Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Purpose
This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial enrolls participants for the following cohorts based on condition: 1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07/27/2018) 2. Epithelial tumors of major salivary glands (closed to accrual 03/20/2018) 3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual) 4. Undifferentiated carcinoma of gastrointestinal (GI) tract 5. Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018) 6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10/17/2018) 7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03/20/2018) 8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible 9. Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018) 10. Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018) 11. Sarcomatoid carcinoma of lung 12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma 13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03/30/2018) 14. Trophoblastic tumor: A) Choriocarcinoma (closed to accrual) 15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual) 16. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation (closed to accrual) 17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 18. Squamous cell carcinoma variants of the genitourinary (GU) system 19. Spindle cell carcinoma of kidney, pelvis, ureter 20. Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07/27/2018) 21. Odontogenic malignant tumors 22. Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) (closed to accrual) 23. Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017) 24. Pheochromocytoma, malignant (closed to accrual) 25. Paraganglioma (closed to accrual 11/29/2018) 26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex (closed to accrual) 27. Desmoid tumors 28. Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018) 29. Malignant giant cell tumors 30. Chordoma (closed to accrual 11/29/2018) 31. Adrenal cortical tumors (closed to accrual 06/27/2018) 32. Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2017) 33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03/15/2019) 34. Adenoid cystic carcinoma (closed to accrual 02/06/2018) 35. Vulvar cancer (temporarily closed to accrual) 36. MetaPLASTIC carcinoma (of the breast) (closed to accrual) 37. Gastrointestinal stromal tumor (GIST) (closed to accrual 09/26/2018) 38. Perivascular epithelioid cell tumor (PEComa) 39. Apocrine tumors/extramammary Paget's disease (closed to accrual) 40. Peritoneal mesothelioma (temporarily closed to accrual 05/08/2020) 41. Basal cell carcinoma (temporarily closed to accrual 04/29/2020) 42. Clear cell cervical cancer 43. Esthenioneuroblastoma (closed to accrual) 44. Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual) 45. Clear cell ovarian cancer (closed to accrual) 46. Gestational trophoblastic disease (GTD) 47. Gallbladder cancer 48. Small cell carcinoma of the ovary, hypercalcemic type 49. PD-L1 amplified tumors 50. Angiosarcoma 51. High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 52). Small cell lung cancer is not eligible (temporarily closed to accrual 03/25/2020) 52. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)
Conditions
- Acinar Cell Carcinoma
- Adenoid Cystic Carcinoma
- Adrenal Cortex Carcinoma
- Adrenal Gland Pheochromocytoma
- Anal Canal Neuroendocrine Carcinoma
- Anal Canal Undifferentiated Carcinoma
- Angiosarcoma
- Apocrine Neoplasm
- Appendix Mucinous Adenocarcinoma
- Bartholin Gland Transitional Cell Carcinoma
- Basal Cell Carcinoma
- Bladder Adenocarcinoma
- Breast Metaplastic Carcinoma
- Cervical Adenocarcinoma
- Cervical Clear Cell Adenocarcinoma
- Cholangiocarcinoma
- Chordoma
- Colorectal Squamous Cell Carcinoma
- Desmoid-Type Fibromatosis
- Endometrial Transitional Cell Carcinoma
- Endometrioid Adenocarcinoma
- Esophageal Neuroendocrine Carcinoma
- Esophageal Undifferentiated Carcinoma
- Extrahepatic Bile Duct Carcinoma
- Extramammary Paget Disease
- Fallopian Tube Adenocarcinoma
- Fallopian Tube Transitional Cell Carcinoma
- Fibromyxoid Tumor
- Gallbladder Carcinoma
- Gastric Neuroendocrine Carcinoma
- Gastric Squamous Cell Carcinoma
- Gastric Undifferentiated Carcinoma
- Gastrointestinal Stromal Tumor
- Gestational Trophoblastic Tumor
- Giant Cell Carcinoma
- Intestinal Neuroendocrine Carcinoma
- Intrahepatic Cholangiocarcinoma
- Lung Carcinoid Tumor
- Lung Sarcomatoid Carcinoma
- Major Salivary Gland Carcinoma
- Malignant Odontogenic Neoplasm
- Malignant Peripheral Nerve Sheath Tumor
- Malignant Solid Neoplasm
- Malignant Testicular Sex Cord-Stromal Tumor
- Metastatic Malignant Neoplasm of Unknown Primary
- Minimally Invasive Lung Adenocarcinoma
- Mixed Mesodermal (Mullerian) Tumor
- Mucinous Adenocarcinoma
- Mucinous Cystadenocarcinoma
- Nasal Cavity Adenocarcinoma
- Nasal Cavity Carcinoma
- Nasopharyngeal Carcinoma
- Nasopharyngeal Papillary Adenocarcinoma
- Nasopharyngeal Undifferentiated Carcinoma
- Oral Cavity Carcinoma
- Oropharyngeal Undifferentiated Carcinoma
- Ovarian Adenocarcinoma
- Ovarian Germ Cell Tumor
- Ovarian Mucinous Adenocarcinoma
- Ovarian Squamous Cell Carcinoma
- Ovarian Transitional Cell Carcinoma
- Pancreatic Acinar Cell Carcinoma
- Pancreatic Neuroendocrine Carcinoma
- Paraganglioma
- Paranasal Sinus Adenocarcinoma
- Paranasal Sinus Carcinoma
- Parathyroid Gland Carcinoma
- PEComa
- Peritoneal Mesothelioma
- Pituitary Gland Carcinoma
- Placental Choriocarcinoma
- Primary Peritoneal High Grade Serous Adenocarcinoma
- Pseudomyxoma Peritonei
- Rare Disorder
- Scrotal Squamous Cell Carcinoma
- Seminal Vesicle Adenocarcinoma
- Seminoma
- Serous Cystadenocarcinoma
- Small Intestinal Adenocarcinoma
- Small Intestinal Squamous Cell Carcinoma
- Spindle Cell Neoplasm
- Squamous Cell Carcinoma of the Penis
- Teratoma With Somatic-Type Malignancy
- Testicular Non-Seminomatous Germ Cell Tumor
- Thyroid Gland Carcinoma
- Tracheal Carcinoma
- Transitional Cell Carcinoma
- Ureter Adenocarcinoma
- Ureter Squamous Cell Carcinoma
- Urethral Adenocarcinoma
- Urethral Squamous Cell Carcinoma
- Vaginal Adenocarcinoma
- Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
