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Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Sponsor: National Cancer Institute (NCI)
Summary
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 (closed to accrual) 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 (closed to accrual) 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 (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 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 endometrial cancer 46. Clear cell ovarian cancer (closed to accrual) 47. Gestational trophoblastic disease (GTD) 48. Gallbladder cancer 49. Small cell carcinoma of the ovary, hypercalcemic type 50. PD-L1 amplified tumors 51. Angiosarcoma 52. High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor \[PNET\] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 53). Small cell lung cancer is not eligible (closed to accrual) 53. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)
Official title: DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
798
Start Date
2017-01-30
Completion Date
2027-06-01
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Echocardiography Test
Undergo ECHO
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Locations (1007)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Highlands Oncology Group - Rogers
Rogers, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
PCR Oncology
Arroyo Grande, California, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States
Kaiser Permanente-Bellflower
Bellflower, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Keck Medicine of USC Buena Park
Buena Park, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Mills-Peninsula Medical Center
Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Mercy Cancer Center - Carmichael
Carmichael, California, United States
Mercy San Juan Medical Center
Carmichael, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
UC Irvine Health Cancer Center-Newport
Costa Mesa, California, United States
Sutter Davis Hospital
Davis, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Epic Care-Dublin
Dublin, California, United States
Kaiser Permanente Dublin
Dublin, California, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Epic Care Partners in Cancer Care
Emeryville, California, United States
Kaiser Permanente-Fontana
Fontana, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
Kaiser Permanente South Bay
Harbor City, California, United States
Keck Medicine of USC Huntington Beach
Huntington Beach, California, United States
Kaiser Permanente-Irvine
Irvine, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Keck Medicine of USC Koreatown
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Kaiser Permanente West Los Angeles
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
Mercy Cancer Center
Merced, California, United States
Memorial Medical Center
Modesto, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Providence Queen of The Valley
Napa, California, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Kaiser Permanente-Ontario
Ontario, California, United States
Saint Joseph Hospital - Orange
Orange, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Desert Regional Medical Center
Palm Springs, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Kaiser Permanente - Panorama City
Panorama City, California, United States
Keck Medical Center of USC Pasadena
Pasadena, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Kaiser Permanente-Riverside
Riverside, California, United States
Mercy Cancer Center - Rocklin
Rocklin, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Kaiser Permanente Downtown Commons
Sacramento, California, United States
Mercy Cancer Center - Sacramento
Sacramento, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
Kaiser Permanente-San Diego Mission
San Diego, California, United States
Kaiser Permanente-San Diego Zion
San Diego, California, United States
Sharp Memorial Hospital
San Diego, California, United States