Immunotherapy and Stereotactic Body Radiotherapy (SBRT) for Metastatic Anaplastic Thyroid Cancer

Conditions:Cancer, Endocrine
Therapuetic Areas:Endocrinology, Oncology
Age Range:18 - Any
Start Date:April 25, 2017
End Date:April 2020
Contact:Nancy Lee, MD

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A Pilot Study of Durvalumab (MEDI4736) With Tremelimumab in Combination With Image Guided Stereotactic Body Radiotherapy (SBRT) in the Treatment of Metastatic Anaplastic Thyroid Cancer

The purpose of this study is to test the safety of durvalumab (MEDI4736) and tremelimumab in
combination with radiation therapy and find out what effects, if any, this combination has on
people, and whether it improves overall survival.

Inclusion Criteria:

- Histopathologic confirmation of anaplastic thyroid cancer (or histopathologic report
consistent with anaplastic thyroid cancer) at Memorial Sloan Kettering Cancer Center
with clinical evidence of metastatic disease not curable by either surgery or
radiation therapy

- Age ≥ 18 years at time of study entry

- ECOG Performance Status of 0-2

- Adequate normal organ and marrow function as defined below:

- Hemoglobin ≥ 9.0 g/dL

- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (≥ 1500 per mm^3)

- Platelet count ≥ 100 x 109/L (≥100,000 per mm^3)

- Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not
apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent
hyperbilirubinaemia that is predominantly unconjugated in the absence of
hemolysis or hepatic pathology), who will be allowed only in consultation with
their physician

- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver
metastases are present, in which case it must be ≤ 5x ULN

- Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault
1976) or by 24-hour urine collection for determination of creatinine clearance:

- Males:

Creatinine CL (mL/min) = Weight (kg) x (140 - Age) . 72 x serum creatinine (mg/dL)

°Females: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine

- Female subjects must either be of non-reproductive potential (i.e., post-menopausal by
history: ≥51 years old and no menses for ≥ 1 year without an alternative medical
cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history
of bilateral oophorectomy) or must have a negative serum pregnancy test upon study

- Subject 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

- Measurable disease as per RECIST 1.1 besides the tumor that is expected to be
radiated. See Section 12.2.1 for detailed description. Bony lesions without soft
tissue component are not measurable lesions

- Patient must agree to allow 2 separate biopsies of any malignant lesion. Biopsies do
not need to be done if:

A. Tumor is not considered accessible by either the investigator or the person performing
the biopsy (it is determined the risk is too high due to location near vital organs or too
great of a risk of an adverse event).

B. Patient is on anticoagulation and it would be unsafe to temporarily hold the

C.Consent of the PI not to have a biopsy done.

Exclusion Criteria:

- Any previous treatment with an anti-CTLA4, including tremelimumab or any previous
treatment with a PD1 or PDL1 inhibitor

- Receipt of the last dose of any line of anti-cancer therapy (chemotherapy,
immunotherapy, targeted therapy, biologic therapy, tumor embolization, monoclonal
antibodies, and other investigational agent) 7 days prior to the first dose of study
drug and within 6 weeks for nitrosourea or mitomycin C Prior radiation therapy to
targets other than the site currently being treated is permitted.

- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from a single
electrocardiogram or average from 3 electrocardiograms (ECGs) using Frederica's

- Current or prior use of immunosuppressive medication within 28 days before the first
dose of durvalumab (MEDI4736) or tremelimumab, 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 any corticosteroid for more than 4
consecutive days

- Any unresolved toxicity (CTCAE grade > 1) from previous anti-cancer systemic therapy
unless approved by one of the principal investigators (Drs. Lee or Sherman) Rare
exceptions that would not affect the study (e.g., radiaton induced dysphagia) allowed
with the consent of either principal investigators (Drs. Lee or Sherman)

- Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous
immunotherapy agent, or any unresolved irAE >Grade 1

- Active or prior documented autoimmune disease within the past 2 years Note: Subjects
with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within
the past 2 years) are not excluded. Rare exceptions allowed with the consent of both
principal investigators (Drs. Lee and Sherman)

- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease,
ulcerative colitis).

- Confirmed pneumonitis or interstitial lung disease

- History of primary immunodeficiency

- History of allogeneic organ transplant

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active
bleeding diatheses, Any subject known to have evidence of acute or chronic active
hepatitis B, hepatitis C (PCR positive) or human immunodeficiency virus (HIV), or
Psychiatric illness/social situations that would limit compliance with study
requirements or compromise the ability of the subject to give written informed consent

- Known history of previous clinical diagnosis of active tuberculosis (This does not
include a history of being PPD positive)

- History of leptomeningeal carcinomatosis or active brain metastases receiving
concurrent treatment inclusive of but not limited to surgery, radiation and/or
corticosteroids. Note: Brain metastases that have been treated for anticancer purposes
where there has been no MRI evidence of progression for at least 8 weeks after
treatment are permitted on study

- Receipt of live attenuated vaccination within 30 days prior to study entry or within
30 days of receiving durvalumab (MEDI4736) or tremelimumab

- Any condition that, in the opinion of the investigator, would interfere with
evaluation of study treatment or interpretation of patient safety or study results
Subjects with uncontrolled seizures

- Female patients who are pregnant or breast feeding or male or female patients of
reproductive potential who are not willing to employ effective birth control from
screening to 180 days after the last dose of durvalumab (MEDI4736) + tremelimumab
combination therapy or 90 days after the last dose of durvalumab (MEDI4736)
monotherapy, whichever is the longer time period

- Prior active malignancy within the previous 3 years except for locally curable cancers
such as basal or squamous cell cancer superficial bladder, low risk prostate cancer,
breast, or cervix cancer unless it is believed the malignancy will not affect the
study outcome
We found this trial at
225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-3341
Montvale, NJ
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 212-639-3341
Basking Ridge, NJ
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
Phone: 212-639-3341
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
Commack, NY
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Harrison, New York
Phone: 212-639-3341
Harrison, NY
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480 Red Hill Road
Middletown, New Jersey 07748
Phone: 212-639-3341
Middletown, NJ
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Nancy Lee, MD
Phone: 212-639-3341
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
New York, NY
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1000 North Village Avenue
Rockville Centre, New York 11570
Phone: 212-639-4839
Rockville Centre, NY
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Uniondale, New York 11553
Phone: 212-639-3341
Uniondale, NY
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