- Vulvar Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients are eligible under ONE of the following criteria: - For all cohorts except the gestational trophoblastic disease (GTD) (Cohort #47), patients must have histologically and/or biochemically confirmed rare cancer and must be able to submit specimens; to be eligible for the GTD cohort: patients must have disease confirmed by quantitative serum beta-human chorionic gonadotropin (hCG) within 28 days prior to registration and must be able to submit blood specimens (tissue submission is not required for patients who will be registered to the GTD cohort [Cohort #47]); NOTE: Subsequent to site's Institutional Review Board (IRB) approval of revision 3, patients are NOT required to participate in EAY131 "National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)" to register to S1609 OR - FOR PATIENTS WITH PD-L1 AMPLIFICATION (COHORT #50) ONLY: All solid tumors (excluding lymphoma) are allowed for the PD-L1 amplified cohort if they have PD-L1 amplification; patients may be considered for registration to the PD-L1 amplified cohort (Cohort #50) with the confirmation of at least one of the study chairs; PD-L1 amplification is defined as having deoxyribonucleic acid (DNA) copy number of equal to or greater than six by any of the following Clinical Laboratory Improvement Act (CLIA)-approved lab; (Immunohisochemistry [IHC] and fluorescence in situ hybridization [FISH] are not allowed); the assay must be done at or after the diagnosis of advanced disease, but PRIOR TO REGISTRATION; NOTE: patients with PD-L1 overexpression by IHC or PD-L1 amplification by FISH do not quality for this cohort; OR - FOR PATIENTS ENROLLED IN EAY131 "NCI-MATCH" PRIOR TO EAY131 ADDENDUM 10 ONLY: Patients must have histologically confirmed rare cancer that did not have a match to a molecularly-guided therapy on EAY131 "NCI-MATCH" protocol or who are off protocol treatment on EAY131, "NCI-MATCH" and have no further molecularly-matched treatment recommendations per EAY131, "NCI-MATCH" or who are otherwise unable to receive EAY131, "NCI-MATCH" therapy - Patients who do not qualify for one of the histologic cohorts and are not on the ineligible histology list may be considered for registration in the "Not Otherwise Categorized" Rare Tumors cohort with confirmation of at least one of the study chairs via email - NOTE: The "Not Otherwise Categorized" Rare Tumors cohort was permanently closed to accrual on 3/15/2019 - Patients who are determined to have a rare cancer with unknown primary site are eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]), provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis - NOTE: The "Tumor of unknown primary (Cancer of Unknown Primary; CuP" cohort was permanently closed to accrual on 12/22/2017 - Patients must also meet one of the following: - Patients must have progressed following at least one line of standard systemic therapy and there must not be other approved/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolonged survival due to medical issues will be eligible, if other eligibility criteria are met; OR - Patients for whose disease no standard treatment exists that has been shown to prolong overall survival - For all cohorts except the GTD cohort (Cohort #47): Patients must have a diagnostic quality computed tomography (CT) scan or magnetic resonance imaging (MRI), performed within 28 days prior to registration, which demonstrates measurable disease, as defined in RECIST v. 1.1; scans must include imaging of the chest, abdomen and pelvis, with the exception of patients with head/neck cancer, who must have imaging of the chest, abdomen, pelvis and neck; if there is clinical suspicion for bone metastases at the time of enrollment (in the judgement of the treating investigator) bone scan should be performed; bone scans done within 42 days prior to registration may be used to establish baseline condition at registration - No other prior malignancy is allowed except for the following: - Adequately managed stage I or II cancer from which the patient is currently in complete remission - Any other cancer from which the patient has been disease free for one year - Adequately managed stage I or II follicular thyroid or prostate cancer is also eligible, wherein patient is not required to be in complete remission - Note: Second primary tumors are not allowed concurrent with any of the eligible rare cancers - For all cohorts except the PD-L1 amplified tumors cohort (Cohort # 50): Patients may have received either prior anti-CTLA4 or other prior anti-PD-1/anti-PD-L1 therapy, but not both, provided that it is completed >= 4 weeks prior to registration. To be eligible for the PD-L1 amplified tumors cohort (Cohort #50): Patients must not have received anti-PD-1/anti-PD-L1 therapy; prior anti-CTLA-4 is allowed provided that it is completed >= 4 weeks prior to registration - Patients with clinically controlled thyroiditis or pituitary disorders on stable replacement therapy are eligible - Patients with autoimmune disease who are otherwise eligible must not have received steroid and immunosuppressive therapy within 28 days prior to registration - Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 28 days prior to registration and have stable disease at time of registration; these patients must also have a CT or MRI of the brain to evaluate for CNS disease within 42 days prior to registration to S1609; metastatic brain parenchymal disease must have been treated and patient must be off steroids for 7 days prior to registration - Hormonal or endocrine blockade is permitted as long as patient has demonstrated progression on prior therapy (e.g. gonadotrophin releasing hormone [GnRH], somatostatin); long-acting somatostatin analogs (including octreotide) and androgen deprivation treatment (including long-acting leuprolide) are permitted while on protocol therapy - Patients must have a Zubrod performance status of 0-2 - Absolute neutrophil count (ANC) >= 1,000/mcL (within 28 days prior to registration) - Platelets >= 75,000/mcL (within 28 days prior to registration) - Hemoglobin >= 8 g/dL (within 28 days prior to registration) - Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for documented/suspected Gilbert's disease, total bilirubin =< 3.0 x IULN (within 28 days prior to registration) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 3 x IULN (within 28 days prior to registration) - Serum creatinine =< 2.0 x IULN (within 28 days prior to registration) - Creatinine clearance (CrCl) >= 50 mL/min., as estimated by the Cockcroft and Gault formula; estimated creatinine clearance is based on actual body weight (within 28 days prior to registration) - Patients must have adequate thyroid function, as evidenced by either thyroid-stimulating hormone (TSH) or, free thyroxine (T4) serum tests demonstrating values within the normal range, within 28 days prior to registration; at pre-registration, if TSH is not within normal limits, then free T4 must be performed and must be within normal range for patient to be eligible; Note: TSH, with reflex T4 (if TSH is abnormal) is allowable if per institutional standard, provided that free T4 is within normal range; patients who have undergone thyroidectomy or who are on thyroid suppression for their cancer are not required to have normal TSH and free T4 - Patients must have adequate adrenal axis function, as evidenced by cortisol levels within institutional normal ranges (ante meridiem [AM] cortisol preferred), OR adrenocorticotropic hormone (ACTH) values within the institutional normal ranges within 28 days prior to registration; if cortisol levels are not within normal limits prior to registration, then ACTH must be performed and must be within normal ranges for patient to be eligible; Note: Neither cortisol nor ACTH levels are required for patients with primary adrenal tumors (e.g. adrenocortical carcinoma) - For women of childbearing potential, the local investigator must rule out pregnancy; Except for Cohorts 13 and 47, where tumor types may express beta-hCG, women of childbearing potential must have a serum or urine pregnancy test within 7 days prior to registration; for Cohorts 13 and 47, where tumor types may produce hCG (e.g. germ cell tumors or trophoblastic disease), other pregnancy exclusion methods should be used to rule out pregnancy, such as ultrasound examination, documented history of effective contraception, or documented infertility; all females of childbearing potential must have been demonstrated not to be pregnant within 7 days prior to registration and agree to use birth control throughout study and for 23 weeks after completion of protocol therapy; patients must not be pregnant or nursing due to risk of fetal or nursing infant harm; women of childbearing potential must have agreed to use an effective contraceptive method; a woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, she is responsible for beginning contraceptive measures - Men of reproductive potential must have agreed to use birth control throughout the study and for 31 weeks after completion of protocol therapy; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (vasectomy); however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he is responsible for beginning contraceptive measures - Patients who are known to be human immunodeficiency virus (HIV)-positive at registration are eligible at the time of registration: - CD4+ cell count greater or equal to 250 cells/mm^3 - No history of non-malignancy acquired immunodeficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts - Patients must have amylase or lipase within =< 1.5 x IULN without symptoms of pancreatitis at registration, within 28 days prior to registration - Patients must have fully recovered from any adverse effects of major surgery (to =< grade 1) at least 14 days prior to registration
Exclusion Criteria
- Patients who had prior grade 3 or higher immune-related adverse event (e.g. pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer vaccine, cytokine, etc.) are not eligible - Patients are not eligible if they have had or are planned for solid organ transplant - Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy (including radiation, excluding RANKL inhibitors and bisphosphonates); in event patient recently received any other systemic anti-cancer therapy, patient must be off therapy at least 7 days prior to registration and any therapy-induced toxicity must have recovered to =< grade 1, except alopecia and =< grade 2 neuropathy which are allowed; any planned radiation therapy must be completed before registration to S1609 - Patients must not have prior history of allergy or known hypersensitivity to nivolumab or ipilimumab - Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV) infection at time of registration; patients with HBV or HCV that have an undetectable viral load and no residual hepatic impairment are eligible - Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with prednisone dose >= 10 mg); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn's disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia gravis, multiple sclerosis or glomerulonephritis); vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years is permitted; short-term steroid premedication for contrast allergy is permitted - Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3) - Note: Patients with history of CHF or patients who are deemed at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs should have an electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at baseline and at the start of each cycle; patients who have evidence at baseline (or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist, including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram, as clinically indicated - Patients must not have symptomatic interstitial lung disease or pneumonitis
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Arm I (nivolumab, ipilimumab) |
