A Phase 1 interventional study of SCH 721015 with SCH 209702 in Bladder Neoplasms, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-27.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
The purpose of this first-in-human study is to determine the safety and tolerability of SCH 721015 in subjects with transitional cell carcinoma of the bladder.
A nonrandomized, open-label, rising-dose, parallel-group, multi-center study of SCH 721015 in patients with papillary bladder cancer, or carcinoma in situ that is refractory to Bacillus Calmette-Guerin. Subjects will receive a single intravesical administration of SCH 721015 with SCH 209702 in a total volume of 75 mL with a 1-hour dwell time. Subjects who at 3 months post administration demonstrate a complete response (CR on cystoscopy/biopsy and cytology) and who did not experience dose-limiting toxicity will be allowed to receive a second intravesical administration at the same dose level.
716 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.
This study's enrollment of 17 is below the median of 49 across 549 interventional studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,111 studies on the registry; 130 are open to participants now.
Of its 488 completed or terminated interventional studies of FDA-regulated products, 361 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as:
Genetic: SCH 721015 with SCH 209702
Each subject receives a single intravesical administration of SCH 721015 with SCH 209702 at dose levels of 1 x 10\^9 to 3 x 10\^11 particles/mL (based on assessment of tolerability, intermediate dose levels may be used).
Adverse events, laboratory safety tests, dose-limiting toxicity
Time frame: CBC/chemistry: predose, Days 1-3, 7, 14, 21, & 28, Week 12.
Adverse events, laboratory safety tests, dose-limiting toxicity
Time frame: Additional hematology on Days 4, 5, & 6.
Adverse events, laboratory safety tests, dose-limiting toxicity
Time frame: AEs: Duration of study; up to 3 years postdose for serious events.
Adverse events, laboratory safety tests, dose-limiting toxicity
Time frame: ECG and VS - predose and selected postdose time points.
Timed urine collections for IFNα2b excretion & IP-10.
Time frame: Days 1-7, 10, 14, 21, & 28/29.
Urine samples for SCH 721015 DNA content.
Time frame: Predose, Days 1-7 & 14.
Blood samples for SCH 721015 DNA; SCH 209702, & IFNα2b levels; antiadenoviral & anti-IFNα2b antibodies
Time frame: Pre- & postdose for SCH 721015 DNA; SCH 721015, & IFNα2b levels; & postdose for antibodies.
Urine cytology & FISH
Time frame: Days 1, 30 & 90
Cystoscopy & bladder biopsies
Time frame: Screening & Day 90
No study locations are listed for this record.
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC