Spots Global Cancer Trial Database for A Study of Etoposide-carboplatin in Combination With Pembrolizumab and Lenvatinib Maintenance in HG-NETs

Study Description

Brief Summary: This is an open label, single arm, phase II multicentre study designed to evaluate the efficacy and safety of pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in patients with HG-NETs who are chemotherapy-naïve for their metastatic disease. The study will be conducted in up to 10 sites and will recruit up to a maximum of 20 evaluable participants.

Detailed Description: This is an open label, single arm, phase II multicentre study designed to evaluate the efficacy and safety of pembrolizumab in combination with carboplatin and etoposide chemotherapy followed by pembrolizumab and lenvatinib maintenance therapy in patients with HG-NETs who are chemotherapy-naïve for their metastatic disease. The study will be conducted in up to 10 sites and will recruit up to a maximum of 20 evaluable participants. Patients who satisfy study inclusion criteria will be offered the possibility of participating in the study. A patient information sheet and a written consent form will be offered to every patient. Informed consent must be obtained prior to initiation of any clinical screening procedure that is performed solely for the purpose of determining eligibility for research. Investigators must ensure that subjects are clearly and fully informed about the purpose of the study, in which they volunteer to participate. In situations where consent cannot be given to subjects, their legally acceptable representatives are clearly and fully informed about the purpose, the subject volunteers to participate. The consent form which will include all elements required by ICH, GCP and applicable regulatory, and will adhere to the ethical principles that have their origin in the Declaration of Helsinki. Following written content, investigators will assess: * Patient's Demographics and Medical History; * Patient's Eligibility Confirmation; The treatment schedule recognizes an induction phase and a maintenance phase. Induction Phase. Following informed consent and screening investigations (28 days window) patients will receive 4 cycles of induction chemotherapy with carboplatin (AUC 5mg/ml/min) administered IV alongside etoposide (120 mg/m2) and pembrolizumab (200 mg IV) on day 1 of a 21-days cycle, followed by oral etoposide (100 mg twice daily) on day 2-3 of each cycle. Maintenance Phase. In patients who achieve a complete, partial response or stable disease following induction, maintenance pembrolizumab (200 mg IV on day 1 every 21 days) and lenvatinib (20 mg PO daily) will start following completion of induction treatment and will continue until unacceptable toxicity, disease progression, withdrawal of consent or completion of 2 years of treatment. In days when Lenvatinib is co-administered with pembrolizumab, lenvatinib should be administered prior to pembrolizumab, ideally in the morning of the study visit. Re-staging by computerised tomography (CT) will be performed 21 days after completion of induction then 9-weekly until study completion. A second, optional tumour biopsy will be taken at C3 Day 1 (+/- 14 days).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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