Spots Global Cancer Trial Database for Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer
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Trial Identification
Brief Title: Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer
Official Title: A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) Monotherapy and in Combination With Other Agents in Subjects With Recurrent or Stage IVB Cervical Cancer
Study ID: NCT03786081
Conditions
Study Description
Brief Summary: This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer. The trial consists of two-parts a dose escalation part and an expansion part. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part.
Detailed Description: The dose escalation part will occur in participants with cervical cancer who have progressed during or after standard of care therapy and who are intolerant or ineligible to receive standard of care treatments. Arm A will be conducted by escalating doses of both tisotumab vedotin and bevacizumab. Dose escalations of the tisotumab vedotin + pembrolizumab and tisotumab vedotin + carboplatin combinations (Arms B and C, respectively) will be conducted by combining fixed doses of either pembrolizumab or carboplatin with increasing doses of tisotumab vedotin. The dose expansion part of this study (Arms D through H) will be conducted in 2 populations: participants with cervical cancer who have not received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E, and H) and participants with cervical cancer who have progressed on or after at least 1 but no more than 2 prior systemic therapies (Arms F and G). Participants enrolled to Arms D, E, F and H will receive the RP2D of tisotumab vedotin established in the dose escalation part. Participants enrolled to Arm G will receive tisotumab vedotin weekly (at a dose lower than subjects in all other Arms) for three weeks and 1 week off (28-day treatment cycle).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Arizona Oncology Associates, Phoenix, Arizona, United States
Univ California, Irvine Medical Center, Orange, California, United States
Olive View - UCLA Research and Education Institute, Sylmar, California, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Augusta University, Augusta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Indiana University School of Medicine, Indianapolis, Indiana, United States
University of Kansas Medical Center, Westwood, Kansas, United States
Oschner Clinic, New Orleans, Louisiana, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Montana Cancer Consortium, Billings, Montana, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of North Carolina Chapel Hill, Chapel Hill, North Carolina, United States
University of Cincinnati Physicians Group, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University Wexner Medical Center, Hilliard, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States
Brown University - Women's and Infant Hospital, Providence, Rhode Island, United States
St Francis Hospital Cancer Center, Greenville, South Carolina, United States
Huntsman Cancer Center, Salt Lake City, Utah, United States
Carilion Clinic, Roanoke, Virginia, United States
AZ Sint-Jan, Brugge, , Belgium
Cliniques universitaires Saint-Luc, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
Grand Hôpital de Charleroi, Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen (UZA), Edegem, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
Universitaire Ziekenhuizen Leuven,, Leuven, , Belgium
Centre Hospitalier de l'Ardenne, Libramont, , Belgium
Centre Hospitalier Universitaire (CHU) de Liège, Liège, , Belgium
Grand Hôpital de Charleroi, Loverval, , Belgium
CHU UCL Namur, Namur, , Belgium
Sainte-Elisabeth, Namur, , Belgium
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Ostrava-Poruba, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Fakultni nemocnice Bulovka, Praha, , Czechia
Nemocnice Na Bulovce, Praha, , Czechia
Rigshospitalet, Copenhagen, , Denmark
Cork University Hospital, Cork, , Ireland
Mater Misericordiae University Hospital, Dublin, , Ireland
Waterford Regional Hospital, Waterford, , Ireland
University Hospital Waterford, Waterford, , Ireland
Azienda Ospedaliera Cannizzaro, Catania, , Italy
IEO Istituto Europeo di Oncologia, Milano, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, , Italy
Amsterdam UMC, Locatie AMC, Amsterdam, , Netherlands
AMC Medical Research, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen (UMCG), Groningen, , Netherlands
Radboudumc, Nijmegen, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Erasmus University Medical Center Rotterdam, Rotterdam, , Netherlands
UMC Utrecht, Utrecht, , Netherlands
University Medical Center Utrecht (UMC Utrecht), Utrecht, , Netherlands
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Hospital Universitario Virgen de la Arrixaca, El Palmar, , Spain
Hospital 12 De Octubre, Madrid, , Spain
Baskent University Adana Application and Research Center, Adana, , Turkey
Baskent University Ankara Hospital, Ankara, , Turkey
Velindre Cancer Centre, Cardiff, South Glamorgan, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, Strathclyde, United Kingdom
Royal Marsden Hospital- Sutton, Sutton, Surrey, United Kingdom
Contact Details
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