Patients receive nivolumab IV over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Treatment repeats every 42 days for up to 17 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients who complete 17 cycles (2 years) of therapy, may continue receiving the same treatment with nivolumab and ipilimumab, or receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) per physician discretion in the absence of disease progression or unacceptable toxicity. Patients who stop treatment prior to the completion of 17 cycles of therapy may receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) in the absence of disease progression or unacceptable toxicity. |
|
Experimental Arm II (nivolumab) |
Patients receive nivolumab IV over 30 minutes on days 1, 15 and 29. Treatment repeats every 42 days for up to 17 cycles (2 years) in the absence of disease progression or unacceptable toxicity. After 17 cycles (2 years) of therapy, patients may receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) in the absence of disease progression or unacceptable toxicity. |
|
Recruiting Locations
Birmingham, Alabama 35233
Mobile, Alabama 36688
Anchorage, Alaska 98508
Anchorage, Alaska 99504
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Fairbanks, Alaska 99701
Goodyear, Arizona 85338
Site Public Contact
623-207-3000
Kingman, Arizona 86401
Phoenix, Arizona 85004
Site Public Contact
602-406-8222
Fort Smith, Arkansas 72903
Site Public Contact
800-378-9373
Hot Springs, Arkansas 71913
Jonesboro, Arkansas 72401
Little Rock, Arkansas 72205
Site Public Contact
501-686-8274
Anaheim, California 92806
Antioch, California 94531
Arroyo Grande, California 93420
Arroyo Grande, California 93420
Auburn, California 95602
Auburn, California 95603
Baldwin Park, California 91706
Bellflower, California 90706
Berkeley, California 94704
Burbank, California 91505
Cameron Park, California 95682
Castro Valley, California 94546
Costa Mesa, California 92627
Site Public Contact
877-827-8839
Davis, California 95616
Duarte, California 91010
Dublin, California 94568
Site Public Contact
925-875-1677
Dublin, California 94568
Site Public Contact
877-642-4691
Emeryville, California 94608
Site Public Contact
510-835-9900
Emeryville, California 94608
Site Public Contact
510-629-6682
Fontana, California 92335
Fremont, California 94538
Fremont, California 94538
Fresno, California 93720
Harbor City, California 90710
Irvine, California 92618
La Jolla, California 92093
Loma Linda, California 92354
Site Public Contact
909-558-4050
Los Angeles, California 90027
Los Angeles, California 90033
Site Public Contact
323-865-0451
Los Angeles, California 90033
Site Public Contact
323-865-0451
Los Angeles, California 90034
Los Angeles, California 90048
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310-423-8965
Martinez, California 94553-3156
Site Public Contact
925-957-5400
Marysville, California 95901
Site Public Contact
530-749-4400
Modesto, California 95355
Modesto, California 95356
Mountain View, California 94040
Mountain View, California 94040
Newport Beach, California 92663
Site Public Contact
323-865-0451
Oakland, California 94609
Site Public Contact
510-204-1414
Oakland, California 94609
Oakland, California 94611
Ontario, California 91761
Orange, California 92868
Site Public Contact
714-734-6220
Orange, California 92868
Palo Alto, California 94301
Panorama City, California 91402
Pasadena, California 91105
Site Public Contact
323-865-0451
Redwood City, California 94063
Richmond, California 94801
Riverside, California 92505
Roseville, California 95661
Roseville, California 95661
Roseville, California 95661
Sacramento, California 95814
Sacramento, California 95816
Sacramento, California 95817
Site Public Contact
916-734-3089
Sacramento, California 95823
Sacramento, California 95825
San Diego, California 92108
San Diego, California 92120
San Diego, California 92123
San Francisco, California 94115
San Francisco, California 94115
San Jose, California 95119
San Leandro, California 94577
San Luis Obispo, California 93401
San Marcos, California 92078
San Rafael, California 94903
San Rafael, California 94903
Santa Clara, California 95051
Santa Cruz, California 95065
Santa Maria, California 93444
Santa Rosa, California 95403
Santa Rosa, California 95403
South San Francisco, California 94080
Stockton, California 95210
Sunnyvale, California 94086
Truckee, California 96161
Site Public Contact
530-582-6450
Vacaville, California 95687
Vacaville, California 95688
Vallejo, California 94589
Vallejo, California 94589
Walnut Creek, California 94596
Walnut Creek, California 94597
Woodland Hills, California 91367
Aurora, Colorado 80012
Aurora, Colorado 80012
Aurora, Colorado 80045
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720-848-0650
Boulder, Colorado 80301
Boulder, Colorado 80304
Centennial, Colorado 80112
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80909
Site Public Contact
719-365-2406
Colorado Springs, Colorado 80920
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719-364-6700
Denver, Colorado 80205
Denver, Colorado 80209
Denver, Colorado 80210
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80220
Durango, Colorado 81301
Durango, Colorado 81301
Englewood, Colorado 80113
Englewood, Colorado 80113
Greeley, Colorado 80631
Lafayette, Colorado 80026
Lakewood, Colorado 80228
Littleton, Colorado 80120
Littleton, Colorado 80122
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
Longmont, Colorado 80501
Longmont, Colorado 80501
Loveland, Colorado 80539
Parker, Colorado 80138
Pueblo, Colorado 81004
Derby, Connecticut 06418
Fairfield, Connecticut 06824
Guilford, Connecticut 06437
Hartford, Connecticut 06105
New Haven, Connecticut 06510
New Haven, Connecticut 06520
North Haven, Connecticut 06473
Trumbull, Connecticut 06611
Waterbury, Connecticut 06708
West Haven, Connecticut 06516
Site Public Contact
203-937-3421
Frankford, Delaware 19945
Lewes, Delaware 19958
Newark, Delaware 19713
Newark, Delaware 19713
Newark, Delaware 19713
Newark, Delaware 19718
Rehoboth Beach, Delaware 19971
Seaford, Delaware 19973
Wilmington, Delaware 19801
Washington, District of Columbia 20007
Site Public Contact
202-444-2223
Washington, District of Columbia 20016
Aventura, Florida 33180
Fort Lauderdale, Florida 33308
Site Public Contact
954-267-7750
Gainesville, Florida 32610
Hollywood, Florida 33021
Miami Beach, Florida 33140
Orlando, Florida 32806
Pembroke Pines, Florida 33028
Site Public Contact
954-265-4325
Tampa, Florida 33607
Tampa, Florida 33612
Tampa, Florida 33612
Atlanta, Georgia 30308
Site Public Contact
888-946-7447
Atlanta, Georgia 30322
Site Public Contact
404-778-1868
Atlanta, Georgia 30342
Site Public Contact
404-851-7115
Columbus, Georgia 31904
Decatur, Georgia 30033
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404-321-6111
Fayetteville, Georgia 30214
Rome, Georgia 30165
Savannah, Georgia 31405
Valdosta, Georgia 31602
'Aiea, Hawaii 96701
Site Public Contact
808-539-2273
'Aiea, Hawaii 96701
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808-486-6000
'Aiea, Hawaii 96701
Site Public Contact
808-487-7447
'Aiea, Hawaii 96701
Site Public Contact
808-678-9000
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
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808-532-0315
Honolulu, Hawaii 96813
Site Public Contact
808-545-8548
Honolulu, Hawaii 96813
Site Public Contact
808-522-4333
Honolulu, Hawaii 96813
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808-586-2979
Honolulu, Hawaii 96817
Site Public Contact
808-536-4888
Honolulu, Hawaii 96817
Site Public Contact
808-547-9816
Honolulu, Hawaii 96817
Site Public Contact
808-531-8521
Honolulu, Hawaii 96817
Site Public Contact
808-547-6881
Honolulu, Hawaii 96819
Honolulu, Hawaii 96826
Site Public Contact
808-983-6090
Lihue, Hawaii 96766
Site Public Contact
808-535-7960
Boise, Idaho 83706
Boise, Idaho 83712
Caldwell, Idaho 83605
Coeur d'Alene, Idaho 83814
Emmett, Idaho 83617
Fruitland, Idaho 83619
Meridian, Idaho 83642
Meridian, Idaho 83642
Nampa, Idaho 83686
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Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Twin Falls, Idaho 83301
Aurora, Illinois 60504
Bloomington, Illinois 61704
Burr Ridge, Illinois 60527
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708-216-9000
Canton, Illinois 61520
Carbondale, Illinois 62902
Carterville, Illinois 62918
Carthage, Illinois 62321
Centralia, Illinois 62801
Chicago, Illinois 60608
Chicago, Illinois 60611
Chicago, Illinois 60612
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312-864-5204
Chicago, Illinois 60612
Chicago, Illinois 60637
Chicago, Illinois 60657
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773-296-5360
Danville, Illinois 61832
Decatur, Illinois 62526
Decatur, Illinois 62526
DeKalb, Illinois 60115
Dixon, Illinois 61021
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815-285-7800
Effingham, Illinois 62401
Effingham, Illinois 62401
Eureka, Illinois 61530
Galesburg, Illinois 61401
Galesburg, Illinois 61401
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309-344-2831
Geneva, Illinois 60134
Harvey, Illinois 60426
Kewanee, Illinois 61443
Lake Forest, Illinois 60045
Macomb, Illinois 61455
Mattoon, Illinois 61938
Maywood, Illinois 60153
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Melrose Park, Illinois 60160
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Mount Vernon, Illinois 62864
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618-242-4600
New Lenox, Illinois 60451
O'Fallon, Illinois 62269
Orland Park, Illinois 60462
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Orland Park, Illinois 60462
Ottawa, Illinois 61350
Pekin, Illinois 61554
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Peoria, Illinois 61615
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Peoria, Illinois 61636
Peoria, Illinois 61637
Peru, Illinois 61354
Peru, Illinois 61354
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Princeton, Illinois 61356
Springfield, Illinois 62702
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Springfield, Illinois 62702
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Springfield, Illinois 62781
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Urbana, Illinois 61801
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Warrenville, Illinois 60555
Yorkville, Illinois 60560
Zion, Illinois 60099
Avon, Indiana 46123
Carmel, Indiana 46032
Evansville, Indiana 47713
Fort Wayne, Indiana 46845
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877-784-4673
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Newburgh, Indiana 47630
Richmond, Indiana 47374
South Bend, Indiana 46601
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Ames, Iowa 50010
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515-956-4132
Ames, Iowa 50010
Boone, Iowa 50036
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Cedar Rapids, Iowa 52403
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Cedar Rapids, Iowa 52403
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Clive, Iowa 50325
Clive, Iowa 50325
Council Bluffs, Iowa 51503
Creston, Iowa 50801
Des Moines, Iowa 50309
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Jefferson, Iowa 50129
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Marshalltown, Iowa 50158
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West Des Moines, Iowa 50266-7700
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West Des Moines, Iowa 50266
Chanute, Kansas 66720
Dodge City, Kansas 67801
El Dorado, Kansas 67042
Fairway, Kansas 66205
Hays, Kansas 67601
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Independence, Kansas 67301
Kansas City, Kansas 66112
Kansas City, Kansas 66160
Kingman, Kansas 67068
Lawrence, Kansas 66044
Liberal, Kansas 67905
Manhattan, Kansas 66502
McPherson, Kansas 67460
Newton, Kansas 67114
Olathe, Kansas 66061
Overland Park, Kansas 66210
Overland Park, Kansas 66211
Parsons, Kansas 67357
Pittsburg, Kansas 66762
Pratt, Kansas 67124
Salina, Kansas 67401
Salina, Kansas 67401
Topeka, Kansas 66606
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785-295-8000
Wellington, Kansas 67152
Westwood, Kansas 66205
Wichita, Kansas 67208
Wichita, Kansas 67214
Wichita, Kansas 67214
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Winfield, Kansas 67156
Bardstown, Kentucky 40004
Corbin, Kentucky 40701
Lexington, Kentucky 40504
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Shepherdsville, Kentucky 40165
Baton Rouge, Louisiana 70809
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Kenner, Louisiana 70065
Metairie, Louisiana 70006
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New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
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Bangor, Maine 04401
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Baltimore, Maryland 21204
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Baltimore, Maryland 21287
Bethesda, Maryland 20892
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Cumberland, Maryland 21502
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Frederick, Maryland 21701
Frederick, Maryland 21702
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Burlington, Massachusetts 01805
Peabody, Massachusetts 01960
Springfield, Massachusetts 01199
Adrian, Michigan 49221
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Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48109
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Battle Creek, Michigan 49017
Brighton, Michigan 48114
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Brighton, Michigan 48116
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Brownstown, Michigan 48183
Canton, Michigan 48188
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Caro, Michigan 48723
Chelsea, Michigan 48118
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Clarkston, Michigan 48346
Clarkston, Michigan 48346
Clinton Township, Michigan 48038
Dearborn, Michigan 48126
Detroit, Michigan 48202
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East China Township, Michigan 48054
Escanaba, Michigan 49829
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
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Grand Rapids, Michigan 49503
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Grosse Pointe Woods, Michigan 48236
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Jackson, Michigan 49201
Kalamazoo, Michigan 49007
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Lansing, Michigan 48912
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Macomb, Michigan 48044
Macomb, Michigan 48044
Manistique, Michigan 49854
Marlette, Michigan 48453
Monroe, Michigan 48162
Monroe, Michigan 48162
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800-444-3561
Muskegon, Michigan 49444
Niles, Michigan 49120
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616-391-1230
Norton Shores, Michigan 49444
Novi, Michigan 48374
Novi, Michigan 48377
Pontiac, Michigan 48341
Pontiac, Michigan 48341
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Reed City, Michigan 49677
Saginaw, Michigan 48601
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Saint Joseph, Michigan 49085
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Shelby, Michigan 48315
Southfield, Michigan 48075
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Traverse City, Michigan 49684
Warren, Michigan 48088
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West Bloomfield, Michigan 48322
West Branch, Michigan 48661
Wyoming, Michigan 49519
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48197
Aitkin, Minnesota 56431
Bemidji, Minnesota 56601
Brainerd, Minnesota 56401
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
Cambridge, Minnesota 55008
Coon Rapids, Minnesota 55433
Deer River, Minnesota 56636
Detroit Lakes, Minnesota 56501
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Edina, Minnesota 55435
Fergus Falls, Minnesota 56537
Fosston, Minnesota 56542
Fridley, Minnesota 55432
Hibbing, Minnesota 55746
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218-786-3308
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55454
Monticello, Minnesota 55362
New Ulm, Minnesota 56073
Park Rapids, Minnesota 56470
Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Sandstone, Minnesota 55072
Shakopee, Minnesota 55379
Stillwater, Minnesota 55082
Thief River Falls, Minnesota 56701
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605-312-3320
Virginia, Minnesota 55792
Waconia, Minnesota 55387
Willmar, Minnesota 56201
Woodbury, Minnesota 55125
Worthington, Minnesota 56187
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Wyoming, Minnesota 55092
Columbus, Mississippi 39705
Grenada, Mississippi 38901
Gulfport, Mississippi 39502
Hattiesburg, Mississippi 39401
Hattiesburg, Mississippi 39404
Jackson, Mississippi 39216
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601-815-6700
New Albany, Mississippi 38652
Oxford, Mississippi 38655
Southhaven, Mississippi 38671
Ballwin, Missouri 63011
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314-251-7058
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
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573-651-5550
Chesterfield, Missouri 63017
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314-205-6936
Creve Coeur, Missouri 63141
Farmington, Missouri 63640
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314-996-5569
Jefferson City, Missouri 65109
Joplin, Missouri 64804
Joplin, Missouri 64804
Kansas City, Missouri 64108
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816-404-4375
Kansas City, Missouri 64154
Lee's Summit, Missouri 64064
Rolla, Missouri 65401
Rolla, Missouri 65401
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573-458-6379
Saint Joseph, Missouri 64506
Saint Louis, Missouri 63109
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314-353-1870
Saint Louis, Missouri 63110
Saint Louis, Missouri 63129
Saint Louis, Missouri 63131
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314-996-5569
Saint Louis, Missouri 63136
Saint Louis, Missouri 63141
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314-251-7066
Saint Peters, Missouri 63376
Sainte Genevieve, Missouri 63670
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314-996-5569
Springfield, Missouri 65804
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417-269-4520
Springfield, Missouri 65807
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417-269-4520
Sullivan, Missouri 63080
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314-996-5569
Sunset Hills, Missouri 63127
