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Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04544202
Expanded Access Status : Available
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this Treatment Plan is to allow access to trametinib and dabrafenib for eligible high-risk BRAF mutation-positive patients in the adjuvant treatment of melanoma after surgical resection. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

Condition or disease Intervention/treatment
Melanoma Adjuvant Drug: Dabrafenib and Trametinib Drug: Dabrafenib Drug: Trametinib

Detailed Description:

The requesting Treating Physician submitted a request for access to drug (often referred to as Compassionate Use) to Novartis which was reviewed and approved by the medical team experienced with the drug and indication.

This program will provide access to patients until:

  • All participating countries have received marketing authorization and product is commercially available and accessible to all participating patient(s) or
  • Alternative treatment options are available and/or
  • In case of changes in the safety profile or a lack of overall efficacy of the product.

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: Managed Access Program (MAP) to Provide Access to Trametinib and Dabrafenib Combination Therapy in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection

Intervention Details:
  • Drug: Dabrafenib and Trametinib

    The starting dose of the combination treatment will be administered as follows:

    • Dabrafenib, 150 mg, twice daily (BID);
    • Trametinib, 2.0 mg, once daily (QD)
  • Drug: Dabrafenib
    If administration of dabrafenib is interrupted or permanently discontinued, administration of trametinib may continue.
  • Drug: Trametinib
    If administration of trametinib is interrupted or permanently discontinued, administration of dabrafenib may be continued.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Has or is willing to give consent to the Treating Physician in accordance with the local regulatory requirements.
  2. Has the following diagnosis: Completely resected (R0) histologically confirmed high-risk (stage III) cutaneous melanoma with confirmed BRAF V600E/K activating mutation.

    Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible. Patients with an unknown primary melanoma are not eligible.

  3. All clinical trials that the patient might qualify for have been ruled out.
  4. Is receiving care at a clinical site with a Treating Physician who has experience with administering investigational agents for patients with this condition, or the patient is willing and/or able to travel to a site and receive treatment under the guidance of physician with this experience.
  5. Is able to retain oral medication and swallow tablets/capsules (appropriate exceptions allowed for patients who are unable to swallow tablets/capsules - this is subject to availability of alternative (liquid) oral formulations).
  6. Does not require treatment with any (other) anti-cancer medication while on the Managed Access Program (exceptions might be allowed and are subject to individual evaluation).
  7. For patients with active brain metastases: the patient does not require or is ineligible for immediate local treatment.
  8. Is not eligible for participation in any of the IMP's ongoing clinical trials or has recently completed a clinical trial that has been terminated and, after considering other options (e.g., trial extensions, amendments, etc.), the clinical team has determined that treatment is necessary and there are no other feasible alternatives for the patient.

Exclusion Criteria:

  1. Uveal or mucosal melanoma.
  2. Evidence of metastatic disease including in-transit metastasis.
  3. Female who is pregnant or nursing (patient must discontinue nursing in order to enroll in the program).
  4. Patients who have any lab abnormalities
  5. Patients who have received prior therapy with a BRAF inhibitor other than dabrafenib.
  6. Current evidence of cardiovascular risk.
  7. Known history for testing positive for Human Immunodeficiency Virus (HIV).
  8. Not able to understand and to comply with treatment instructions and requirements.

Other protocol-defined inclusion/exclusion criteria may apply at the end.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04544202

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Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT04544202    
Other Study ID Numbers: CDRB436F2001CM
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Malignant skin cancer
Skin cancer
Stage III melanoma
Surgical resection
Compassionate Use
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action