SF, Schroder CP, Hiltermann TJN, van der Wekken AJ, Groen HJM, Kwee TC, Elias SG, Gietema JA, Bohorquez SS, de Crespigny A, Williams SP, Mancao C, Brouwers AH, Fine BM, de Vries EGE. 89Zr-atezolizumab imaging as a non-invasive approach to assess clinical response to PD-L1 blockade in cancer. Nat Med. 2018 Dec;24(12):1852-1858. doi: 10.1038/s41591-018-0255-8. Epub 2018 Nov 26.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth de Vries, Professor principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 89Zr-MPDL-3280A-PET scans in people with Locally Advanced or Metastatic Solid Tumors Irrespective of PD-L1 Expression, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of 89Zr-MPDL3280A PK by measuring standardized uptake value (SUV) on the 89Zr-MPDL3280A-PET scans (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453984, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.