Phase
Condition
Endometrial Cancer
Biliary Tract Cancer
Bladder Cancer
Treatment
Pembrolizumab (KEYTRUDA®)
MDNA11 Monotherapy
Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Aged at least 18 years (inclusive at the time of informed consent).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Must be able and willing to provide written informed consent prior to start of anystudy procedures and assessments and must be willing to comply with all studyprocedures.
Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)
Demonstrated adequate organ function
Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECISTv1.1) and documented by CT and/or MRI.
Life expectancy of ≥ 12 weeks.
Women of childbearing potential (WOCBP) must have a negative pregnancy test atscreening and within 72 hours before the first dose of study drug(s). Women must notbe breastfeeding.
Agree to use highly effective contraception methods. WOCBP must agree to use highlyeffective birth control.
Exclusion
Key Exclusion Criteria:
- Last administration of prior antitumor therapy:
Prior systemic anti-cancer therapy including investigational agents within 4weeks (could consider shorter interval for kinase inhibitors or other shorthalf-life drugs) prior to start of treatment.
Prior radiotherapy within 2 weeks prior to start of treatment or has had ahistory of radiation pneumonitis. A 1-week washout is required for palliativeradiation (<2 weeks of radiotherapy) to non-CNS disease.
Radiation therapy to the lung that is > 30Gy within 6 months prior to start oftreatment.
Currently participating in or has participated in a study of an investigationalagent or has used an investigational device within 4 weeks prior to start oftreatment. Concomitant participation in an observational study must bediscussed on a case-by-case basis with the MM for approval.
Has known active CNS metastases and/or carcinomatous meningitis. Patients withpreviously treated brain metastases may participate provided they are radiologicallystable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening),clinically stable and without requirement of steroid treatment for at least 14 daysprior to start of treatment, subject to discussion with MM.
Active malignancy (other than the disease under treatment in the study) within theprevious 3 years except for curable cancers.
Condition requiring long-term systemic treatment with either corticosteroids > 10 mgdaily prednisone equivalent or any other form of immunosuppressive therapy within 7days prior to start of treatment.
Clinically significant active, known or suspected autoimmune disease, or diseasesthat can be exacerbated with immunotherapy.
Severe pulmonary, cardiac or other systemic disease.
Known hepatitis B or C virus infection.
Females who are pregnant or lactating or planning to become pregnant during thestudy.
Has had an allogeneic tissue/solid organ transplant.
Active infection requiring systemic therapy.
Any medical, emotional or psychiatric condition that interfere with the patient'sability to adhere to the protocol
Any other underlying medical conditions that, in the Investigator's opinion, willmake the administration of study drug(s) unsafe or obscure the interpretation oftoxicity determination or adverse events.
Known severe hypersensitivity to any component of study drug(s).
Inability to comply with study and follow up procedures as judged by theInvestigator.
Study Design
Study Description
Connect with a study center
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
AustraliaSite Not Available
Scientia Clinical Research
Randwick, New South Wales 2031
AustraliaActive - Recruiting
Macquarie University
Sydney, New South Wales 2109
AustraliaActive - Recruiting
University of the Sunshine Coast
Buderim, Queensland 4556
AustraliaActive - Recruiting
Gallipoli Medical Research Foundation
Greenslopes, Queensland 4120
AustraliaActive - Recruiting
ICON Cancer Center
South Brisbane, Queensland 4101
AustraliaSite Not Available
Cabrini Research
Malvern, Victoria 3144
AustraliaSite Not Available
Princess Margaret Cancer Center
Toronto, Ontario M4W 3E2
CanadaActive - Recruiting
Mater Misericordiae University Hospital
Dublin, D07 R2WY
IrelandActive - Recruiting
Samsung Medical Center
Seoul, Gangnam-gu
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Korea, Republic ofSite Not Available
The Catholic University of Korea St. Vincent Hospital
Suwon-si, Gyeonggi-do
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, Jongno-gu
Korea, Republic ofSite Not Available
START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria
Lisbon, 1649-035
PortugalActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
SpainActive - Recruiting
START Barcelona / HM Nou Delfos
Barcelona, 08023
SpainActive - Recruiting
Hospital Universitario Hm Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
SpainActive - Recruiting
START Madrid / Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario de Torrejon
Torrejon, 28850
SpainActive - Recruiting
Sharp Memorial Hospital
San Diego, California 92123
United StatesActive - Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United StatesSite Not Available
Providence Saint John's Health Center
Santa Monica, California 90404
United StatesActive - Recruiting
Boca Raton Regional Hospital
Boca Raton, Florida 33486
United StatesActive - Recruiting
Orlando Health Cancer Institute
Orlando, Florida 32806
United StatesSite Not Available
Emory - Winship Cancer Institute
Atlanta, Georgia 30322
United StatesActive - Recruiting
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Gabrail Cancer Center Research
Canton, Ohio 44718
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
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