Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

An open-label, phase I multicenter, clinical trial of NECVAX-NEO1 in addition to anti-PD-1 or anti-PD-L1 monoclonal antibody checkpoint inhibitor monotherapy in patients with solid tumors

This clinical trial is designed to investigate a new medication called NECVAX-NEO1. This new drug will be given together with existing cancer treatments, which are a type of immunotherapy called anti-PD-1 or anti-PD-L1 checkpoint inhibitors. The study is for adults who have specific types of solid tumours, including non-small cell lung cancer, melanoma (a type of skin cancer), bladder cancer (urothelial cancer), kidney cancer (renal cell cancer), or head and neck cancer. This is one of the very first studies of NECVAX-NEO1 in humans (a 'Phase I' trial). The main goal is to check its safety and how it affects the body when combined with these standard treatments. Researchers want to understand if it could be a helpful new option for these cancers.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Nec Oncoimmunity AS

Enrolment target

Start

03 Jul 2024

Non-Small Cell Lung Cancer cutaneous melanoma urothelial cancer renal cell cancer Squamous Cell Carcinoma of the Head and Neck

What is this study about?

This study is looking into a new medication named NECVAX-NEO1. This drug is being tested alongside treatments you might already know about, which are a kind of immunotherapy called 'checkpoint inhibitors' (these are drugs like anti-PD-1 or anti-PD-L1). Immunotherapy helps your body's own immune system fight cancer. The researchers want to see if adding NECVAX-NEO1 to these existing treatments could make them more effective or bring new benefits.

The study is for people who have been diagnosed with certain types of solid tumours. These include non-small cell lung cancer, a serious type of skin cancer called melanoma, bladder cancer, kidney cancer, or head and neck cancer. By participating, you would be helping doctors learn more about this new medicine and whether it could be a future treatment option for these conditions.

This is a 'Phase I' study, which means it’s one of the first times this new medicine, NECVAX-NEO1, is being given to people. The main focus at this stage is to understand if the medicine is safe, what dose works best, and how the body handles it when combined with current treatments. It’s a crucial step in developing new medicines, and patient volunteers are essential for this vital research.

Key takeaways

This study tests a new medicine called NECVAX-NEO1 for certain solid cancers.
It combines NECVAX-NEO1 with existing cancer immunotherapies.
This is an early-stage study (Phase I) focused on safety and how the body reacts.
It is for adults aged 18 and over with specific cancer types.
Participation involves regular hospital visits for monitoring and tests.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Critically, you must have one of the specific types of solid cancer that the study is focusing on. These include non-small cell lung cancer, melanoma (a serious skin cancer), bladder cancer, kidney cancer, or a type of head and neck cancer.

Detailed rules about who can and cannot join are very important in every clinical trial. These rules ensure the study is safe for participants and that the results are clear. Your doctor would carefully check all these requirements with you to see if this study is a good fit.

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 non-small cell lung cancer, melanoma, bladder cancer, kidney cancer, or head and neck cancer?
Are you able to attend regular appointments and tests?
Are you able to understand and agree to the study procedures?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, NECVAX-NEO1, in addition to your standard cancer treatment (either an anti-PD-1 or anti-PD-L1 drug). This early-stage study typically involves regular visits to the hospital or clinic. During these visits, the study team would closely monitor your health, check for any side effects, and perform various tests. These tests might include blood samples, urine tests, and scans to see how your cancer is responding and how the medicine is affecting your body. The exact number and frequency of visits, as well as the total length of your participation, would be explained in detail by the study team. You would also have follow-up appointments after your treatment period to see how you are doing.

Potential risks and benefits

Potential benefits of joining this study include receiving a new, experimental treatment that may help with your cancer, and contributing to medical knowledge that could benefit future patients. However, as this is a new medicine, there are also potential risks of unknown side effects, or that the treatment may not work for you. The study team will explain all known risks and closely monitor your health. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Lithuania

Common questions

What is NECVAX-NEO1?

NECVAX-NEO1 is a new medicine being tested in this study. We don't yet know what it does or how it works, but the study aims to find this out.

What is a 'Phase I' trial?

A 'Phase I' trial is the first time a new medicine is given to people. The main goal is to check if it's safe and to find the right dose, rather than to see if it cures the disease.

What are 'anti-PD-1 or anti-PD-L1' treatments?

These are common types of immunotherapy for cancer. They help your body's own immune system find and fight cancer cells.

Will I get the new drug or a placebo?

In this specific study, everyone who participates will receive the new drug, NECVAX-NEO1, along with their standard immunotherapy.

How long will I be in the study?

The exact length of your participation will be discussed by the study team, as it can vary. There will also be follow-up appointments after your treatment period.