Biomarker discovery study to identify patients with advanced urothelial cancer benefitting from pembrolizumab treatment - RESPONDER

Erasmus MC Cancer Institute0 sites80 target enrollmentJuly 12, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Erasmus MC Cancer Institute
Enrollment: 80
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 12, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Erasmus MC Cancer Institute

Eligibility Criteria

Inclusion Criteria

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•1\.Should have signed informed consent for CPCT\-02\.
•Note: when a safe biopsy of a metastatic or locally advanced lesion is not deemed possible by the treating investigator, subject may be included in the trial without participation in the CPCT\-02 trial only upon approval by the central principal investigator.
•2\.Be willing and able to provide written informed consent for the trial.
•3\.Be ? 18 years of age on day of signing informed consent.
•4\.Have histologically or cytologically\-confirmed urothelial cancer that is not
•amenable to curative treatment with local and/or systemic therapies.
•5\.Second\-line treatment: have progressive disease after platinum containing chemotherapy as defined by:
•\-Disease progression after treatment with a platinum\-containing regimen for recurrent (disease not amenable to curative treatment)/metastatic disease
•\-Recurrence/progression within 12 months of prior therapy containing platinum

Exclusion Criteria

•1\. Treamtent with an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•2\. Has a diagnosis of immunodeficiency or is receiving high dose systemic steroid therapy (defined as \> 20 mg prednisone or equivalent per day) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•3\. Has a known history of active TB (Bacillus Tuberculosis).
•4\. Hypersensitivity to pembrolizumab or any of its excipients.
•5\. 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.
•6\. 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.
•\- Note: Radiation therapy to a symptomatic solitary lesion or to the brain may be allowed at the investigator’s discretion
•7\. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or