Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas

This study is investigating a new medication called DYP688 for people who have advanced uveal melanoma (a type of eye cancer that has spread) or other rare melanomas with specific genetic changes (called GNAQ/11 mutations). The study has two main parts. In the first part, researchers will carefully increase the dose of DYP688 to find the safest and most effective amount. In the second part, they will give this dose to more patients to see how well it works to shrink or control the cancer. This research aims to understand if DYP688 could be a helpful treatment option for these conditions.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

Start

04 Jul 2022

Estimated completion

01 Oct 2027

Metastatic Uveal Melanoma

What is this study about?

This research study is looking into a new medication, DYP688, for people with specific types of melanoma that have unfortunately spread to other parts of the body. The main focus is on uveal melanoma, which is a rare type of cancer that starts in the eye. It's also for other less common melanomas that have particular genetic changes, known as GNAQ/11 mutations.

The study has two stages. The first stage is about finding the right dose of DYP688. Researchers will start with a low dose and gradually increase it in a small group of patients, carefully watching for any side effects. This helps them find a dose that is both safe and has the best chance of working against the cancer. Once a safe and effective dose is found, the study moves to the second stage.

In the second stage, more patients will receive the identified dose. This larger group will include people with uveal melanoma, both those who have tried a previous treatment called tebentafusp and those who haven't. There might also be a small group of people with other melanomas that have the specific GNAQ/11 genetic changes. The overall goal is to understand how well DYP688 works to control or shrink the cancer and to continue monitoring its safety.

Key takeaways

Tests a new drug (DYP688) for advanced uveal melanoma and GNAQ/11 mutant melanomas.
Aims to find a safe dose and see how well it works.
Involves regular check-ups, blood tests, and scans.
Participation is voluntary, and you can withdraw at any time.
Potential for a new treatment, but also possible unknown side effects.

Who may be eligible?

To be considered for this study, most participants need to be at least 18 years old. However, for some parts of the study, younger individuals, aged 12 and above, might be able to take part if allowed in their country, provided they weigh at least 40 kg (about 6 stone 4 pounds). All participants need to be well enough to carry out most daily activities without too much difficulty.

For those with uveal melanoma that has spread, you might be eligible whether you've had previous treatments or not, as long as your cancer has progressed. If you have another type of melanoma (not uveal) that has spread, you would need to have tried all standard treatments or have no other good treatment options, and your cancer must have the specific GNAQ/11 genetic changes.

It's important that you are able and willing to have biopsies (taking small tissue samples) if the study requires them, though exceptions might be considered if a biopsy isn't medically possible for you.

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 generally aged 18 or older (or 12+ if specific conditions apply)?
Do you have uveal melanoma that has spread, or another melanoma with specific GNAQ/11 genetic changes?
Are you able to manage most of your daily activities without much help?
Are you willing and able to undergo study-required biopsies?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be taking a new medication called DYP688. The study involves regular visits to the clinic for assessments. These will include check-ups by doctors, blood tests, and scans to see how your body is responding to the treatment and whether the cancer is changing. You might also need to have biopsies collected to understand more about your cancer and how the drug is working. The exact number of visits and tests will be explained in detail by the study team, and it will depend on which part of the study you are in. You will take the medication for as long as it benefits you and you tolerate it well, with regular follow-up appointments after you stop taking the drug.

Potential risks and benefits

Participating in this study might offer a potential benefit: you could receive a new treatment, DYP688, that isn't yet widely available, which might help control your cancer. However, it's also important to be aware of potential risks. As DYP688 is a new drug, there could be side effects that are not yet fully known or understood, including serious ones. The research team will monitor you closely for any adverse effects. Remember, joining a clinical study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (11)

Massachusetts General Hospital Hematology Oncology
Verified postcode
Boston, United States
Columbia University Medical Center- New York Presbyterian Onc Dept
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New York, United States
Memorial Sloane Kettering Cancer Center MSKCC
Verified postcode
New York, United States
Novartis Investigative Site
Verified postcode
Westmead, Australia
Novartis Investigative Site
Verified postcode
Melbourne, Australia
Novartis Investigative Site
Verified postcode
Paris, France
Novartis Investigative Site
Verified postcode
Essen, Germany
Novartis Investigative Site
Verified postcode
Heidelberg, Germany
Novartis Investigative Site
Verified postcode
Leiden, Netherlands
Novartis Investigative Site
Verified postcode
Madrid, Spain
Novartis Investigative Site
Verified postcode
Zurich, Switzerland

Common questions

What is uveal melanoma?

Uveal melanoma is a rare type of cancer that begins in the eye. In this study, we are looking at it when it has spread to other parts of the body.

What are GNAQ/11 mutations?

These are specific genetic changes found in some melanomas. This study is for people whose cancer has these particular changes.

What does 'First in Human' mean?

It means this is one of the first times this new drug, DYP688, is being tested in people. This is a very early stage of research.

Will I get a placebo (dummy drug)?

No, in this study, everyone will receive the active medication, DYP688. There is no placebo group.

How long does the study last?

You will continue to receive the study drug for as long as it is helping you and you are tolerating it well. There will be follow-up appointments after you stop the drug.