Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors

This study investigates new ways to treat advanced cancers with drugs called durvalumab and monalizumab. It's for adults whose cancer has come back or spread. The main goals are to check if these new drug combinations are safe, how well people tolerate them, and if they can shrink tumours. We'll also look at how the drugs move through the body and affect the immune system. The study has different parts: first, finding the right dose, then testing that dose further, and finally, looking at these drugs in combination with standard treatments, especially for bowel cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

MedImmune LLC

Enrolment target

383

Start

22 Feb 2016

Estimated completion

01 Sep 2025

Advanced Solid Tumors

Results

Results from this study

Posted March 2023

Results have been published for this study.

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Any TEAEs data is inclusive of both serious and other adverse events (non-serious).

Full results on the registry

What is this study about?

This research is looking for new and better ways to treat advanced solid tumours. These are cancers that have grown or spread to other parts of the body. The study focuses on two investigational drugs: durvalumab and monalizumab. Researchers want to see if using these drugs together, or in combination with other standard cancer treatments, could be an effective option.

The study has a few stages. Initially, a small group of patients will receive increasing doses of durvalumab and monalizumab to find the safest and most effective amount to give. Once the best dose is found, more patients will receive this dose to confirm its safety and see how well it works against different types of advanced solid tumours.

Finally, the study will look specifically at patients with advanced bowel cancer. For these patients, researchers will be testing durvalumab and monalizumab alongside conventional treatments that doctors usually give for bowel cancer, or monalizumab with other biological agents. This helps to understand if these new combinations can improve outcomes.

Key takeaways

This study is testing new drug combinations for advanced cancers.
It aims to find safe doses and see if these drugs can fight tumours.
Participation involves regular hospital visits, tests, and receiving study drugs.
You might receive new drugs alone or with standard cancer treatments.
Your involvement could help advance cancer research for future patients.

Who may be eligible?

To join this study, you would need to have an advanced cancer that has either come back or spread to other parts of your body, and your doctor would need to confirm the type of cancer from previous tests. A key requirement is that your cancer must have at least one spot that doctors can measure to see if the treatment is working.

For patients with advanced bowel cancer being considered for a specific part of the study, you might be able to join even if you haven't had much previous treatment for your widespread cancer. However, you shouldn't have had more than two types of standard systemic treatment for the cancer that has spread.

There are also some reasons why you might not be able to join. For example, if you've recently had certain other cancer treatments or an immunotherapy drug before, you might not be eligible. Also, you can't be taking part in another clinical study involving durvalumab where the main results aren't yet known.

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.

Is my cancer advanced, or has it come back or spread?
Do I have a solid tumour type of cancer?
Do I have an area of cancer that doctors can measure?
Have I avoided recent immunotherapy treatments?
Am I over 18 years old?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would have medical checks, blood tests, and scans (like CT scans) to monitor your health and see how the treatment is affecting your cancer. You would receive the study drugs (durvalumab, monalizumab, and potentially other standard treatments) as prescribed by the study doctors.

The drugs would be given according to a specific schedule, which your study team will explain in detail. You'd need to tell the team about any side effects you experience. The total length of your participation would depend on how your body responds to the treatment and the study's design. The study team will explain the full schedule of visits, tests, and follow-up during the consent process.

Potential risks and benefits

While we hope this study will lead to new and better treatments for advanced cancers, there’s no guarantee that you will personally benefit from taking part. You might experience side effects from the study drugs, some of which could be serious, and the treatment may not improve your cancer. However, your participation could help us learn more about treating advanced cancers, potentially benefiting future patients. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (49)

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

Research Site
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Birmingham, United States
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Scottsdale, United States
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Duarte, United States
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La Jolla, United States
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Los Angeles, United States
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Sacramento, United States
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Santa Monica, United States
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Aurora, United States
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Tampa, United States
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Chicago, United States
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Baltimore, United States
Research Site
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Boston, United States

Common questions

What kind of cancers is this study for?

It's for adults with advanced solid tumours, which means cancers that have spread or returned, including a specific part looking at advanced bowel cancer.

What are durvalumab and monalizumab?

They are investigational drugs, meaning they are still being studied, and are a type of treatment that works with your body's immune system to fight cancer.

Will I get standard cancer treatment in this study?

In some parts of the study, especially for bowel cancer, the new drugs will be given alongside standard cancer treatments you might already be familiar with.

Why are there different 'parts' to the study?

The different parts help researchers first find the safest dose of the new drugs, then confirm their safety and how well they work, and finally test them in specific cancer types or with existing treatments.

Can I join if I've had cancer treatment before?

Yes, but there are specific rules. For example, you generally can't have had immunotherapy drugs before, and for bowel cancer, you shouldn't have had more than two previous treatments for the spread cancer.