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Brief Title: A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)
Official Title: A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 (001)
Study ID: NCT03861793
Brief Summary: This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.
Detailed Description: This study will evaluate ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mural Oncology Investigational Site, Los Angeles, California, United States
Mural Oncology Investigational Site, Los Angeles, California, United States
Mural Oncology Investigational Site, Washington, District of Columbia, United States
Mural Oncology Investigational Site, Atlanta, Georgia, United States
Mural Oncology Investigational Site, Chicago, Illinois, United States
Mural Oncology Investigational Site, Bethesda, Maryland, United States
Mural Oncology Investigational Site, Detroit, Michigan, United States
Mural Oncology Investigational Site, Saint Paul, Minnesota, United States
Mural Oncology Investigational Site, Morristown, New Jersey, United States
Mural Oncology Investigational Site, Buffalo, New York, United States
Mural Oncology Investigational Site, Huntersville, North Carolina, United States
Mural Oncology Investigational Site, Cincinnati, Ohio, United States
Mural Oncology Investigational Site, Philadelphia, Pennsylvania, United States
Mural Oncology Investigational Site, Charleston, South Carolina, United States
Mural Oncology Investigational Site, Houston, Texas, United States
Mural Oncology Investigational Site, Salt Lake City, Utah, United States
Mural Oncology Investigational Site, Milwaukee, Wisconsin, United States
Mural Oncology Investigational Site, Edmonton, Alberta, Canada
Mural Oncology Investigational Site, Hamilton, Ontario, Canada
Mural Oncology Investigational Sites, Montréal, Quebec, Canada
Mural Oncology Investigational Site, Montréal, Quebec, Canada
Mural Oncology Investigational Site, Montréal, Quebec, Canada
Mural Oncology Investigational Site, Québec, Quebec, Canada
National Cancer Center, Goyang, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Yonsei University Health System - Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital, Suwon, , Korea, Republic of
Mural Oncology Investigational Site, Rotterdam, , Netherlands
Mural Oncology Investigational Site, Utrecht, , Netherlands
Mural Oncology Investigational Site, Badalona, , Spain
Mural Oncology Investigational Site, Córdoba, , Spain
Mural Oncology Investigational Site, Madrid, , Spain
Mural Oncology Investigational Site, Madrid, , Spain
Mural Oncology Investigational Site, Madrid, , Spain
Mural Oncology Investigational Site, Madrid, , Spain
Mural Oncology Investigational Site, Madrid, , Spain
Mural Oncology Investigational Site, Málaga, , Spain
Mural Oncology Investigational Site, Valencia, , Spain
Mural Oncology Investigational Site, Kaohsiung, , Taiwan
Mural Oncology Investigational Site, Taichung, , Taiwan
Mural Oncology Investigational Site, Tainan, , Taiwan
Mural Oncology Investigational Site, Taipei, , Taiwan
Mural Oncology Investigational Site, Taipei, , Taiwan
Mural Oncology Investigational Site, Taipei, , Taiwan
Name: Mural Oncology Medical Director
Affiliation: Mural Oncology
Role: STUDY_DIRECTOR