Active not recruitingPHASE2INTERVENTIONAL

A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition

This research study is for people with advanced melanoma, a type of skin cancer, that has become resistant to previous immunotherapy treatments. Researchers are testing a new drug called Ceralasertib, both by itself and in combination with another drug called Durvalumab. The main goal is to understand how effective these treatments are in shrinking tumours and how well participants tolerate them. There's also an optional part of the study where participants might be asked to have additional tissue samples taken to help researchers learn more about how the drugs work at a cellular level. This study is for anyone aged 18 and over, of any sex.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

194

Start

11 Aug 2022

Estimated completion

02 Nov 2026

Melanoma

Results

Results from this study

Posted May 2025

Results have been published for this study.

Primary outcome

Main Study: Objective Response Rate (ORR)

ORR was defined as the proportion of participants who had a complete response (CR) or partial response (PR) prior to any evidence of progression (as defined by Response Evaluation Criteria in Solid Tumours \[RECIST\] 1.1) that is confirmed at least 4 weeks later. As per planned in protocol, this outcome measure was assessed only for main study.

Full results on the registry

What is this study about?

This research study is focusing on melanoma, a serious type of skin cancer. Specifically, it's for people whose melanoma has spread and can't be removed by surgery, and crucially, has stopped responding to a common type of treatment called immunotherapy (like drugs that block PD-1 or PD-L1 pathways).

The main aim of this study is to investigate a new drug called Ceralasertib. We want to see how effective Ceralasertib is when given by itself, and also how well it works when combined with another established immunotherapy drug called Durvalumab. We will be carefully monitoring participants to understand if these treatments help to control their melanoma and what side effects they might experience. This information is important for potentially offering new options to people whose cancer has become challenging to treat.

There's also an optional part of the study for some participants where doctors will collect extra small tissue samples (biopsies) at different times. This helps researchers understand more about how the cancer changes and how the treatments affect it at a microscopic level, which can lead to better understanding and future treatments. Your safety and well-being will be the priority throughout the study.

Key takeaways

This study is for advanced melanoma that has stopped responding to prior immunotherapy.
It tests a new drug, Ceralasertib, by itself and with Durvalumab.
The main goals are to assess treatment effectiveness and safety.
An optional part involves extra tissue samples to learn more about the cancer.
Participation involves regular clinic visits for monitoring and scans.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you must have been diagnosed with melanoma that has spread or cannot be removed by surgery. It's important that your melanoma has previously been treated with at least one type of immunotherapy, and unfortunately, it has since started to grow again despite that treatment.

You also need to have some existing tissue samples from your cancer available, and be willing to have a new tissue sample taken when you join the study. Doctors will need to see that your cancer can be measured accurately, and you should be in generally good health with a life expectancy of at least three months.

There are also some reasons why you might not be able to join. For example, if you had very severe side effects from your previous immunotherapy that led to stopping the treatment permanently, or if you have certain other serious medical conditions like a recent history of another cancer (unless it was completely cured a long time ago) or significant heart problems. The study is not for people with uveal melanoma, which is a type of eye melanoma.

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.

Do I have advanced melanoma that can't be removed by surgery?
Has my melanoma been treated with immunotherapy before, but it's now growing again?
Am I willing to provide a new tissue sample (biopsy) at the start of the study?
Do I have any serious heart conditions or a history of severe immune-related side effects from previous immunotherapy?
Is my melanoma not uveal melanoma (a type that affects the eye)?
Am I aged 18 or older?

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, you will receive either Ceralasertib alone or Ceralasertib combined with Durvalumab according to the study plan. The study will involve regular visits to the clinic for medical check-ups, blood tests, and scans (like CT or MRI scans) to see how the treatment is working and monitor for any side effects. You will be given the study medication as directed by the clinical team.

For some participants, there's an optional sub-study that involves having three additional small tissue biopsies. These would be taken at the start of the study, during your Ceralasertib treatment, and after you stop Ceralasertib treatment. The total length of your participation will depend on how you respond to the treatment and your progress, but there will be ongoing follow-up to monitor your health.

Potential risks and benefits

Participating in this study might offer a potential benefit of trying a new treatment for your melanoma if standard treatments are no longer effective. However, as with any medical treatment, there are potential risks, including side effects from the study drugs. These side effects can vary and will be carefully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (66)

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

Research Site
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Los Angeles, United States
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Sacramento, United States
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San Francisco, United States
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Tampa, United States
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Lutherville-Timonium, United States
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Nashville, United States
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Darlinghurst, Australia
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East Melbourne, Australia
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Herston, Australia
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Woolloongabba, Australia
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Belgium, Belgium
Research Site
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Bruges, Belgium

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that has the potential to spread to other parts of the body.

What does 'resistant to PD-(L)1 inhibition' mean?

It means your melanoma has stopped responding to a common type of immunotherapy treatment that targets the PD-1 or PD-L1 pathway.

Are the study drugs new?

Ceralasertib is a new drug being tested, while Durvalumab is an established immunotherapy drug. This study looks at Ceralasertib alone and in combination with Durvalumab.

Will I know which treatment I'm receiving?

Yes, this is an 'open-label' study, which means both you and your doctor will know which treatment you are receiving.

What is a biopsy and why might I need one?

A biopsy is a small tissue sample taken for examination. In an optional sub-study, these extra biopsies help researchers understand how the drugs affect your cancer at a detailed level.