PELICAN
Research type
Research Study
Full title
A phase II study of etoposide-carboplatin (EP) chemotherapy in combination with pembrolizumab and lenvatinib maintenance in advanced high-grade neuroendocrine tumours (HG-NETs)
IRAS ID
1004397
Contact name
David Pinato
Contact email
Sponsor organisation
Imperial College London
Eudract number
2020-004105-30
ISRCTN Number
ISRCTN12812346
Research summary
This is a single arm, open label phase II study for chemotherapy naïve patients with confirmed high grade neuroendocrine tumours (HG-NETs). Patients enrolled onto the study will receive carboplatin, etoposide and pembrolizumab as induction treatment before moving onto pembrolizumab and lenvatinib for maintenance treatment. The study will aim to assess the safety and efficacy of these combination of drugs, and this two part treatment.
Carboplatin and etoposide is an already proven effective regime against HG-NETs. However, a recognised challenge of this treatment is the development of resistance to these drugs. 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.
Induction treatment will consist of a three-weekly cycle of carboplatin at 5AUC administered intravenously at day 1 of the cycle, followed by etoposide 100mg/m2 on day 2 and 3, and pembrolizumab at 200mg on all 3 days. After 4 cycles, the patients will then move onto the maintenance treatment phase and be given 200mg pembrolizumab (via IV again) every 3 weeks whilst taking oral lenvatinib 20mg daily. Patients will continue on this course until unacceptable toxicity, disease progression, withdrawal or completion of 2 years. A form of imaging scan known as CT will be performed at 21 days after induction treatment and then 9 weekly thereafter to assess disease response.
20 patients will be recruited across 4 sites.
REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0648
Date of REC Opinion
15 Nov 2023
REC opinion
Further Information Favourable Opinion