Phase I trial of stereotactic body radiotherapy with concurrent pembrolizumab in metastatic urothelial cancer.

Z Gent0 sites20 target enrollmentMay 12, 2016

ConditionsMetastatic urothelial cancer Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic urothelial cancer
Sponsor: Z Gent
Enrollment: 20
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 12, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Z Gent

Eligibility Criteria

Inclusion Criteria

•1\.Be willing and able to provide written informed consent/assent for the trial.
•2\.Be ? 18 years of age on day of signing informed consent.
•3\.Have measurable disease based on RECIST 1\.1\.
•4\.Have had any prior treatment more than 2 weeks prior to study day 1, treatment naïve patients are allowed
•5\.Histologically confirmed diagnosis of urothelial carcinoma
•6\.Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly\-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1\. Subjects for whom newly\-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
•7\.Have a performance status of 0 or 1 on the ECOG Performance Scale.
•8\.Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
•Table 1 Adequate Organ Function Laboratory Values
•SystemLaboratory Value

Exclusion Criteria

•1\.Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapyor used an investigational device within 4 weeks of the first dose of treatment.
•2\.Has had radiotherapy interfering with SBRT.
•3\.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•4\.Has a known history of active TB (Bacillus Tuberculosis)
•5\.Hypersensitivity to pembrolizumab or any of its excipients.
•6\.Has had a prior anti\-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•7\.Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to a previously administered agent.
•\-Note: Subjects with \= Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
•\-Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•8\.Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.