A phase II study of durvalumab (MEDI4736) plus tremelimumab for the treatment of patients withprogressive, refractory advanced thyroid carcinoma - The DUTHY trial - DUTHY trial

Spanish Group of Neuroendocrine Tumors (GETNE)0 sites84 target enrollmentNovember 23, 2018

ConditionsAdvanced, radioiodine-refractory differentiated thyroid carcinoma, including papillary,follicular, Hürtle Cell and poorly-differentiated thyroid carcinoma (DTC).Advanced medullary thyroid carcinoma (MTC)Advanced anaplastic thyroid cancer (ATC)MedDRA version: 20.0Level: PTClassification code 10076603Term: Poorly differentiated thyroid carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10002240Term: Anaplastic thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: PTClassification code 10016935Term: Follicular thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10027105Term: Medullary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033701Term: Papillary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: PTClassification code 10071027Term: Thyroid cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: PTClassification code 10071028Term: Thyroid cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsIMFINZI

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced, radioiodine-refractory differentiated thyroid carcinoma, including papillary,follicular, Hürtle Cell and poorly-differentiated thyroid carcinoma (DTC).Advanced medullary thyroid carcinoma (MTC)Advanced anaplastic thyroid cancer (ATC)
Sponsor: Spanish Group of Neuroendocrine Tumors (GETNE)
Enrollment: 84
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 23, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Spanish Group of Neuroendocrine Tumors (GETNE)

Eligibility Criteria

Inclusion Criteria

•? 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 1Body weight \>30kg.
•? Confirmed differentiated thyroid cancer (papillary, follicular, poorly differentiated and Hürtle cell), medullary thyroid cancer or anaplastic thyroid cancer.Available tumor and blood samples for translational research.
•? Patients should meet one of the following criteria:
•o 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.
•o 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.
•o 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.

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, except for intranasal and inhaled corticosteroids or systemic at physiological doses (\<10 mg/day of prednisone, or an equivalent). Exceptions:
•o Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).
•o Systemic corticosteroids at physiologic doses \<10 mg/day of prednisone or its equivalent.
•o Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
•? Any unresolved toxicity NCI CTCAE \=G2 from previous anticancer therapy, except for of alopecia, vitiligo, and lab values defined in the inclusion criteria: