Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF MutationPhase 2MERAIODENCT03244956
Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer
A Phase 2 study testing Trametinib, Dabrafenib and 131I in people with Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation
- What is being tested?
- Trametinib, Dabrafenib and 131I
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 27 Dec 2017to 15 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with thyroid carcinoma of follicular origin (papillary, follicular or poorly differentiated and their respective variants)
- Known positive RAS (NRAS or KRAS or HRAS) or BRAFV600E or K601E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples sent for central testing or on a biopsy sample sent for central testing).
- Radioiodine-refractory disease defined by at least one of the following item:
- Distant metastasis without radioiodine uptake on a posttherapeutic radioactive scan
- Distant metastasis disclosing RECIST progression within 12 months after a RAI treatment
- Measurable disease with at least one lesion >/= 1.0 cm in the longest diameter for a non-lymph node or >/= 1.5 cm in the short axis for a lymph node, measured with spiral computed tomography (CT) without iv contrast injection or magnetic resonance imaging (MRI) according to RECIST 1.1
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- Progressive disease according to RECIST 1.1 criteria within 18 months prior initiation of treatment
- Absence of metastatic lesion > 30mm
- Previous cumulated activity of radioactive iodine ≤ 600 mCi (22.2GBq)
- Patients may have received prior treatment with either 1 line of Tyrosine Kinase Inhibitor or 1 line of immunotherapy (excluding anti BRAF or anti MEK treatment such as sorafenib, dabrafenib, trametinib and selumitinib) but should be off treatment within 28 days prior to treatment start
- 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 Cycle 1/Day 1
- Creatinine clearance ≥50 mL/min according to the Cockcroft and Gault formula
- Adequate bone marrow function with :
- 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
- Adequate liver function with:
- 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).
- Males or females age ≥ 18 years at the time of informed consent
- 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. Sexually active women of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 12 months after the last study treatment administration. Sexually active males patients must agree to use condom during the study and for at least 12 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.
- In case of previous external beam radiation, all radiation therapy related toxicities must have resolved to < Grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE v 4.0), except alopecia and infertility.
- Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
- Patient affiliated to a social security regimen or beneficiary of the same
Who cannot join
- Undifferentiated or Medullary (MTC) carcinoma of the thyroid
- Brain metastases (including asymptomatic brain metastases)
- Major surgery within 4 weeks prior to the first dose of drug
- Subjects having > 1 + proteinuria on urine dipstick testing will undergo 24 h urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥ 1 g/24 h will be ineligible.
- Need for locoregional treatment such as surgery, external beam radiation or thermoablation at inclusion
- Prior RAI therapy < 6 months prior initiation of treatment
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- External beam radiation < 4 weeks prior initiation of treatment
- Iodine contamination defined by a urine ioduria ≥ 50 μg/dl
- 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 drug, or cardiac arrhythmia associated with significant cardiovascular impairment and uncontrolled hypertension
- 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 drug and any other active bleeding, coagulopathy or pathologic condition that would confer a high risk of bleeding.
- Active infection requiring systemic therapy
- Active malignancy (except for DTC, or definitively treated melanoma insitu, 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 8 weeks prior enrolment
- Previous history of retinal vein occlusion
- Previous history of central serious retinopathy
- Known hypersensitivity to the study drugs or to any of the excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Selective MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors Associated With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer With RAS or BRAFV600E Mutation
This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation.
- Conditions
- Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation
- Being tested
- Trametinib, Dabrafenib, 131I, rhTSH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrametinibDrug
2mg daily for a maximum of 6 weeks of treatment
DabrafenibDrug
150mg twice daily
131IRadiation
5.5 GBq
rhTSHDrug
0.9mg on two consecutive days after 35 days of treatment
| Study group | Role | What they receive |
|---|---|---|
| patients with RAS mutation | Experimental | Not described Receives: Drug: Trametinib; Radiation: 131I; Drug: rhTSH |
| patients with BRAFV600E mutation | Experimental | Not described Receives: Drug: Trametinib; Drug: Dabrafenib; Radiation: 131I; Drug: rhTSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Propotion of patients with a best overall response of Complete Response (CR) or a Partial Response (PR)
Measured: Evaluated 6 months after the first dose of trametinib or trametinib and dabrafenib followed by RAI treatment in each arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start27 Dec 2017
- Primary completion23 May 2022
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF MutationStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244956
- Sponsor's protocol ID
- 2017-000742-21
- Other IDs
- 2017/2527, 2017
- Acronym
- MERAIODE
- Status last verified
- Mar 2026
- First submitted
- 7 Aug 2017
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anizan N, Pignard A, Borget I, Lamartina L, Schlumberger M, Broggio D, Leboulleux S, Lamart S. Lesional dosimetry in 131I refractory metastatic differentiated thyroid cancer with BRAFp.V600E or RAS mutation treated with trametinib +/- dabrafenib followed by radioactive iodine. Phys Med. 2026 May;145:105769. doi: 10.1016/j.ejmp.2026.105769. Epub 2026 Mar 19.
