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New drug combo targets rare genetic tumor marker in observational trial

NCT ID NCT06262919

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study watches how safe and effective two drugs, dabrafenib and trametinib, are for people with advanced or recurrent solid tumors that have a specific genetic change called BRAF V600E. About 110 adults and children will be followed to track side effects and tumor shrinkage. The goal is to see if these drugs can control the disease in real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

patients who used the product for the treatment of BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) as per the package insert.

Ages

6 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients who have given written consent to cooperate in this surveillance 2. For patients aged \< 18 years at the start of treatment with the product, their legally authorized representative must have given written informed consent for cooperation in this surveillance prior to patient enrollment. 3. Patients who start treatment with the product for BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications Exclusion Criteria: 1. Patients who have received or are receiving a product containing the same ingredient as the product in any other study or research than this surveillance 2. Patients with BRAF-mutation-positive malignant melanoma 3. Patients with BRAF-mutation-positive non-small cell lung cancer 4. Patients with BRAF-mutation-positive hairy cell leukemia

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Conditions

The condition(s) this trial relates to.

Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRAF V600E mutation-positive unresectable advanced or recurrent solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    COMPLETED

    Nagakute, Aichi-ken, 480-1195, Japan

  • Novartis Investigative Site

    RECRUITING

    Nagoya, Aichi-ken, 453-8511, Japan

  • Novartis Investigative Site

    COMPLETED

    Nagoya, Aichi-ken, 453-8511, Japan

  • Novartis Investigative Site

    COMPLETED

    Nagoya, Aichi-ken, 4648681, Japan

  • Novartis Investigative Site

    COMPLETED

    Toyohashi, Aichi-ken, 441-8570, Japan

  • Novartis Investigative Site

    COMPLETED

    Toyota, Aichi-ken, 470-0343, Japan

  • Novartis Investigative Site

    COMPLETED

    Daisen, Akita, 0140027, Japan

  • Novartis Investigative Site

    WITHDRAWN

    Chiba, Chiba, 2608677, Japan

  • Novartis Investigative Site

    COMPLETED

    Funabashi, Chiba, 273-8588, Japan

  • Novartis Investigative Site

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Novartis Investigative Site

    RECRUITING

    Yoshida-gun, Fukui, 910-1193, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, Fukuoka, 811-1395, Japan

  • Novartis Investigative Site

    RECRUITING

    Kurume, Fukuoka, 830-0011, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuyama, Hiroshima, 721-8511, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0608543, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0650033, Japan

  • Novartis Investigative Site

    COMPLETED

    Amagasaki, Hyōgo, 660-8511, Japan

  • Novartis Investigative Site

    COMPLETED

    Kobe, Hyōgo, 650-0011, Japan

  • Novartis Investigative Site

    RECRUITING

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    RECRUITING

    Mito, Ibaraki, 311-4145, Japan

  • Novartis Investigative Site

    COMPLETED

    Morioka, Iwate, 0200066, Japan

  • Novartis Investigative Site

    RECRUITING

    Sagamihara, Kanagawa, 252-0375, Japan

  • Novartis Investigative Site

    RECRUITING

    Yokohama, Kanagawa, 236-0004, Japan

  • Novartis Investigative Site

    RECRUITING

    Yokohama, Kanagawa, 245-8575, Japan

  • Novartis Investigative Site

    RECRUITING

    Kyoto, Kyoto, 602-8566, Japan

  • Novartis Investigative Site

    COMPLETED

    Natori-shi, Miyagi, 981-1293, Japan

  • Novartis Investigative Site

    RECRUITING

    Sendai, Miyagi, 9808574, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Iida, Nagano, 395-8502, Japan

  • Novartis Investigative Site

    RECRUITING

    Matsumoto, Nagano, 3908621, Japan

  • Novartis Investigative Site

    COMPLETED

    Matsumoto, Nagano, 3908621, Japan

  • Novartis Investigative Site

    RECRUITING

    Yufu, Oita Prefecture, 8795593, Japan

  • Novartis Investigative Site

    RECRUITING

    Okayama, Okayama-ken, 7011192, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Habikino, Osaka, 583-0872, Japan

  • Novartis Investigative Site

    COMPLETED

    Izumisano, Osaka, 5988577, Japan

  • Novartis Investigative Site

    RECRUITING

    Osaka, Osaka, 5340021, Japan

  • Novartis Investigative Site

    COMPLETED

    Osaka, Osaka, 5340021, Japan

  • Novartis Investigative Site

    COMPLETED

    Osaka, Osaka, 550-0015, Japan

  • Novartis Investigative Site

    RECRUITING

    Takatsuki, Osaka, 5698686, Japan

  • Novartis Investigative Site

    RECRUITING

    Kawagoe, Saitama, 3508550, Japan

  • Novartis Investigative Site

    RECRUITING

    Saitama, Saitama, 330-8777, Japan

  • Novartis Investigative Site

    RECRUITING

    Ohtsu, Shiga, 5202192, Japan

  • Novartis Investigative Site

    RECRUITING

    Sunto Gun, Shizuoka, 4118777, Japan

  • Novartis Investigative Site

    COMPLETED

    Shimotsuke, Tochigi, 329-0498, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo Ku, Tokyo, 113-8655, Japan

  • Novartis Investigative Site

    COMPLETED

    Bunkyo Ku, Tokyo, 113-8655, Japan

  • Novartis Investigative Site

    COMPLETED

    Bunkyo-ku, Tokyo, 113-8603, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Novartis Investigative Site

    COMPLETED

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Novartis Investigative Site

    RECRUITING

    Chuo Ku, Tokyo, 104-8560, Japan

  • Novartis Investigative Site

    COMPLETED

    Chuo Ku, Tokyo, 1040045, Japan

  • Novartis Investigative Site

    RECRUITING

    Chuo Ku, Tokyo, 1040045, Japan

  • Novartis Investigative Site

    RECRUITING

    Minato-ku, Tokyo, 105-8471, Japan

  • Novartis Investigative Site

    COMPLETED

    Minato-ku, Tokyo, 108-8639, Japan

  • Novartis Investigative Site

    RECRUITING

    Setagaya-ku, Tokyo, 1578535, Japan

  • Novartis Investigative Site

    COMPLETED

    Shibuya City, Tokyo, 150-8308, Japan

  • Novartis Investigative Site

    COMPLETED

    Shinjuku Ku, Tokyo, 160-0023, Japan

  • Novartis Investigative Site

    COMPLETED

    Shinjuku Ku, Tokyo, 1628666, Japan

  • Novartis Investigative Site

    RECRUITING

    Shinjuku-ku, Tokyo, 1608582, Japan

  • Novartis Investigative Site

    COMPLETED

    Wakayama, Wakayama, 641-8510, Japan

  • Novartis Investigative Site

    RECRUITING

    Wakayama, Wakayama, 641-8510, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Yamagata, Yamagata, 990-9585, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Akita, 0108543, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    RECRUITING

    Hiroshima, 7348551, Japan

  • Novartis Investigative Site

    RECRUITING

    Kagoshima, 8908520, Japan

  • Novartis Investigative Site

    RECRUITING

    Kochi, 7818555, Japan

  • Novartis Investigative Site

    RECRUITING

    Kyoto, 6068507, Japan

  • Novartis Investigative Site

    RECRUITING

    Okayama, 7008558, Japan

  • Novartis Investigative Site

    COMPLETED

    Osaka, 5458586, Japan

  • Novartis Investigative Site

    RECRUITING

    Shizuoka, 4208660, Japan