Metastatic Thyroid Papillary CarcinomaPhase 2DUTHYNCT03753919
Durvalumab Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial
A Phase 2 study testing Durvalumab and Tremelimumab in people with Metastatic Thyroid Papillary Carcinoma and Metastatic Thyroid Follicular Carcinoma, run by Grupo Espanol de Tumores Neuroendocrinos at 15 sites in Spain.
Trial summary
This is a prospective, multi-centre, open label, stratified, exploratory phase II study evaluating the efficacy and safety of durvalumab plus tremelimumab in different cohorts of patients with thyroid cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Thyroid Papillary Carcinoma, Metastatic Thyroid Follicular Carcinoma, Metastatic Thyroid Cancer
- What is being tested?
- Durvalumab and Tremelimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 15 sitesSpain
- Study dates
- 2 Apr 2019to 8 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Age ≥ 18 years at time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Body weight >30kg.
- Confirmed differentiated thyroid cancer (papillary, follicular, poorly differentiated and Hürthle cell), medullary thyroid cancer and anaplastic thyroid cancer.
- Available tumor and blood samples for translational research
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- Patients should meet one of the following criteria:
- Cohort 1: Patients with locally advanced or metastatic differentiated thyroid cancer (including the subtypes of papillary, follicular, poorly differentiated and Hürthle cell carcinoma) after disease progression on systemic therapy with MKIs. Patients could be recruited in the study after progression on Lenvatinib (regardless prior lines) or progression on at least two prior MKIs which may or not include Lenvatinib. No prior therapy with immune check point inhibitors is allowed. Patients with intolerable toxicity to MKIs that meet the prior inclusion criteria and experience disease progression by RECIST v1.1 after stopping therapy may be included.
- Cohort 2: Patients with locally advanced or metastatic medullary thyroid cancer after progression on systemic therapy with MKIs. Patients could be recruited in the study after progression to Vandetanib (regardless prior lines) or progression to at least two prior MKIs that may or not include Vandetanib. No prior therapy with immune check point inhibitors is allowed. Patients with intolerable toxicity to MKIs that meet the prior inclusion criteria and experience disease progression by RECIST v1.1 after stopping therapy may be included.
- Cohort 3: Patients with locally advanced or metastatic anaplastic thyroid cancer regardless of prior therapy. No prior therapy with immune check point inhibitors is allowed.
- No limitation of number of prior therapies.
- Life expectancy >3 months
- Adequate normal organ and marrow function as defined below: a) Haemoglobin ≥9.0 g/dL. b) Absolute neutrophil count (ANC) > 1500 per mm3. c) Platelet count ≥100,000 per mm3. d) Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician. e) AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal. f) Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre- menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: a) Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). b) Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Participation in another clinical study with an investigational product during the last 21 days.
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Any previous treatment with a PD1, PD-L1 or CTLA-4 inhibitor, including durvalumab and tremelimumab.
- Any previous treatment with immunotherapy, including combinations of immunotherapy and other anticancer or targeted agents.
- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction.
- Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection). b) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent. c) Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
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- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: a) Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. b) Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- History of allogenic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: a) Patients with vitiligo or alopecia. b) Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement. c) Any chronic skin condition that does not require systemic therapy. d) Patients without active disease in the last 5 years may be included but only after consultation with the study physician. e) Patients with celiac disease controlled by diet alone.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- History of another primary malignancy except for: a) Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence. b) Adequately treated non-melanoma skin cancer or lentigomaligna without evidence of disease. c) Adequately treated carcinoma in situ without evidence of disease.
- History of active primary immunodeficiency.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 90 days after the last dose of durvalumab monotherapy and 180 days for combined treatment with durvalumab and tremelimumab.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Hospital Clínic Barcelona
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Provincial de Castellón
Castellon, Valencia
Instituto Catalán de Oncología de Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
MD Anderson Cancer Center
Madrid, 28033
Hospital Clínico San Carlos
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario HM Sanchinarro
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Virgen de la Victoria
Málaga
Hospital General Universitario Morales Meseguer
Murcia
Clínica Universidad de Navarra
Pamplona
Instituto Valenciano de Oncología
Valencia, 46009
Complejo Hospitalario Universitario de Vigo (CHUVI)
Vigo, 36036
About this study
Official title: A Phase II Study of Durvalumab (MEDI4736) Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma - The DUTHY Trial
This is a prospective, multi-centre, open label, stratified, exploratory phase II study evaluating the efficacy and safety of durvalumab plus tremelimumab in different cohorts of patients with thyroid cancers.
