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New treatment option for Thyroid Gland Follicular Carcinoma
Official title Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation
ClinicalTrials.gov ID: NCT06440850
What this study is testing
What is Cobimetinib?
Cobimetinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for thyroid gland follicular carcinoma.
Also referred to as Cotellic, GDC-0973.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests how well vemurafenib and cobimetinib work in treating patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy. Vemurafenib and cobimetinib are used in patients whose cancer has a mutated (changed) form of a gene called BRAF.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented informed consent of the participant and/or legally authorized representative
- Willingness to be followed for about 14 months
- Males or females aged ≥ 18 years at the time of informed consent
- Patients with thyroid carcinoma of follicular origin (papillary, follicular or Hurthle cell)
- Known positive BRAFV600E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples...
You likely can't join if
- Prior RAI treatment
- Prior anti-BRAF, anti-MEK treatment such as sorafenib, dabrafenib, vemurafenib, encorafenib, binimetinib, cobimetinib, trametinib, d selumitinib and...
- Low to intermediate risk differentiated thyroid cancer (DTC) cases (not having the high-risk features as described above)
- RAI contraindication
- Undifferentiated or Medullary (MTC) carcinoma of the thyroid
- Major surgery within 4 weeks prior to the first dose of treatment
See the full eligibility criteria
Who can join
- Documented informed consent of the participant and/or legally authorized representative
- Willingness to be followed for about 14 months
- Males or females aged ≥ 18 years at the time of informed consent
- Patients with thyroid carcinoma of follicular origin (papillary, follicular or Hurthle cell)
- Known positive BRAFV600E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples or on a biopsy sample)
- High risk for recurrence according to the American Thyroid Association (ATA) guideline defined as having one or more of the features below:
- Gross extrathyroidal extension
- FTC with extensive vascular invasion (\> 4), although less likely to have BRAF mutation
- PTC with vascular invasion
- Advanced nodal disease of (any node \>3 cm, \> 4 nodes, or extra-nodal extension)
- BRAF+TERT promoter mutation
- Post op thyroglobulin (TG) suggestive of distant metastasis
- Distant metastatic sites (only for exploratory arm)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Blood pressure (BP) ≤ 140/90 mm Hg at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to treatment start
- Creatinine clearance ≥ 50 mL/min according to the Cockcroft and Gault formula
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100 x 109/L
- Normal blood coagulation function as evidenced by an International Normalized Ratio (INR) ≤ 1.5
- Bilirubin ≤ 1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome
- Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN if subject has liver metastases)
- Women of childbearing potential must have a negative urine or serum β-HCG pregnancy test within 7 days prior to the administration of the first study treatment
- Agreement by women of childbearing potential (WOCBP) and males of childbearing potential\ to use an effective\ \ method of birth control\ \ for at least 3 months prior to screening through 1 year of study follow-up.
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
- Effective birth control defined as hormonal and/or barrier contraception
- Non-English speaking persons and adults lacking capacity to consent are not excluded from participation
What rules you out
- Prior RAI treatment
- Prior anti-BRAF, anti-MEK treatment such as sorafenib, dabrafenib, vemurafenib, encorafenib, binimetinib, cobimetinib, trametinib, d selumitinib and other TKIs like, lenvatinib, sunitinib, axitinib, cabozantenib...
- Low to intermediate risk differentiated thyroid cancer (DTC) cases (not having the high-risk features as described above)
- RAI contraindication
- Undifferentiated or Medullary (MTC) carcinoma of the thyroid
- Major surgery within 4 weeks prior to the first dose of treatment
- people having \> 1 + proteinuria on urine dipstick testing will undergo 24 h urine collection for quantitative assessment of proteinuria. people with urine protein ≥ 1 g/24 h will be ineligible
- Need for locoregional treatment such as surgery, external beam radiation or thermoablation at inclusion
- External beam radiation, for thyroid cancer, \<4 weeks prior initiation of treatment
- Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of the drugs
- History of congestive heart failure greater or equal to than New York Heart association (NYHA) Class II, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of treatment, or cardiac...
- Electrocardiogram (ECG) with QT interval (QTc) interval ≥ 480 msec
- Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 2 months prior to the first dose of treatment and any other active bleeding, coagulopathy or pathologic condition that would confer a high risk of...
- Active infection requiring systemic therapy
- Active malignancy (except for DTC, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 months
- Any history of or concomitant medical condition that, in the opinion of the investigator, would compromise subject's ability to safely complete the protocol
- Females who are pregnant or breastfeeding
- Patients with an injection of radio-contrast agent within 12 weeks prior to enrollment (can be enrolled after 12 weeks)
- Previous history of retinal vein occlusion
- Previous history of central serious retinopathy
- Known hypersensitivity to the study drugs or to any of the excipients
- Any other condition (including psychosocial condition) that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Any other condition that would confound study results
- Noncompliance
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.