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Brief Title: Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors
Official Title: A Phase 2 Study of XL184 (Cabozantinib) in Combination With Nivolumab and Ipilimumab for the Treatment of Poorly Differentiated Neuroendocrine Carcinomas
Study ID: NCT04079712
Brief Summary: This phase II trial studies how well the combination of XL184 (cabozantinib), nivolumab, and ipilimumab work in treating patients with poorly differentiated neuroendocrine tumors (i.e., neuroendocrine tumor that does not look like the normal tissue it arose from). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving cabozantinib, nivolumab and ipilimumab may shrink the cancer.
Detailed Description: PRIMARY OBJECTIVE: I. To evaluate the overall response rate (ORR) associated with the combination of XL184 (cabozantinib), nivolumab, and ipilimumab in patients with advanced poorly-differentiated neuroendocrine carcinomas (NECs), after the failure of at least one line of prior therapy. SECONDARY OBJECTIVES: I. To evaluate progression-free survival (PFS). II. To measure the safety and tolerability of the combination of XL184 (cabozantinib), nivolumab, and ipilimumab in patients with advanced, poorly-differentiated NECs. III. To evaluate disease control rate (DCR). IV. To measure duration of response (DOR). V. To describe the tumor molecular profile using whole exome sequencing (WES) and correlate it with treatment outcome. VI. To describe the tumor molecular profile using ribonucleic acid (RNA) sequencing (RNAseq) and correlate it with treatment outcome. EXPLORATORY OBJECTIVES: I. To measure the tumor-infiltrating CD8+ T lymphocytes in pre- and on-treatment biopsies. II. To measure tumor-infiltrating myeloid derived suppressor cells (MDSCs) in pre- and on-treatment biopsies. III. To measure tumor-infiltrating tumor-associated macrophages (TAM) in the pre and on-treatment biopsies. IV. To measure the expression of programmed death-ligand 1 (PD-L1) in tumor cells and infiltrating immune cells. OUTLINE: Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-21 of cycles 1-4 and days 1-28 of subsequent cycles, nivolumab intravenously (IV) over 30 minutes on day 1, and ipilimumab IV over 90 minutes on day 1 of cycles 1-4 only. Treatment repeats every 21 for 4 cycles then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks, and then every 3 months thereafter.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Banner University Medical Center - Tucson, Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northwestern University, Chicago, Illinois, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
HaysMed, Hays, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Olathe Health Cancer Center, Olathe, Kansas, United States
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
Ascension Via Christi - Pittsburg, Pittsburg, Kansas, United States
Salina Regional Health Center, Salina, Kansas, United States
University of Kansas Health System Saint Francis Campus, Topeka, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
University Health Truman Medical Center, Kansas City, Missouri, United States
University of Kansas Cancer Center - North, Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States
University of Kansas Cancer Center at North Kansas City Hospital, North Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Wake Forest University at Clemmons, Clemmons, North Carolina, United States
Wake Forest Baptist Health - Wilkes Medical Center, Wilkesboro, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Farmington Health Center, Farmington, Utah, United States
University of Utah Sugarhouse Health Center, Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Name: Anteneh A Tesfaye
Affiliation: Yale University Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR