Spots Global Cancer Trial Database for A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)
Official Title: A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination With M9241(NHS-IL12) in Subjects With Locally Advanced, Unresectable, or Metastatic Solid Tumors
Study ID: NCT02994953
Conditions
Study Description
Brief Summary: The study consists of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase will evaluate the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally advanced, unresectable, or metastatic solid tumors. Expansion phase will assess the safety and clinical activity of the combination regimen in selected tumor types. In Expansion phase subjects who have completed the combination treatment of avelumab at a given dose level of M9241, a safety review will be performed by the Safety monitoring committee in order to make a decision on the next dose level. Successive cohorts of 3 to 6 subjects will be treated with escalating doses of M9241 with avelumab intravenous (IV).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
California Cancer Associates for Research & Excellence, Inc., San Diego, California, United States
Sharp Memorial Hospital, San Diego, California, United States
St Joseph Heritage Healthcare, Santa Rosa, California, United States
Yale University Institutional Review Board, New Haven, Connecticut, United States
Holy Cross Hospital Inc., Fort Lauderdale, Florida, United States
Hematology - Oncology Associates of the Treasure Coast, Port Saint Lucie, Florida, United States
Metairie Oncologists, LLC, Metairie, Louisiana, United States
National Cancer Institute, Bethesda, Maryland, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Washington University, Saint Louis, Missouri, United States
UC Health, LLC., Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Cedar Sinai Medical Center, Ashland, Oregon, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Mary Crowley Cancer Research Centers, Dallas, Texas, United States
University of Vermont Medical Center, Burlington, Vermont, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
Centre Hospitalier de l'Ardenne - Pharmacie, Libramont, , Belgium
GZA Ziekenhuizen - Campus Sint-Augustinus, Wilrijk, , Belgium
CHU Bordeaux - Hôpital Saint André, Bordeaux cedex, , France
Centre Georges François Leclerc, Dijon cedex, , France
Centre Oscar Lambret, Lille cedex, , France
Hôpital de la Timone# - CPCEM CIC - Bat F 1er étage, Marseille cedex 5, , France
Centre Hospitalier Lyon Sud, Pierre Benite cedex, , France
Centre Paul Strauss, Strasbourg Cedex, , France
Orszagos Onkologiai Intezet, Budapest, , Hungary
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
IOV - Istituto Oncologico Veneto IRCCS, Padova, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena, , Italy
Amsterdam UMC, Locatie VUMC, Amsterdam, , Netherlands
Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Maastricht University Medical Center, Maastricht, , Netherlands
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Contact Details
Name: Medical Responsible
Affiliation: EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
