November 20, 2018
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November 27, 2018
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November 13, 2023
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April 2, 2019
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July 2024 (Final data collection date for primary outcome measure)
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- Progression-free survival rate at 6 months [ Time Frame: 6 months ]
Percentage of patients without progression of disease at month 6, according RECIST 1.1 criteria.
- Overall survival rate at 6 months [ Time Frame: 6 months ]
Percentage of patients alive at month 6 from first dose of treatment.
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- Progression-free survival rate at 6 months [ Time Frame: 6 months ]
Percentage of patients without progression of disease at month 6, according RECIST 1.1 criteria.
- Overall survival rate at 6 months [ Time Frame: 6 months ]
Percentage of patients alive at 2-years from first dose of treatment.
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- Overall response rate (ORR) [ Time Frame: 42 months ]
Response to treatment according to RECIST 1.1 criteria or iRECIST 1.1 criteria
- Duration of response (DoR) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months ]
Length of time between start of treatment and date of evidenced response and progression of disease according irRECIST or RECIST 1.1 criteria, or death
- Median progression-free survival [ Time Frame: 42 months ]
Length of time between date of evidenced response and progression of disease according irRECIST or RECIST 1.1 criteria, or death, or death
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 42 months ]
Number and type of adverse events reported throughout the study period
- Median Overall Survival [ Time Frame: 42 months ]
Length of time between start of treatment and death
- Response status after start of study treatment [ Time Frame: 6 and 12 months after start of the study treatment ]
According irRECIST/RECIST
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- Overall response rate (ORR) [ Time Frame: 42 months ]
Response to treatment according to RECIST 1.1 criteria or iRECIST 1.1 criteria
- Duration of response according [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months ]
Length of time between start of treatment and date of evidenced response and progression of disease or death
- Median progression-free survival [ Time Frame: 42 months ]
Length of time between date of evidenced response and progression of disease or death
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 42 months ]
Number and type of adverse events reported throughout the study period
- Median Overall Survival [ Time Frame: 42 months ]
Length of time between start of treatment and death
- Response status after start of study treatment [ Time Frame: 6 and 12 months after start of the study treatment ]
According irRECIST/RECIST
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Not Provided
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Not Provided
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Durvalumab Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial
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A Phase II Study of Durvalumab (MEDI4736) Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma - The DUTHY Trial
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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.
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Not Provided
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Interventional
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Phase 2
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Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description:
- Cohort 1: Advanced, radioiodine-refractory differentiated thyroid carcinoma, including papillary, follicular, Hürtle. 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) Primary Purpose: Treatment
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- Metastatic Thyroid Papillary Carcinoma
- Metastatic Thyroid Follicular Carcinoma
- Metastatic Thyroid Cancer
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- Drug: Durvalumab
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.
Other Name: MEDI4736
- Drug: Tremelimumab
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.
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Experimental: Durvalumab + Tremelimumab
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.
Interventions:
- Drug: Durvalumab
- Drug: Tremelimumab
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Not Provided
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Active, not recruiting
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79
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46
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December 2024
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July 2024 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
Exclusion Criteria:
- 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).
- 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.
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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Spain
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NCT03753919
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GETNE-T1812 2018-001066-42 ( EudraCT Number )
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Yes
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Studies a U.S. FDA-regulated Drug Product: |
No |
Studies a U.S. FDA-regulated Device Product: |
No |
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Plan to Share IPD: |
Undecided |
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Grupo Espanol de Tumores Neuroendocrinos
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Same as current
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Grupo Espanol de Tumores Neuroendocrinos
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Same as current
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MFAR
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Study Chair: |
Jaume Capdevila, M.D., Ph.D. |
Hospital Universitari Vall d'Hebron, Barcelona |
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Grupo Espanol de Tumores Neuroendocrinos
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November 2023
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