Spots Global Cancer Trial Database for A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
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Trial Identification
Brief Title: A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
Official Title: A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination With Nivolumab or Nivolumab and Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
Study ID: NCT03026166
Conditions
Study Description
Brief Summary: The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).
Detailed Description: The study planned to enroll three cohorts with approximately 30 participants in each, including a dose-limiting toxicity (DLT) evaluation phase (the first 12 weeks of any treatment) and an expansion phase. Initially, up to 12 participants were to be enrolled into Cohort 1 in order to obtain 6 evaluable participants through the DLT evaluation period of 12 weeks. Safety data were reviewed by a Safety Monitoring Committee (SMC) for each cohort during the DLT evaluation phase before the next cohort opened. Once a new cohort was opened, the previously opened cohort was permitted to continue enrolling participants for the expansion phase for a total of 30 participants per cohort. Only two of the planned three cohorts enrolled participants in the study based on the SMC recommendation after DLTs were identified in Cohort 2.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ucsd /Id# 161030, La Jolla, California, United States
Florida Hospital /ID# 161017, Orlando, Florida, United States
University Cancer & Blood Cent /ID# 161028, Athens, Georgia, United States
University of Chicago /ID# 161006, Chicago, Illinois, United States
The University of Kansas Clini /ID# 162915, Fairway, Kansas, United States
Washington University-School of Medicine /ID# 161011, Saint Louis, Missouri, United States
Rutgers Cancer Institute of NJ /ID# 161032, New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center /ID# 161010, New York, New York, United States
Duke University Medical Center /ID# 161009, Durham, North Carolina, United States
Oregon Health and Science University /ID# 161029, Portland, Oregon, United States
Medical University of South Carolina /ID# 161007, Charleston, South Carolina, United States
Tennessee Oncology, PLLC /ID# 161012, Nashville, Tennessee, United States
Vanderbilt University Med Ctr /ID# 162916, Nashville, Tennessee, United States
Virginia Cancer Institute /ID# 161025, Richmond, Virginia, United States
University of Wisconsin Clinic /ID# 161013, Madison, Wisconsin, United States
CHU de Besancon - Jean Minjoz /ID# 165173, Besancon, Doubs, France
Centre Oscar Lambret /ID# 165169, Lille, Hauts-de-France, France
Institut Gustave Roussy /ID# 165168, Villejuif, Val-de-Marne, France
Institut Sainte Catherine /ID# 165172, Avignon, , France
CHRU de Brest - Hospital Morva /ID# 165170, Brest Cedex, , France
Hopital La Timone /ID# 165171, Marseille, , France
KH Martha-Maria Halle Dolau /ID# 165180, Halle (Saale), Sachsen-Anhalt, Germany
Asklepios Fachkliniken M. Gaut /ID# 165183, Gauting, , Germany
Lungen Clinic Grosshansdorf /ID# 165182, Grosshansdorf, , Germany
Lungenfachklinik Immenhausen /ID# 165181, Immenhausen, , Germany
Istituto Clinico Humanitas /ID# 165176, Rozzano, Milano, Italy
Centro di Riferimento Oncologi /ID# 165174, Aviano, , Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 165178, Catania, , Italy
Istituto Europeo di Oncologia /ID# 165175, Milan, , Italy
AO Univ di Modena /ID# 165177, Modena, , Italy
Clinica Universitar de Navarra - Pamplona /ID# 165165, Pamplona, Navarra, Comunidad, Spain
Hosp Univ Quiron Dexues /ID# 165166, Barcelona, , Spain
Hospital Genl Gregorio Maranon /ID# 165162, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 165164, Madrid, , Spain
Hospital Universitario Madrid /ID# 165163, Madrid, , Spain
Contact Details
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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