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314-996-5569
Washington, Missouri 63090
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636-390-1600
Anaconda, Montana 59711
Billings, Montana 59101
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
Kalispell, Montana 59901
Missoula, Montana 59804
Grand Island, Nebraska 68803
Kearney, Nebraska 68847
Lincoln, Nebraska 68510
Omaha, Nebraska 68114
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402-354-5144
Omaha, Nebraska 68122
Omaha, Nebraska 68124
Omaha, Nebraska 68130
Omaha, Nebraska 68131
Papillion, Nebraska 68046
Carson City, Nevada 89703
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89052
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Henderson, Nevada 89074
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Las Vegas, Nevada 89128
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Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
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Las Vegas, Nevada 89135
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Las Vegas, Nevada 89144
Las Vegas, Nevada 89148-2405
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Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Pahrump, Nevada 89048
Reno, Nevada 89502
Reno, Nevada 89503
Reno, Nevada 89509
Lebanon, New Hampshire 03756
Manchester, New Hampshire 03102
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603-629-1828
Nashua, New Hampshire 03063
Morristown, New Jersey 07960
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973-971-5900
Pompton, New Jersey 07444
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973-971-5990
Summit, New Jersey 07902
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908-522-2043
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87109
Albuquerque, New Mexico 87110
Las Cruces, New Mexico 88011
Rio Rancho, New Mexico 87124
Bronx, New York 10461
Bronx, New York 10461
Bronx, New York 10467
Buffalo, New York 14263
Glens Falls, New York 12801
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518-926-6700
New York, New York 10016
Rochester, New York 14642
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585-275-5830
Asheville, North Carolina 28803
Clinton, North Carolina 28328
Clyde, North Carolina 28721
Goldsboro, North Carolina 27534
Hendersonville, North Carolina 28791
Hendersonville, North Carolina 28792
Jacksonville, North Carolina 28546
Kenansville, North Carolina 28349
Kinston, North Carolina 28501
Richlands, North Carolina 28574
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
Fargo, North Dakota 58103
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701-234-6161
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Jamestown, North Dakota 58401
Beavercreek, Ohio 45431
Belpre, Ohio 45714
Boardman, Ohio 44512
Canton, Ohio 44708
Canton, Ohio 44708
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888-293-4673
Centerville, Ohio 45459
Centerville, Ohio 45459
Chillicothe, Ohio 45601
Cincinnati, Ohio 45220
Cincinnati, Ohio 45236
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Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
Cleveland, Ohio 44109
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Columbus, Ohio 43210
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Dayton, Ohio 45409
Dayton, Ohio 45415
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Delaware, Ohio 43015
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Dublin, Ohio 43016
Findlay, Ohio 45840
Findlay, Ohio 45840
Findlay, Ohio 45840
Franklin, Ohio 45005-1066
Franklin, Ohio 45005
Greenville, Ohio 45331
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Grove City, Ohio 43123
Kettering, Ohio 45409
Kettering, Ohio 45429
Lancaster, Ohio 43130
Mansfield, Ohio 44903
Marietta, Ohio 45750
Marion, Ohio 43302
Mount Vernon, Ohio 43050
Newark, Ohio 43055
Newark, Ohio 43055
Portsmouth, Ohio 45662
Sandusky, Ohio 44870
Sylvania, Ohio 43560
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419-824-1842
Toledo, Ohio 43606
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419-824-1842
Toledo, Ohio 43623
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800-444-3561
Troy, Ohio 45373
Troy, Ohio 45373
Warrensville Heights, Ohio 44122
Warren, Ohio 44484
Westerville, Ohio 43081
Youngstown, Ohio 44501
Zanesville, Ohio 43701
Lawton, Oklahoma 73505
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877-231-4440
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73120
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405-752-3402
Tulsa, Oklahoma 74133
Baker City, Oregon 97814
Bend, Oregon 97701
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Gresham, Oregon 97030
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503-413-2150
Newberg, Oregon 97132
Ontario, Oregon 97914
Portland, Oregon 97210
Portland, Oregon 97213
Portland, Oregon 97225
Portland, Oregon 97227
Portland, Oregon 97239
Redmond, Oregon 97756
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541-706-2909
Tualatin, Oregon 97062
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503-413-1742
Allentown, Pennsylvania 18103
Bethlehem, Pennsylvania 18017
Chadds Ford, Pennsylvania 19317
Doylestown, Pennsylvania 18901
East Stroudsburg, Pennsylvania 18301
Erie, Pennsylvania 16544
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814-452-5000
Hazleton, Pennsylvania 18201
Jefferson Hills, Pennsylvania 15025
Monroeville, Pennsylvania 15146
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412-858-7746
Philadelphia, Pennsylvania 19107
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215-955-6084
Philadelphia, Pennsylvania 19124
Pittsburgh, Pennsylvania 15212
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877-284-2000
Pittsburgh, Pennsylvania 15224
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412-578-5000
Pittsburgh, Pennsylvania 15232
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412-647-8073
Pottstown, Pennsylvania 19464
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610-327-7544
Wexford, Pennsylvania 15090
Boiling Springs, South Carolina 29316
Charleston, South Carolina 29425
