Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy

Launched by SAINT PETERSBURG STATE UNIVERSITY, RUSSIA · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment approach called "Rechallenge" for patients with a specific type of cancer known as BRAF-positive anaplastic thyroid cancer. After these patients have already been treated with two medications, dabrafenib and trametinib, and their cancer has progressed, the study will see if giving these medications again can be effective. The researchers want to understand how safe this repeated treatment is and whether it can help improve outcomes for these patients.

To be eligible for this trial, patients need to be at least 18 years old and have been diagnosed with anaplastic thyroid cancer that has a specific genetic mutation (called BRAF V600). They should have already shown some response to the initial treatment with dabrafenib and trametinib but later experienced progression of their cancer. Participants will undergo the targeted therapy again and will be closely monitored for their health and any side effects. It’s important to note that certain conditions, like pregnancy and previous severe reactions to the study medications, may prevent someone from participating.

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Eligibility criteria

• Inclusion Criteria:
• • immunohistochemically verified anaplastic thyroid cancer;
• • presence of a mutation in the BRAF V600 gene;
• • documented progression during targeted therapy with dabrafenib + trametinib;
• • documented progression during at least one line of chemotherapy (use of taxane-containing chemotherapy is mandatory);
• • age ≥ 18 years;
• • ECOG performance status 0-2;
• • adequate function of internal organs and bone marrow;
• • ability to give written informed consent.
• Exclusion Criteria:
• • primary resistance (absence of initial clinical and radiological response to therapy with dabrafenib and trametinib (response criteria - primary objective response according to RECIST 1.1 criteria and duration of response of at least 3 months);
• • absence of taxane-containing chemotherapy as second or third line;
• • contraindication to taking any of the study drugs (including severe toxicity that occurred during a previous dose, which led to discontinuation of treatment);
• • patients with unsatisfactory functional status (ECOG 3-4);
• • pregnancy and breastfeeding.