Pembrolizumab, Chemotherapy, and Radiation Therapy With or Without Surgery in Treating Patients With Anaplastic Thyroid Cancer
Condition: Thyroid Gland Undifferentiated (Anaplastic) Carcinoma
MeSH terms: Thyroid Neoplasms; Thyroid Carcinoma, Anaplastic; Thyroid Diseases
Intervention: Docetaxel; Doxorubicin Hydrochloride; Intensity-Modulated Radiation Therapy; Laboratory Biomarker Analysis; Pembrolizumab; Therapeutic Conventional Surgery
Intervention description: Given IV; Given IV; Undergo IMRT; Correlative studies; Given IV; Undergo surgery
Intervention MeSH terms: Docetaxel; Doxorubicin; Liposomal doxorubicin; Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well pembrolizumab, chemotherapy, and radiation therapy work
      with or without surgery in treating patients with anaplastic thyroid cancer. Monoclonal
      antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and
      spread. Drugs used in chemotherapy, such as docetaxel and doxorubicin hydrochloride, work in
      different ways to stop the growth of tumor cells, either by killing the cells, by stopping
      them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy
      x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, chemotherapy, and
      radiation therapy with or without surgery may kill more tumor cells and work better in
      treating patients with anaplastic thyroid cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of, or cytology reported and confirmed, anaplastic thyroid
             cancer

               -  NOTE: A diagnosis reported as ?poorly differentiated carcinoma consistent with
                  anaplastic thyroid cancer? will be accepted

          -  Absence of prior neck radiotherapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

          -  Hemoglobin >= 9.0 g/dL

          -  White blood cells (WBC)/leukocytes >= 3500/mm^3

          -  Absolute neutrophil count (ANC) >= 1500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with
             well-documented Gilbert?s syndrome)

          -  Aspartate transaminase (AST) =< 3 x ULN

          -  Creatinine =< 1.5 x ULN OR calculated creatinine clearance >= 50 ml/min using the
             Cockcroft-Gault formula

          -  Prothrombin time (PT)/activated partial thromboplastin time (PTT) =< 1.5 x ULN, unless
             subject is receiving anticoagulant therapy and PT or activated (a)PTT is within
             therapeutic range of intended use of anticoagulants

          -  Negative pregnancy test done =< 7 days prior to registration, for persons of
             childbearing potential only

               -  NOTE: If the urine test is positive or cannot be confirmed as negative, a serum
                  pregnancy test will be required

               -  NOTE: Merck requires an additional pregnancy test if eligibility pregnancy test
                  is > 72 hours prior to first dose

          -  Persons of childbearing potential must be willing to use an adequate method of birth
             control for the course of the study through 120 days after the last dose of study
             medication

               -  NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred
                  method of contraception for the patient

          -  Persons able to father a child must agree to use an adequate method of contraception
             starting with the first dose of study therapy through 120 days after the last dose of
             study therapy

               -  NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred
                  method of contraception for the patient

          -  Provide written informed consent

          -  Willing to return to enrolling institution for follow-up (during the active monitoring
             phase of the study)

          -  Willing to provide tissue and blood samples for correlative research purposes

        Exclusion Criteria:

          -  History of non-infectious pneumonitis that required steroids or current pneumonitis

          -  Any of the following:

               -  Pregnant persons

               -  Nursing persons

               -  Persons of childbearing potential who are unwilling to employ adequate
                  contraception

          -  Any autoimmune disease such as inflammatory bowel disease, including but not limited
             to:

               -  Ulcerative colitis

               -  Crohn's disease

               -  Rheumatoid arthritis

               -  Systemic sclerosis

               -  Systemic lupus erythematosus

               -  Autoimmune hepatitis

               -  Other autoimmune disease not listed above

               -  NOTE: Subjects with autoimmune thyroid disease and diabetes mellitus type I will
                  be allowed

          -  Uncontrolled intercurrent illness including, but not limited to,

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia, or

               -  Psychiatric illness/social situations that would limit compliance with study
                  requirements

          -  Other active malignancy =< 6 months prior to registration

               -  EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix or
                  prostate cancer confined to prostate gland with Gleason score < 6 or
                  prostate-specific antigen (PSA) < 1

               -  NOTE: If there is a history of prior malignancy, they must not be receiving other
                  treatment for their cancer; ongoing adjuvant hormonal treatment for breast cancer
                  is allowed

          -  Prior known allergic reaction to pembrolizumab or its excipients

          -  Untreated brain metastasis

          -  Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)
             positive and currently receiving antiretroviral therapy

          -  Receiving any other investigational agent which would be considered as a treatment for
             the primary neoplasm

          -  Received any live vaccine =< 30 days prior to registration

          -  Any of the following conditions =< 6 weeks prior to registration:

               -  Cerebrovascular accident (CVA)

               -  Admission for unstable angina

               -  Cardiac angioplasty or stenting or coronary artery bypass graft surgery

               -  Pulmonary embolism or untreated deep venous thrombosis (DVT)

               -  Arterial thrombosis

               -  Class III or IV heart failure as defined by the New York Heart Association (NYHA)
                  functional classification system