Clinton, South Carolina 29325
Easley, South Carolina 29640
Gaffney, South Carolina 29341
Georgetown, South Carolina 29440
Greenville, South Carolina 29601
Greenville, South Carolina 29605
Greenville, South Carolina 29605
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Greenville, South Carolina 29607
Greenville, South Carolina 29615
Greer, South Carolina 29650
Greer, South Carolina 29651
Seneca, South Carolina 29672
Spartanburg, South Carolina 29303
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864-560-6812
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29307
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864-560-6812
Union, South Carolina 29379
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57117-5134
Collierville, Tennessee 38017
Franklin, Tennessee 37067
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800-811-8480
Memphis, Tennessee 38120
Nashville, Tennessee 37204
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800-811-8480
Nashville, Tennessee 37232
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800-811-8480
Bryan, Texas 77802
Fort Worth, Texas 76104
Houston, Texas 77026-1967
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713-566-5000
Houston, Texas 77030
San Antonio, Texas 78229
American Fork, Utah 84003
Cedar City, Utah 84720
Farmington, Utah 84025
Logan, Utah 84321
Murray, Utah 84107
Ogden, Utah 84403
Provo, Utah 84604
Riverton, Utah 84065
Saint George, Utah 84770
Salt Lake City, Utah 84106
Salt Lake City, Utah 84112
Salt Lake City, Utah 84143
South Jordan, Utah 84009
Berlin, Vermont 05602
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802-225-5400
Burlington, Vermont 05401
Burlington, Vermont 05405
Richmond, Virginia 23298
Aberdeen, Washington 98520
Auburn, Washington 98001
Bellevue, Washington 98004
Bellingham, Washington 98225
Bremerton, Washington 98310
Bremerton, Washington 98310
Burien, Washington 98166
Centralia, Washington 98531
Edmonds, Washington 98026
Enumclaw, Washington 98022
Everett, Washington 98201
Federal Way, Washington 98003
Gig Harbor, Washington 98335
Issaquah, Washington 98029
Kennewick, Washington 99336
Lacey, Washington 98503
Lakewood, Washington 98499
Longview, Washington 98632
Mount Vernon, Washington 98274
Mount Vernon, Washington 98274
Port Townsend, Washington 98368
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360-344-3091
Poulsbo, Washington 98370
Puyallup, Washington 98372
Renton, Washington 98055
Seattle, Washington 98104
Seattle, Washington 98107
Seattle, Washington 98109
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800-804-8824
Seattle, Washington 98109
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800-804-8824
Seattle, Washington 98122-4307
Seattle, Washington 98195
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800-804-8824
Sedro-Woolley, Washington 98284
Shelton, Washington 98584
Tacoma, Washington 98405
Tacoma, Washington 98405
Tacoma, Washington 98405
Vancouver, Washington 98664
Vancouver, Washington 98684
Vancouver, Washington 98686
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503-413-2150
Walla Walla, Washington 99362
Wenatchee, Washington 98801
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509-665-5800
Yelm, Washington 98597
Huntington, West Virginia 25701
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304-399-6617
Appleton, Wisconsin 54915
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Brookfield, Wisconsin 53045
Chilton, Wisconsin 53014
Chippewa Falls, Wisconsin 54729
Eau Claire, Wisconsin 54701
Franklin, Wisconsin 53132
Franklin, Wisconsin 53132
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
La Crosse, Wisconsin 54601
Ladysmith, Wisconsin 54848
Marshfield, Wisconsin 54449
Mequon, Wisconsin 53097
Milwaukee, Wisconsin 53210
Milwaukee, Wisconsin 53211
Milwaukee, Wisconsin 53215
Minocqua, Wisconsin 54548
New Richmond, Wisconsin 54017
Oconto Falls, Wisconsin 54154
Oshkosh, Wisconsin 54904
Racine, Wisconsin 53405
Rhinelander, Wisconsin 54501
Rice Lake, Wisconsin 54868
Sheboygan, Wisconsin 53081
Stevens Point, Wisconsin 54481
Stevens Point, Wisconsin 54482
Sturgeon Bay, Wisconsin 54235-1495
Wausau, Wisconsin 54401
Wauwatosa, Wisconsin 53226
Weston, Wisconsin 54476
Wisconsin Rapids, Wisconsin 54494
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
Sheridan, Wyoming 82801
More Details
- NCT ID
- NCT02834013
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. II. To evaluate the overall response rate (ORR) in patients with gestational trophoblastic tumors treated with ipilimumab plus nivolumab combination immunotherapy. III. To evaluate the RECIST v1.1 overall response rate (ORR) in patients PD-L1 amplified cancers treated with nivolumab immunotherapy. SECONDARY OBJECTIVES: I. To evaluate toxicities in each cohort. II. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune related (i)RECIST ORR (iORR), and iRECIST PFS (iPFS) across cohorts and within each cohort. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I (ALL COHORTS EXCEPT THE PD-L1 AMPLIFIED COHORT): Patients receive nivolumab intravenously (IV) over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Treatment repeats every 42 days for up to 17 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients who complete 17 cycles (2 years) of therapy, may continue receiving the same treatment with nivolumab and ipilimumab, or receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) per physician discretion in the absence of disease progression or unacceptable toxicity. Patients who stop treatment prior to the completion of 17 cycles of therapy may receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) in the absence of disease progression or unacceptable toxicity. ARM II (PD-L1 AMPLIFIED COHORT): Patients receive nivolumab IV over 30 minutes on days 1, 15 and 29. Treatment repeats every 42 days for up to 17 cycles (2 years) in the absence of disease progression or unacceptable toxicity. After 17 cycles (2 years) of therapy, patients may receive nivolumab once every 14 or 28 days (2 weeks or 4 weeks) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 10 years from registration.