Spots Global Cancer Trial Database for Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors
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Trial Identification
Brief Title: Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors
Official Title: A Phase 1 Study of Pembrolizumab (MK-3475) in Combination With Recombinant Interleukin-12 in Patients With Solid Tumors
Study ID: NCT03030378
Study Description
Brief Summary: This phase I trial studies the side effects and best dose of pembrolizumab and recombinant interleukin-12 in treating patients with solid tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Recombinant interleukin-12 may kill tumor cells by blocking blood flow to the tumor and by stimulating white blood cells to kill tumor cells. Giving pembrolizumab and recombinant interleukin-12 may work better than giving pembrolizumab alone in treating patients with solid tumors.
Detailed Description: PRIMARY OBJECTIVE: I. Establish the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of edodekin alfa (recombinant human interleukin \[rhIL\]-12) in combination with pembrolizumab (MK-3475). SECONDARY OBJECTIVES: I. Evaluate the safety of the regimen by continuously monitoring adverse events that will be documented utilizing Common Terminology Criteria for Adverse Events (CTCAE) version (v).5.0. II. Evaluate the overall response rate (Response Evaluation Criteria in Solid Tumors \[RECIST\] v.1.1) and the progression free survival of patients enrolled on the study. III. Measure CD8+ T cell infiltration by immunohistochemistry in tumor biopsies obtained pre-treatment, after one week of rhIL-12 and after 2 cycles of pembrolizumab (MK-3475) in combination with rhIL-12. EXPLORATORY OBJECTIVE: I. Conduct exploratory translational laboratory correlative studies utilizing banked biospecimens (tumor, blood, and stool) obtained pre-treatment and during therapy. OUTLINE: This is a dose-escalation study of recombinant interleukin-12. Patients receive recombinant interleukin-12 subcutaneously (SC) on days 2, 5, 9, and 12 and pembrolizumab intravenously (IV) over 30 minutes on day 8 of cycle 1 and day 1 of subsequent cycles. Treatment continues for 28 days for cycle 1 and repeats every 21 days for subsequent cycles for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patient then receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 additional cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a computed tomography (CT), positron emission tomography (PET), and/or magnetic resonance imaging (MRI), as well as collection of blood during screening, on study, and during follow-up. Patients also undergo a tumor biopsy during screening and on study. After completion of study treatment, patients are followed up every 12 weeks for 2 year and then every 24 weeks for up to 5 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
Yale University, New Haven, Connecticut, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, 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
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Contact Details
Name: Diwakar Davar
Affiliation: University of Pittsburgh Cancer Institute LAO
Role: PRINCIPAL_INVESTIGATOR
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