- Conditions
- Metastatic Thyroid Papillary Carcinoma, Metastatic Thyroid Follicular Carcinoma, Metastatic Thyroid Cancer
- Being tested
- Durvalumab, Tremelimumab
- Medical subject headings
- Thyroid Cancer, Papillary, Adenocarcinoma, Follicular, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
Subjects will be allocated in each primary tumor cohort to receive durvalumab 1500 mg every 4 weeks (Q4W) plus tremelimumab 75 mg Q4W for up to 4 doses during the first 4 cycles of combined therapy. After the first 4 cycles (or before is tremelimumab is stopped due to toxicity), patients will continue to receive durvalumab 1500 mg Q4W until disease progression or unacceptable toxicity. Cycles are defined by 4 weeks or 28 days.
TremelimumabDrug
Subjects will be allocated in each primary tumor cohort to receive durvalumab 1500 mg every 4 weeks (Q4W) plus tremelimumab 75 mg Q4W for up to 4 doses during the first 4 cycles of combined therapy. After the first 4 cycles (or before is tremelimumab is stopped due to toxicity), patients will continue to receive durvalumab 1500 mg Q4W until disease progression or unacceptable toxicity. Cycles are defined by 4 weeks or 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab + Tremelimumab | Experimental | Durvalumab 1500 mg plus tremelimumab 75 mg every 4 weeks up to 4 cycles followed by durvalumab 1500 mg every 4 weeks until disease progression, unacceptable toxicity or patients' decision. Receives: Drug: Durvalumab; Drug: Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival Rate at 6 Months
6-months progression-free survival by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), which is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) at 24 weeks after durvalumab plus tremelimumab was started without observing disease progression or death at this time point.
Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression disease. For non-target lesions, CR: Disappearance of all non-target lesions; Non-CR/Non-PD: Persistence of one or more non-target lesion(s).
Measured: Throughout the study period, up to 6 months from start of treatment
Overall Survival Rate at 6 Months
Defined as percentage of patients alive at month 6 from first dose of treatment.
Measured: Throughout the trial period, up to 6 months from first dose of treatment.
Secondary outcomes (10)
Overall Survival, Median
Median OS, defined as the time from the start of treatment until death (patients without events were censored at the last follow-up). Estimated by Kaplan-Meier
Measured: Throughout the trial period, with a following up to 4 years from the start of treatment
Overall Survival Rate at 18 Months
Percentage of patients alive at month 18 from first dose of treatment.
Measured: Throughout the trial period, up to 18 months from first dose of treatment.
Progression-free Survival (PFS), Median
median PFS, defined as the time from the start of treatment until disease progression (PD) according to RECIST v1.1 or death (patients without events were censored at the last tumor assessment). Estimated by Kaplan-Meier.
Per RECIST v1.1, PD: for target lesions, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. For non-target lesions: unequivocal progression of existing non-target lesions or appearance of new lesions.
Measured: Throughout the trial period, a median follow-up period 14 months from the start of treatment
Progression-free Survival Rate at 18 Months
18-months progression-free survival by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), which is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) at 18 months after durvalumab plus tremelimumab was started without observing disease progression or death at this time point.
Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression disease. For non-target lesions, CR: Disappearance of all non-target lesions; Non-CR/Non-PD: Persistence of one or more non-target lesion(s).
Measured: Throughout the study period, up to 18 months from start of treatment
Overall Response Rate (ORR)
Defined as patients who achieved partial response (PR) or complete response (CR) as best response according to RECIST 1.1 criteria or iRECIST 1.1 criteria
Measured: Through study completion, average 1 year
Overall Response (OR) Best Response According to RECIST 1.1
Defined as patients who achieved partial response (PR) or complete response (CR) as best response according to RECIST 1.1 criteria Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For non-target lesions, CR: Disappearance of all non-target lesions.
Measured: Throughout the trial period, with a following up to 4 years from the start of treatment
Overall Response (OR) Best Response According irRecist Criteria
Defined as patients who achieved partial response (PR) or complete response (CR) as best response according to irRecist criteria.
Measured: Throughout the trial period, with a following up to 4 years from the start of treatment
Duration of Response (DoR) Median RECIST 1.1 Criteria
Defined as the time from the first PR/CR to disease progression or the last tumor assessment. DoR will be determined based on tumour assessment RECIST 1.1 criteria Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For non-target lesions, CR: Disappearance of all non-target lesions.
Measured: Through study period, assessed up to 4 years
Duration of Response (DoR) Median irRECIST Criteria
Defined as the time from the first PR/CR to disease progression or the last tumor assessment. DoR will be determined based on tumour assessment according to irRECIST criteria
Measured: Through study period, assessed up to 4 years
Percentage of Participants With Treatment-Related Adverse Events (TRAEs)
Percentage of patients who presented adverse events related with study treatment throughout the study period, Toxicity will be evaluated according NCI CTCAE v 5.0 criteria.
AEs and SAEs will be collected from the time of the patient signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab ± tremelimumab).
Measured: Throughout the study period, from start treatment up 90 days after the last dose, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start2 Apr 2019
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Why it stopped: In compliance with current legislation applicable to Clinical Trials, following the instructions of the Spanish Agency for Medicines and Health Products.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Thyroid Papillary CarcinomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- * Cohort 1: Advanced, radioiodine-refractory differentiated thyroid carcinoma, including papillary, follicular, Hürthle Cell and poorly-differentiated thyroid carcinoma (DTC). * Cohort 2: Advanced medullary thyroid carcinoma (MTC). * Cohort 3: Advanced anaplastic thyroid cancer (ATC).
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Sponsor type
- University, hospital or other
- Collaborators
- MFAR
- Responsible party
- Sponsor
- Investigators
- Jaume Capdevila, M.D., Ph.D., Study chair, Hospital Universitari Vall d'Hebron, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753919
- Sponsor's protocol ID
- GETNE-T1812
- Other IDs
- 2018-001066-42, 2018
- Acronym
- DUTHY
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2018
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Capdevila J, Hernando J, Molina-Cerillo J, Plana Serrahima M, Taberna Sanz M, Castelo B, Alvarez-Escola C, Carmona-Bayonas A, Ballester Navarro I, Iglesias L, Bover M, Garcia-Alvarez A, Lavernia J, Yaya Tur R, Ruiz S, Baste N, Lorenzo-Lorenzo I, Sanchez-Hernandez A, Sanz-Garcia E, Marquina G, Nuciforo P, Elguero B, Grande E, Alonso-Gordoa T. Durvalumab plus tremelimumab for the treatment of patients with progressive, refractory advanced thyroid carcinoma: the phase II GETNE-DUTHY trial. Nat Commun. 2026 Apr 4;17(1):4891. doi: 10.1038/s41467-026-71155-y.
PubMed 41935063
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Durvalumab (MEDI4736) Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma - The DUTHY Trial
- ClinicalTrials.gov ID
- NCT03753919
- Acronym / sponsor ID
- DUTHY / GETNE-T1812
- Conditions
- Metastatic Thyroid Papillary Carcinoma, Metastatic Thyroid Follicular Carcinoma, Metastatic Thyroid Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In compliance with current legislation applicable to Clinical Trials, following the instructions of the Spanish Agency for Medicines and Health Products.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Grupo Espanol de Tumores NeuroendocrinosUniversity, hospital or other
- Collaborators
- MFAR
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Posted 11 Mar 2026
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 prospective, multi-centre, open label, stratified, exploratory phase II study evaluating the efficacy and safety of durvalumab plus tremelimumab in different cohorts of patients with thyroid cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Cohort 1: Advanced, radioiodine-refractory differentiated thyroid carcinoma, including papillary, follicular, Hürthle Cell and poorly-differentiated thyroid carcinoma (DTC). * Cohort 2: Advanced medullary thyroid carcinoma (MTC). * Cohort 3: Advanced anaplastic thyroid cancer (ATC).
| Arm | Type | Receives |
|---|---|---|
| Durvalumab + Tremelimumab | Experimental | Drug: Durvalumab, Drug: TremelimumabDurvalumab 1500 mg plus tremelimumab 75 mg every 4 weeks up to 4 cycles followed by durvalumab 1500 mg every 4 weeks until disease progression, unacceptable toxicity or patients' decision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Age ≥ 18 years at time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Body weight >30kg.
- Confirmed differentiated thyroid cancer (papillary, follicular, poorly differentiated and Hürthle cell), medullary thyroid cancer and anaplastic thyroid cancer.
Key exclusion criteria (18 listed)
- Participation in another clinical study with an investigational product during the last 21 days.
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Any previous treatment with a PD1, PD-L1 or CTLA-4 inhibitor, including durvalumab and tremelimumab.
- Any previous treatment with immunotherapy, including combinations of immunotherapy and other anticancer or targeted agents.
- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction.
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 |
|---|---|---|
| DurvalumabAlso: MEDI4736Subjects will be allocated in each primary tumor cohort to receive durvalumab 1500 mg every 4 weeks (Q4W) plus tremelimumab 75 mg Q4W for up to 4 doses during the first 4 cycles of combined therapy. After the first 4 cycles (or before is tremelimumab is stopped due to toxicity), patients will continue to receive durvalumab 1500 mg Q4W until disease progression or unacceptable toxicity. Cycles are defined by 4 weeks or 28 days. | Drug | Durvalumab + Tremelimumab |
| TremelimumabSubjects will be allocated in each primary tumor cohort to receive durvalumab 1500 mg every 4 weeks (Q4W) plus tremelimumab 75 mg Q4W for up to 4 doses during the first 4 cycles of combined therapy. After the first 4 cycles (or before is tremelimumab is stopped due to toxicity), patients will continue to receive durvalumab 1500 mg Q4W until disease progression or unacceptable toxicity. Cycles are defined by 4 weeks or 28 days. | Drug | Durvalumab + Tremelimumab |
Primary outcome
Progression-free Survival Rate at 6 Months
Time frame: Throughout the study period, up to 6 months from start of treatment
6-months progression-free survival by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), which is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) at 24 weeks after durvalumab plus tremelimumab was started without observing disease progression or death at this time point. Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression disease. For non-target lesions, CR: Disappearance of all non-target lesions; Non-CR/Non-PD: Persistence of one or more non-target lesion(s).
Overall Survival Rate at 6 Months
Time frame: Throughout the trial period, up to 6 months from first dose of treatment.
Defined as percentage of patients alive at month 6 from first dose of treatment.
10 secondary outcomes
Overall Survival, Median
Time frame: Throughout the trial period, with a following up to 4 years from the start of treatment
Overall Survival Rate at 18 Months
Time frame: Throughout the trial period, up to 18 months from first dose of treatment.
Progression-free Survival (PFS), Median
Time frame: Throughout the trial period, a median follow-up period 14 months from the start of treatment
Progression-free Survival Rate at 18 Months
Time frame: Throughout the study period, up to 18 months from start of treatment
Overall Response Rate (ORR)
Time frame: Through study completion, average 1 year
Overall Response (OR) Best Response According to RECIST 1.1
Time frame: Throughout the trial period, with a following up to 4 years from the start of treatment
Overall Response (OR) Best Response According irRecist Criteria
Time frame: Throughout the trial period, with a following up to 4 years from the start of treatment
Duration of Response (DoR) Median RECIST 1.1 Criteria
Time frame: Through study period, assessed up to 4 years
Duration of Response (DoR) Median irRECIST Criteria
Time frame: Through study period, assessed up to 4 years
Percentage of Participants With Treatment-Related Adverse Events (TRAEs)
Time frame: Throughout the study period, from start treatment up 90 days after the last dose, up to 5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41935063Capdevila J, Hernando J, Molina-Cerillo J, Plana Serrahima M, Taberna Sanz M, Castelo B, Alvarez-Escola C, Carmona-Bayonas A, Ballester Navarro I, Iglesias L, Bover M, Garcia-Alvarez A, Lavernia J, Yaya Tur R, Ruiz S, Baste N, Lorenzo-Lorenzo I, Sanchez-Hernandez A, Sanz-Garcia E, Marquina G, Nuciforo P, Elguero B, Grande E, Alonso-Gordoa T. Durvalumab plus tremelimumab for the treatment of patients with progressive, refractory advanced thyroid carcinoma: the phase II GETNE-DUTHY trial. Nat Commun. 2026 Apr 4;17(1):4891. doi: 10.1038/s41467-026-71155-y.
- Individual participant dataSharing planned: Undecided
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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.
Jaume Capdevila, M.D., Ph.D. study chair
Hospital Universitari Vall d'Hebron, Barcelona
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab and Tremelimumab in people with Metastatic Thyroid Papillary Carcinoma and Metastatic Thyroid Follicular Carcinoma, run by Grupo Espanol de Tumores Neuroendocrinos at 15 sites in Spain.
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 15 inclusion and 18 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: stopped early, as of the sponsor's last update on 11 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 15 sites in Spain. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free Survival Rate at 6 Months (time frame: Throughout the study period, up to 6 months from start of treatment). The study lists 2 primary outcomes in all. 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 NCT03753919, which also lists 1 linked publication.
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 11 Mar 2026.