Phase 2 Thyroid Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

This trial has four groups (called subprotocols A, B, C, and D). The criteria below are organised by group.

Subprotocol A (Solid tumors or brain tumors with a BRAF gene fusion):

• People aged 8 or older who weigh at least 25 kg (about 55 lbs), of any sex
• People who have been diagnosed with a solid tumor or a primary brain tumor, confirmed by laboratory testing of tissue
• People whose tumor (or a blood sample) has tested positive for a specific genetic change called a BRAF gene fusion, detected by an approved DNA or RNA test
• People who have a stored tissue sample available that meets the study's requirements
• People who agree to provide scan results from before the study starts, so the research team can track how the tumor has been changing
• People who have already received all standard treatment options, cannot tolerate available treatments, or whose doctor has determined that standard treatment is not appropriate for them
• People whose side effects from any previous cancer treatments (such as chemotherapy, radiation, or surgery) have either fully resolved or returned to their baseline level

Subprotocol B (Primary brain tumors with a BRAF V600E mutation):

• People aged 8 or older who weigh at least 25 kg, of any sex
• Adults (aged 18 and over) who have been diagnosed with a Grade 1–4 brain tumor of a specific type, including glioblastoma, astrocytoma, pilocytic astrocytoma, gliosarcoma, oligodendroglioma, ganglioglioma, or related tumors
• Children and teenagers (aged 8–17) who have a Grade 3 or 4 brain tumor of a specific type, including those who previously had a lower-grade brain tumor that has since progressed
• People whose tumor cannot be surgically removed, has spread locally, or has spread to other parts of the body, and who have already received radiation and/or chemotherapy, cannot tolerate available treatments, or whose doctor has determined standard treatment is not appropriate (note: some patients with Grade 3 or 4 tumors for whom chemotherapy or radiation is not standard may still be considered eligible — confirm with trial site)
• People whose tumor (or a blood sample) has tested positive for a specific genetic change called a BRAF V600E mutation, confirmed by an approved laboratory test
• People who have a stored tissue sample available, or are willing to have a fresh biopsy taken if no stored sample is available
• People who agree to provide scan results from before the study starts
• People who have measurable disease visible on approved imaging scans, as assessed by an independent review team
• People whose side effects from previous treatments have fully resolved or returned to their baseline level
• People who are taking steroid medications (such as dexamethasone) and have been on a stable or reducing dose of no more than 8 mg per day for at least 7 days before starting the study treatment

Subprotocol C (Rare solid tumors with a BRAF V600E mutation):

• People aged 8 or older who weigh at least 25 kg, of any sex
• People who have been diagnosed with a rare solid tumor (not a brain tumor) that has a BRAF V600E genetic change, and whose tumor cannot be surgically removed, has spread locally, or has spread to other parts of the body
• People whose disease is measurable on a CT scan, MRI, or physical examination
• People whose tumor (or a blood sample) has tested positive for the BRAF V600E mutation using an approved test
• People who have a stored tissue sample available that meets the study's requirements
• People who agree to provide scan results from before the study starts
• People who have already received all standard treatment options, cannot tolerate available treatments, or whose doctor has determined that standard treatment is not appropriate

Subprotocol D (Solid tumors with a BRAF V600E mutation not covered by the other groups):

• People aged 8 or older who weigh at least 25 kg, of any sex
• People who have been diagnosed with a solid tumor carrying a BRAF V600E genetic change and who do not meet the criteria for Subprotocols A, B, or C
• People whose disease is measurable on a CT scan, MRI, or physical examination
• People whose tumor (or blood sample) shows evidence of the BRAF V600E mutation on genetic testing
• People who agree to provide a tumor biopsy sample
• People who are willing to follow the procedures involved in the heart monitoring (ECG) part of the study
• People whose side effects from any previous cancer treatments have fully resolved or returned to their baseline level

Who may not be able to join:

Subprotocol A:

• People who have previously been treated with certain BRAF-targeting drugs (RAF/BRAF inhibitors that work on a specific class of BRAF changes called Class 2) for advanced or metastatic disease
• People who have previously received a type of cancer drug called a MEK inhibitor
• People whose cancer also has an activating RAS gene mutation (at any point in their history)
• People with another serious ongoing illness that would make it difficult to follow the study requirements
• People with HIV infection in most circumstances (exceptions may apply — confirm with trial site)
• People with significant digestive system problems that could affect how the study drugs are absorbed, such as severe nausea, vomiting, diarrhoea, ulcerative conditions, or prior removal of part of the small bowel
• People who had specific liver-related side effects (Grade 2 or higher changes in certain liver markers — AST, ALT, GGT, or bilirubin) caused by a prior type of immunotherapy called immune checkpoint inhibitors, even if those effects have since resolved

Subprotocol B:

• People who have previously been treated with BRAF, ERK, or MEK inhibitor drugs
• People who are known or suspected to have a condition called neurofibromatosis type 1 (NF-1), or who have related genetic changes in the RAS pathway
• People with another serious ongoing illness that would make it difficult to follow the study requirements
• People with an active infection that requires treatment with systemic (whole-body) medications
• People with HIV infection in most circumstances (exceptions may apply — confirm with trial site)
• People with significant digestive system problems that could affect how the study drug is absorbed
• People who had specific liver-related side effects (Grade 2 or higher changes in liver markers — AST, ALT, GGT, or bilirubin) caused by prior immune checkpoint inhibitor therapy, even if resolved

Subprotocol C:

• People diagnosed with colorectal cancer (adenocarcinoma type) or pancreatic ductal adenocarcinoma (note: neuroendocrine or acinar tumors of the pancreas may still be eligible — confirm with trial site)
• People diagnosed with BRAF V600E-mutated skin melanoma, papillary thyroid cancer, or a type of lung cancer called NSCLC
• People whose cancer has spread to the brain
• People who have previously been treated with BRAF, ERK, or MEK inhibitor drugs (some exceptions may apply for certain cancer types such as low-grade serous or borderline ovarian cancer — confirm with trial site)
• People known or suspected to have neurofibromatosis type 1 (NF-1), or related RAS pathway genetic changes
• People with prostate, breast, or gynaecologic cancers that are known to have specific hormone receptor mutations (AR-V7 or ESR1)
• People with another serious ongoing illness that would make it difficult to follow the study requirements
• People with an active infection requiring systemic treatment
• People with HIV infection in most circumstances (exceptions may apply — confirm with trial site)

Subprotocol D:

• People known or suspected to have neurofibromatosis type 1 (NF-1), RAS pathway genetic changes, or other additional driving genetic mutations in their cancer
• People with a non-brain solid tumor that has spread to the brain
• People with another serious ongoing illness that would make it difficult to follow the study requirements
• People with an active infection requiring systemic treatment
• People with HIV infection in most circumstances (exceptions may apply — confirm with trial site)
• People who are currently taking, or expect to need, medications known to carry a risk of causing a specific type of heart rhythm problem (QT prolongation and Torsades de Pointes)
• People participating in the heart monitoring (ECG) part of the study who have a history of heart disease, heart surgery, poorly controlled high blood pressure (systolic above 160 mmHg), abnormal heart rhythm measurements (QTc), or other significant heart tracing abnormalities

Important: Always verify eligibility with the trial site directly before applying.