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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Maria
Martinez
+44 (0)20 3313 3170
pelican-trial@imperial.ac.uk
Dr
David
Pinato
+44 (0)20 7594 2799
david.pinato@imperial.ac.uk
Dr
David
Pinato
+44 (0)20 7594 2799
david.pinato@imperial.ac.uk
High-grade neuroendocrine tumours
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This is a single-arm, open-label phase II study for chemotherapy naïve patients with confirmed high-grade neuroendocrine tumours (HG-NETs). Patients enrolled on the study will receive carboplatin, etoposide and pembrolizumab as induction treatment before moving on to pembrolizumab and lenvatinib for maintenance treatment. The study will aim to assess the safety and efficacy of this combination of drugs, and this two-part treatment. Carboplatin plus etoposide is an already proven effective regimen against HG-NETs. However, a recognised challenge of this treatment is the development of resistance to these drugs. The addition of pembrolizumab to this treatment course is thought to have a synergistic effect and increase long-term disease control. Pembrolizumab is a monoclonal antibody designed to block the PD-1 receptor, which binds PDL-1 and PDL-2 ligands to counteract their anti-tumour response, thereby activating the body’s immune system to fight cancer cells. Lenvatinib blocks the activation of all Vascular Endothelial Growth Factors (VEGF) receptors to prevent the growth and proliferation of blood vessels in and around tumours cutting their supply of nutrients and oxygen thereby preventing further tumour growth.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Participants are excluded from the study if any of the following criteria apply:1. Has a diagnosis of large cell and small cell histology of lung origin or Merkel cell carcinoma.2. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. 3. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease and stereotactic radiotherapy to the CNS.4. Has an active infection requiring systemic therapy. 5. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.6. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA detectable levels) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. 7. Has a known history of active Bacillus Tuberculosis (TB).8. Has a known history of or any evidence of active pneumonitis.9. Has a known history of interstitial of lung disease.10. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 12. Uncontrolled blood pressure (Systolic BP>140 mmHg or diastolic BP >90 mmHg) in spite of an optimized regimen of antihypertensive medication.13. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug.14. Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumour shrinkage/necrosis following lenvatinib therapy.15. Subjects having >1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is <1 g/24 hours.16. Is currently participating and receiving therapy or has participated or is participating in a study of an IMP or used an investigational device within 4 weeks of the first dose of IMP.17. Has had major surgery within 3 weeks prior to first dose of study treatment. 18. Has a history of hypersensitivity to pembrolizumab, lenvatinib, carboplatin, etoposide or any of their excipients.19. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.20. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Principal Investigator (PI). 21. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.22. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through to 120 days after the last dose of IMP.23. Has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent.24. Has received a live vaccine within 30 days of first dose of IMP administration. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. It is advised that as a precautionary measure 24 hours should elapse between a dose of vaccine and the next dose of study drug
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Maria
Martinez
+44 (0)20 3313 3170
pelican-trial@imperial.ac.uk
Dr
David
Pinato
+44 (0)20 7594 2799
david.pinato@imperial.ac.uk
Dr
David
Pinato
+44 (0)20 7594 2799
david.pinato@imperial.ac.uk
The study is sponsored by Imperial College London and funded by Merck Sharp and Dohme.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 59994
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
