NL-OMON53077
Completed
Phase 2
Biomarker discovery study to identify patients with advanced urothelial cancer benefitting from pembrolizumab treatment - RESPONDER
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- urinary tract cancer
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Biomarker discovery study to identify patients with advanced urothelial cancer benefitting from pembrolizumab treatmentEUCTR2017-000976-27-NLErasmus MC Cancer Institute80
Completed
Not Applicable
Investigations on biomarker search in patients with bronchial carcinoma under antibody (checkpoint blockade) therapyC34.9Bronchus or lung, unspecifiedDRKS00022872Krankenhaus Martha-Maria Halle-Dölau30
Completed
Not Applicable
Investigations on biomarker search in patients with non-small-cell bronchial carcinoma under checkpoint inhibitor therapyC34.9Bronchus or lung, unspecifiedDRKS00022767Krankenhaus Martha-Maria Halle-Dölau92
Not yet recruiting
Not Applicable
Biomarker signature discovery study to determine acute bacterial respiratory tract infection.NL-OMON56538evels Diagnostics300
Completed
Not Applicable
Biomarker study; study to identify biomarkers for protein intake, a randomized, fully controlled feeding studyGeen aandoeningenUitscheiding van biomerkers na het eten van eiwit in het gezond menselijk lichaamBiomarkers of protein intakeNL-OMON36525Wageningen Universiteit25