Study of Darovasertib and Crizotinib for Patients with Metastatic Uveal Melanoma Who Are HLA-A2 Negative

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What is this study about?

This clinical trial is focused on studying a type of eye cancer called metastatic uveal melanoma, specifically in patients who are HLA-A2 negative. The study will explore the effectiveness of a new treatment combination using the medications IDE196 (Darovasertib) and Crizotinib. These medications are being tested as a first-line therapy, which means they are used as the initial treatment for this cancer. The purpose of the study is to determine the best dose of this combination and to compare its effectiveness to other treatments chosen by doctors.

Participants in the study will receive either the combination of IDE196 and Crizotinib or another treatment selected by their doctor, which may include medications like Ipilimumab, Nivolumab, Pembrolizumab, or Dacarbazine. The study will be conducted in phases, starting with Phase 2a to find the optimal dose, followed by Phase 2b and Phase 3 to compare the new treatment with existing options. The study will monitor the progression of the disease and overall survival of the participants.

Throughout the study, participants will be closely observed for any side effects and changes in their health. The trial aims to provide valuable information on how well the new treatment works compared to other available therapies. This research is important for developing better treatment options for patients with metastatic uveal melanoma.

1 joining the study

Upon joining the study, the participant will be required to provide written, informed consent. This ensures understanding and agreement to comply with the study requirements.

Eligibility will be confirmed based on criteria such as age, health status, and previous treatments.

2 phase 2a: dose determination

The initial phase involves determining the optimal dose of IDE196 (Darovasertib) combined with Crizotinib. This combination is administered orally in tablet form.

The goal is to establish a recommended dose for subsequent phases.

3 phase 2b: treatment comparison

Participants will receive either the IDE196 and Crizotinib combination or an alternative treatment chosen by the investigator.

The effectiveness of the treatments will be compared based on progression-free survival, which measures the time until the disease progresses or the participant passes away.

4 phase 3: overall survival comparison

In this phase, the focus is on comparing the overall survival rates between the IDE196 and Crizotinib combination and the investigator’s choice of treatment.

Overall survival is defined as the time from randomization until death from any cause.

5 medication administration

The study involves various medications administered through different routes. IDE196 and Crizotinib are taken orally as tablets.

Other medications like Ipilimumab, Nivolumab, and Pembrolizumab are given through infusion, while Dacarbazine is administered via intravenous infusion.

6 monitoring and assessments

Participants will undergo regular monitoring to assess the treatment’s effects and any side effects. This includes laboratory tests, ECGs, and vital sign checks.

Progression-free survival and overall survival will be evaluated, along with other response measures.

7 end of study

The study is estimated to conclude by December 31, 2027. Participants will be followed up to assess long-term outcomes and any lasting effects of the treatment.

Who Can Join the Study?

Must be at least 18 years old.
Must provide written, informed consent before starting any study-related procedures and be able to follow all study requirements.
Must have a confirmed diagnosis of metastatic uveal melanoma, which means the cancer has spread from the eye to other parts of the body.
Must be HLA-A*02:01 negative, which is a specific genetic marker.
Must not have had any previous systemic treatments for metastatic or advanced cancer, such as chemotherapy or immunotherapy.
Must provide a sample of the tumor tissue for testing, either from a previous surgery or a new biopsy, unless it’s not medically possible.
Must have at least one tumor that can be measured accurately using a CT or MRI scan.
Must be able to safely receive and absorb the study treatment.
Must have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have a life expectancy of at least 3 months.
Must have adequate organ function, which includes specific blood counts and liver and kidney function tests.
Women who can become pregnant must use highly effective birth control during the study and for 6 months after the last dose of the study treatment.
Men must be surgically sterile or agree to use double barrier contraception methods during the study and for 6 months after the last dose of the study treatment.

Who Cannot Join the Study?

Patients who do not have HLA-A2 negative metastatic uveal melanoma. This means the study is only for those with a specific type of eye cancer that has spread to other parts of the body and who have a particular genetic marker called HLA-A2.
Patients who are not within the specified age range. The study is open to certain age groups, so if you are outside of these age ranges, you cannot participate.
Patients who are not male or female. The study is open to both men and women, so if you do not identify as either, you may not be eligible.
Patients who are considered part of a vulnerable population. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Uuqpxygbpuyrfgoienbmh Eacpz Axb	Essen	Germany
Ibrxwqpu Chxpmc Dptisoxxkxayossjb	L'hospitalet De Llobregat	Spain
Csdcwmjtc Ugnabvcizidlsj Skbmyuqxq	Woluwe-Saint-Lambert	Belgium
Uhazjnrmdq Htjjezjp Clsowsr	Cologne	Germany
Aqtafbe Odojlleofhk Uutqksuydtqpj Scbpum	Siena	Italy
Utbexhnchspwju Cedqgtq Klkrfbokc	Gdansk	Poland
Cgkzuc Lokc Bbxmhl	Lyon	France
Fhbkucvua Pxql Ll Izxkxekqpyztj Byrujdwkf Dlb Hadmogwe Ucoinhyhvgrxs Lf Pyl	Madrid	Spain
Iqyyupkk Coqxd	Paris	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.07.2024
France	Recruiting	01.07.2024
Germany	Recruiting	01.07.2024
Italy	Recruiting	01.07.2024
Poland	Recruiting	01.07.2024
Spain	Recruiting	01.07.2024
The Netherlands	Recruiting	01.07.2024

Trial locations

Investigated drugs:

IDE196 (Darovasertib) is a medication being studied for its potential to treat metastatic uveal melanoma, a type of eye cancer. It is being tested in combination with another drug to see if it can help stop or slow down the growth of cancer cells.

Crizotinib is a medication that is used in combination with IDE196 in this clinical trial. It is known to target specific proteins in cancer cells, which may help to stop the cancer from growing and spreading. The combination of Crizotinib with IDE196 is being evaluated to determine if it is more effective than other treatments chosen by doctors.

Investigated diseases:

Uveal melanoma

Metastatic Uveal Melanoma – This is a rare type of cancer that originates in the uveal tract of the eye, which includes the iris, ciliary body, and choroid. It is characterized by the spread of cancer cells from the eye to other parts of the body, most commonly the liver. The disease progresses as the cancerous cells invade surrounding tissues and organs, leading to the formation of secondary tumors. Symptoms may include changes in vision, eye pain, or visible changes in the eye, although these can vary depending on the extent and location of metastasis. As the disease advances, it can affect the function of the organs involved, particularly if the liver is affected.

Trial ID:

2023-506686-66-01

Protocol code:

IDE196-002

NCT ID:

NCT05987332

Trial Phase:

Therapeutic use (Phase IV)

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Study of Darovasertib and Crizotinib for Patients with Metastatic Uveal Melanoma Who Are HLA-A2 Negative

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?