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ACTIVE NOT RECRUITING
NCT02834013
PHASE2

Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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

Acinar Cell CarcinomaAdenoid Cystic CarcinomaAdrenal Cortical CarcinomaAdrenal Gland PheochromocytomaAnal Canal Neuroendocrine CarcinomaAnal Canal Undifferentiated CarcinomaAngiosarcomaApocrine NeoplasmAppendix Mucinous AdenocarcinomaBartholin Gland Transitional Cell CarcinomaBasal Cell CarcinomaBladder AdenocarcinomaBreast Metaplastic CarcinomaCervical AdenocarcinomaCholangiocarcinomaChordomaColorectal Squamous Cell CarcinomaDesmoid FibromatosisEndometrial Transitional Cell CarcinomaEndometrioid AdenocarcinomaEsophageal Neuroendocrine CarcinomaEsophageal Undifferentiated CarcinomaExtrahepatic Bile Duct CarcinomaExtramammary Paget DiseaseFallopian Tube AdenocarcinomaFallopian Tube Transitional Cell CarcinomaFibromyxoid TumorGallbladder CarcinomaGastric Neuroendocrine CarcinomaGastric Squamous Cell CarcinomaGastric Undifferentiated CarcinomaGastrointestinal Stromal TumorGestational Trophoblastic TumorGiant Cell CarcinomaHuman Papillomavirus-Independent Cervical Adenocarcinoma, Clear Cell-TypeIntestinal Neuroendocrine CarcinomaIntrahepatic CholangiocarcinomaLung Neuroendocrine TumorLung Sarcomatoid CarcinomaMajor Salivary Gland CarcinomaMalignant Neoplasm of Unknown PrimaryMalignant Odontogenic NeoplasmMalignant Peripheral Nerve Sheath TumorMalignant Solid NeoplasmMalignant Testicular Sex Cord-Stromal TumorMetastatic Pituitary Neuroendocrine TumorMinimally Invasive Lung AdenocarcinomaMixed Mesodermal (Mullerian) TumorMucinous AdenocarcinomaMucinous CystadenocarcinomaNasal Cavity AdenocarcinomaNasal Cavity CarcinomaNasopharyngeal CarcinomaNasopharyngeal Low Grade Papillary AdenocarcinomaNasopharyngeal Undifferentiated CarcinomaOral Cavity CarcinomaOropharyngeal Undifferentiated CarcinomaOvarian AdenocarcinomaOvarian Germ Cell TumorOvarian Mucinous AdenocarcinomaOvarian Squamous Cell CarcinomaOvarian Transitional Cell CarcinomaPancreatic Acinar Cell CarcinomaPancreatic Neuroendocrine CarcinomaParagangliomaParanasal Sinus AdenocarcinomaParanasal Sinus CarcinomaParathyroid Gland CarcinomaPEComaPenile Squamous Cell CarcinomaPeritoneal Mesothelial NeoplasmPlacental ChoriocarcinomaPrimary Peritoneal High Grade Serous AdenocarcinomaPseudomyxoma PeritoneiRare DisorderScrotal Squamous Cell CarcinomaSeminal Vesicle AdenocarcinomaSeminomaSerous CystadenocarcinomaSmall Intestinal AdenocarcinomaSmall Intestinal Squamous Cell CarcinomaSpindle Cell NeoplasmTeratoma With Somatic-Type MalignancyTesticular Non-Seminomatous Germ Cell TumorThyroid Gland CarcinomaTracheal CarcinomaTransitional Cell CarcinomaUreter AdenocarcinomaUreter Squamous Cell CarcinomaUrethral AdenocarcinomaUrethral Squamous Cell CarcinomaVaginal AdenocarcinomaVaginal Squamous Cell Carcinoma, Not Otherwise SpecifiedVulvar Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo ECHO

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

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

And 907 more locations on ClinicalTrials.gov