Active not recruitingPHASE2INTERVENTIONAL

A Study of Etoposide-carboplatin in Combination With Pembrolizumab and Lenvatinib Maintenance in HG-NETs

This research study is investigating a new treatment approach for people with high-grade neuroendocrine tumours (HG-NETs) that have spread and have not received chemotherapy for their advanced disease. The study combines an immunotherapy drug called pembrolizumab with standard chemotherapy (carboplatin and etoposide). After an initial treatment period, patients will continue with a combination of pembrolizumab and another drug called lenvatinib as a maintenance therapy. The main goal is to find out how safe and effective this new treatment combination is. This is a small study, involving up to 20 participants across several different hospitals, to gather important information for future treatment options.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Imperial College London

Enrolment target

Start

08 Jul 2024

Estimated completion

15 Oct 2027

Neuroendocrine Tumors

What is this study about?

This study is for individuals diagnosed with a specific type of cancer called a high-grade neuroendocrine tumour (HG-NET). Neuroendocrine tumours are a group of unusual cancers that start in specialised cells called neuroendocrine cells. These cells have features of both nerve cells and hormone-producing cells. High-grade means the cancer cells look more abnormal and tend to grow and spread more quickly. This particular study is for people whose HG-NETs have spread to other parts of their body (metastatic disease) and who have not yet received chemotherapy for this advanced stage.

The researchers are testing a new way of using existing medicines. The treatment involves two main stages. The first stage, called the 'induction phase', combines a type of immunotherapy called pembrolizumab with chemotherapy drugs (carboplatin and etoposide). Immunotherapy helps your body's own immune system fight cancer. The second stage, called the 'maintenance phase', involves continuing with pembrolizumab along with another drug called lenvatinib. This phase aims to keep the cancer under control after the initial treatment.

The main purpose of this study is to see how well these new combinations of medicines work in treating HG-NETs and to understand any side effects or risks they might have. It's a 'Phase II' study, which means it's an early-stage study designed to gather more information about a treatment that has shown some promise in earlier, smaller studies. The results will help doctors decide if this treatment approach should be investigated further in larger studies.

Key takeaways

Investigation of a new treatment combination for high-grade neuroendocrine tumours that have spread.
Combines immunotherapy (pembrolizumab) with chemotherapy, followed by a maintenance therapy.
Aims to assess the safety and effectiveness of this new approach.
Open to patients whose metastatic HG-NETs have not been treated with chemotherapy before.
This is an early-stage (Phase II) study involving a small number of participants.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. You should have a confirmed diagnosis of a poorly differentiated neuroendocrine tumour, which means the cancer cells look very abnormal under a microscope and are growing quickly. Your cancer needs to have spread, and you must not have received any previous chemotherapy for this advanced stage of your disease.

Doctors will also need to be able to measure your cancer to see if the treatment is working. You will need to be well enough to take part, as assessed by a doctor, and have healthy organ function. For women who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective contraception throughout the study and for a period afterwards. Men who are sexually active will also need to use adequate contraception.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a confirmed diagnosis of a high-grade neuroendocrine tumour that has spread?
Have you NOT received chemotherapy for your advanced disease yet?
Are you generally well enough to participate in a clinical trial?
If you are a woman who could become pregnant, are you willing to use effective contraception?
If you are a sexually active man, are you willing to use effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive detailed information and have time to ask questions before signing a consent form. This ensures you fully understand what's involved. Before starting treatment, doctors will review your medical history and perform tests to confirm you're suitable for the study.

The treatment has two main parts. The first part, called the 'induction phase', involves receiving treatment every 21 days for four cycles. This will include intravenous (into a vein) administration of three drugs: carboplatin, etoposide, and pembrolizumab on day 1 of each cycle, followed by oral etoposide tablets on days 2 and 3. If your cancer responds well, or stays stable, you will then move to the 'maintenance phase', which continues with pembrolizumab and lenvatinib. The full duration of the study commitment and follow-up will be explained by the study team.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing new or experimental treatments that are not yet widely available. While this study is testing existing drugs in a new combination, there are always potential risks and side effects associated with any medication, and these will be thoroughly explained to you by the study team. You might experience side effects from the chemotherapy, immunotherapy, or targetted therapy drugs used. There's also no guarantee that the treatment will be effective for everyone. Importantly, you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom

Common questions

What is a high-grade neuroendocrine tumour?

It's a type of uncommon cancer that grows from special cells, and 'high-grade' means the cancer cells are more aggressive and tend to grow faster.

What is 'immunotherapy'?

Immunotherapy is a type of treatment that helps your body's own immune system find and fight cancer cells more effectively.

What does 'maintenance therapy' mean?

After the initial main treatment, maintenance therapy is given to help keep the cancer under control and prevent it from growing or coming back for as long as possible.

How many people are taking part in this study?

This is a small study, so up to 20 people in total will be participating across several different hospitals.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect the medical care you receive.