PubMed 41861727Leboulleux S, Benisvy D, Taieb D, Attard M, Bournaud C, Terroir-Cassou-Mounat M, Lacroix L, Anizan N, Schiazza A, Garcia ME, Ghuzlan AA, Lamartina L, Schlumberger M, Godbert Y, Borget I. MERAIODE: A Phase II Redifferentiation Trial with Trametinib and 131I in Metastatic Radioactive Iodine Refractory RAS Mutated Differentiated Thyroid Cancer. Thyroid. 2023 Sep;33(9):1124-1129. doi: 10.1089/thy.2023.0240. Epub 2023 Jul 26. No abstract available.
PubMed 37350119
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Selective MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors Associated With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer With RAS or BRAFV600E Mutation
- ClinicalTrials.gov ID
- NCT03244956
- Acronym / sponsor ID
- MERAIODE / 2017-000742-21
- Conditions
- Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation
| Arm | Type | Receives |
|---|---|---|
| patients with RAS mutation | Experimental | Drug: Trametinib, Radiation: 131I, Drug: rhTSH |
| patients with BRAFV600E mutation | Experimental | Drug: Trametinib, Drug: Dabrafenib, Radiation: 131I, Drug: rhTSH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients with thyroid carcinoma of follicular origin (papillary, follicular or poorly differentiated and their respective variants)
- Known positive RAS (NRAS or KRAS or HRAS) or BRAFV600E or K601E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples sent for central testing or on a biopsy sample sent for central testing).
- Radioiodine-refractory disease defined by at least one of the following item:
- Measurable disease with at least one lesion >/= 1.0 cm in the longest diameter for a non-lymph node or >/= 1.5 cm in the short axis for a lymph node, measured with spiral computed tomography (CT) without iv contrast injection or magnetic resonance imaging (MRI) according to RECIST 1.1
- Progressive disease according to RECIST 1.1 criteria within 18 months prior initiation of treatment
Key exclusion criteria (20 listed)
- Undifferentiated or Medullary (MTC) carcinoma of the thyroid
- Brain metastases (including asymptomatic brain metastases)
- Major surgery within 4 weeks prior to the first dose of drug
- Subjects having > 1 + proteinuria on urine dipstick testing will undergo 24 h urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥ 1 g/24 h will be ineligible.
- Need for locoregional treatment such as surgery, external beam radiation or thermoablation at inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trametinib2mg daily for a maximum of 6 weeks of treatment | Drug | patients with BRAFV600E mutation, patients with RAS mutation |
| Dabrafenib150mg twice daily | Drug | patients with BRAFV600E mutation |
| 131I5.5 GBq | Radiation | patients with BRAFV600E mutation, patients with RAS mutation |
| rhTSH0.9mg on two consecutive days after 35 days of treatment | Drug | patients with BRAFV600E mutation, patients with RAS mutation |
Primary outcome
Objective Response Rate (ORR)
Time frame: Evaluated 6 months after the first dose of trametinib or trametinib and dabrafenib followed by RAI treatment in each arms
Propotion of patients with a best overall response of Complete Response (CR) or a Partial Response (PR)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 41861727Anizan N, Pignard A, Borget I, Lamartina L, Schlumberger M, Broggio D, Leboulleux S, Lamart S. Lesional dosimetry in 131I refractory metastatic differentiated thyroid cancer with BRAFp.V600E or RAS mutation treated with trametinib +/- dabrafenib followed by radioactive iodine. Phys Med. 2026 May;145:105769. doi: 10.1016/j.ejmp.2026.105769. Epub 2026 Mar 19.
- Derived from this study: PubMed 37350119Leboulleux S, Benisvy D, Taieb D, Attard M, Bournaud C, Terroir-Cassou-Mounat M, Lacroix L, Anizan N, Schiazza A, Garcia ME, Ghuzlan AA, Lamartina L, Schlumberger M, Godbert Y, Borget I. MERAIODE: A Phase II Redifferentiation Trial with Trametinib and 131I in Metastatic Radioactive Iodine Refractory RAS Mutated Differentiated Thyroid Cancer. Thyroid. 2023 Sep;33(9):1124-1129. doi: 10.1089/thy.2023.0240. Epub 2023 Jul 26. No abstract available.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trametinib, Dabrafenib and 131I in people with Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Evaluated 6 months after the first dose of trametinib or trametinib and dabrafenib followed by RAI treatment in each arms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03244956, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.