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Spots Global Cancer Trial Database for Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Anteneh A Tesfaye

Affiliation: Yale University Cancer Center LAO

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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