Trial · NCT03753919
Durvalumab Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial
NCT03753919, Phase 2, Terminated, Grupo Espanol de Tumores Neuroendocrinos; results first posted 2026-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Durvalumab Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial. Trials, record NCT03753919. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03753919
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Durvalumab Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial
- NCT number
- NCT03753919
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 79 participants, actual
- Lead sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Conditions
- Metastatic Thyroid Papillary Carcinoma, Metastatic Thyroid Follicular Carcinoma, Metastatic Thyroid Cancer
- Interventions
- Durvalumab, Tremelimumab
- First posted
- 2018-11-27
- Last updated
- 2026-03-11
- Other registries' IDs
- eudract:2018-001066-42
- Results first posted
- 2026-03-11
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival Rate at 6 Months | 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). |
| Primary | Overall Survival Rate at 6 Months | 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. |
| Secondary | Overall Survival, Median | Throughout the trial period, with a following up to 4 years from the start of treatment | 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 |
| Secondary | Overall Survival Rate at 18 Months | Throughout the trial period, up to 18 months from first dose of treatment. | Percentage of patients alive at month 18 from first dose of treatment. |
| Secondary | Progression-free Survival (PFS), Median | Throughout the trial period, a median follow-up period 14 months from the start of treatment | 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. |
| Secondary | Progression-free Survival Rate at 18 Months | Throughout the study period, up to 18 months from start of treatment | 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). |
| Secondary | Overall Response Rate (ORR) | Through study completion, average 1 year | 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 |
| Secondary | Overall Response (OR) Best Response According to RECIST 1.1 | Throughout the trial period, with a following up to 4 years from the start of treatment | 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. |
| Secondary | Overall Response (OR) Best Response According irRecist Criteria | Throughout the trial period, with a following up to 4 years from the start of treatment | Defined as patients who achieved partial response (PR) or complete response (CR) as best response according to irRecist criteria. |
| Secondary | Duration of Response (DoR) Median RECIST 1.1 Criteria | Through study period, assessed up to 4 years | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival Rate at 6 Months | Throughout the study period, up to 6 months from start of treatment | Patients with progressive, refractory advanced thyroid carcinoma | percentage of patients | NUMBER |
| PRIMARY | Overall Survival Rate at 6 Months | Throughout the trial period, up to 6 months from first dose of treatment. | Patients with progressive, refractory advanced thyroid carcinoma | percentage of patients | NUMBER |
| SECONDARY | Overall Survival, Median | Throughout the trial period, with a following up to 4 years from the start of treatment | Patients with progressive, refractory advanced thyroid carcinoma | months | MEDIAN |
| SECONDARY | Overall Survival Rate at 18 Months | Throughout the trial period, up to 18 months from first dose of treatment. | Patients with progressive, refractory advanced thyroid carcinoma | percentage of patients | NUMBER |
| SECONDARY | Progression-free Survival (PFS), Median | Throughout the trial period, a median follow-up period 14 months from the start of treatment | Patients with progressive, refractory advanced thyroid carcinoma | months | MEDIAN |
| SECONDARY | Progression-free Survival Rate at 18 Months | Throughout the study period, up to 18 months from start of treatment | Patients with progressive, refractory advanced thyroid carcinoma | percentage of patients | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Through study completion, average 1 year | Patients with progressive, refractory advanced thyroid carcinoma | percentage of patients | NUMBER |
| SECONDARY | Overall Response (OR) Best Response According to RECIST 1.1 | Throughout the trial period, with a following up to 4 years from the start of treatment | Patients with progressive, refractory advanced thyroid carcinoma | percentage of patients | NUMBER |
| SECONDARY | Overall Response (OR) Best Response According irRecist Criteria | Throughout the trial period, with a following up to 4 years from the start of treatment | Patients with progressive, refractory advanced thyroid carcinoma | percentage of patients | NUMBER |
| SECONDARY | Duration of Response (DoR) Median RECIST 1.1 Criteria | Through study period, assessed up to 4 years | Patients with progressive, refractory advanced thyroid carcinoma | months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival Rate at 6 Months | COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC) | 32.4 | 95% Confidence Interval 20.4 to 51.6 | percentage of patients | |
| Progression-free Survival Rate at 6 Months | COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC) | 40.9 | 95% Confidence Interval 26.3 to 63.6 | percentage of patients | |
| Progression-free Survival Rate at 6 Months | COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC) | 33.3 | 95% Confidence Interval 15.0 to 74.2 | percentage of patients | |
| Overall Survival Rate at 6 Months | COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC) | 70.3 | 95% Confidence Interval 56.7 to 86.7 | percentage of patients | |
| Overall Survival Rate at 6 Months | COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC) | 96.6 | 95% Confidence Interval 90.1 to 100 | percentage of patients | |
| Overall Survival Rate at 6 Months | COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC) | 65.6 | 95% Confidence Interval 43.2 to 99.8 | percentage of patients | |
| Overall Survival, Median | COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC) | 13.8 | 95% Confidence Interval 9.4 to 32.8 | months | |
| Overall Survival, Median | COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC) | 35.5 | 95% Confidence Interval 30.1 to NA | months | |
| Overall Survival, Median | COHORT 3: Advanced Anaplastic Thyroid Carcinoma (ATC) | 13.8 | 95% Confidence Interval 5.7 to NA | months | |
| Overall Survival Rate at 18 Months | COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC) | 41.5 | 95% Confidence Interval 28.0 to 61.4 | percentage of patients |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC) | 37 | |
| Overall Study | STARTED | COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC) | 30 | |
| Overall Study | STARTED | COHORT 3: Advanced Anaplastic Thyroid Cancer (ATC) | 12 | |
| Overall Study | COMPLETED | COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC) | 37 | |
| Overall Study | COMPLETED | COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC) | 30 | |
| Overall Study | COMPLETED | COHORT 3: Advanced Anaplastic Thyroid Cancer (ATC) | 12 | |
| Overall Study | NOT COMPLETED | COHORT 1: Advanced, Radioiodine-refractory Differentiated Thyroid Carcinoma (DTC) | 0 | |
| Overall Study | NOT COMPLETED | COHORT 2: Advanced Medullary Thyroid Carcinoma (MTC) | 0 | |
| Overall Study | NOT COMPLETED | COHORT 3: Advanced Anaplastic Thyroid Cancer (ATC) | 0 |
Source ClinicalTrials.gov
Adverse events552
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | COHORT 1: Durvalumab + Tremelimumab | 16 | 37 | 16 |
| other | Fatigue | General disorders | COHORT 1: Durvalumab Monotherapy | 0 | 26 | 0 |
| other | Fatigue | General disorders | COHORT 2: Durvalumab + Tremelimumab | 10 | 30 | 10 |
| other | Fatigue | General disorders | COHORT 2: Durvalumab Monotherapy | 0 | 25 | 0 |
| other | Fatigue | General disorders | COHORT 3: Durvalumab + Tremelimumab | 7 | 12 | 7 |
| other | Fatigue | General disorders | COHORT 3: Durvalumab Monotherapy | 0 | 10 | 0 |
| other | Pruritus | Skin and subcutaneous tissue disorders | COHORT 1: Durvalumab + Tremelimumab | 10 | 37 | 10 |
| other | Pruritus | Skin and subcutaneous tissue disorders | COHORT 1: Durvalumab Monotherapy | 0 | 26 | 0 |
| other | Pruritus | Skin and subcutaneous tissue disorders | COHORT 2: Durvalumab + Tremelimumab | 14 | 30 | 14 |
| other | Pruritus | Skin and subcutaneous tissue disorders | COHORT 2: Durvalumab Monotherapy | 0 | 25 | 0 |
1 to 10 of 552Source ClinicalTrials.gov
See all 552 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | COHORT 1: Durvalumab + Tremelimumab | 11 | 37 |
| Total, all-cause mortality | COHORT 1: Durvalumab Monotherapy | 18 | 26 |
| Total, all-cause mortality | COHORT 2: Durvalumab + Tremelimumab | 1 | 30 |
| Total, all-cause mortality | COHORT 2: Durvalumab Monotherapy | 10 | 25 |
| Total, all-cause mortality | COHORT 3: Durvalumab + Tremelimumab | 2 | 12 |
| Total, all-cause mortality | COHORT 3: Durvalumab Monotherapy | 7 | 10 |
| Total, other adverse events | COHORT 1: Durvalumab + Tremelimumab | 35 | 37 |
| Total, other adverse events | COHORT 1: Durvalumab Monotherapy | 0 | 26 |
| Total, other adverse events | COHORT 2: Durvalumab + Tremelimumab | 30 | 30 |
| Total, other adverse events | COHORT 2: Durvalumab Monotherapy | 0 | 25 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41935063 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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