Phase 2
N=36
First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma
Urothelial Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01524991 ↗Enrolled (actual)
36
Serious AEs
50.0%
Results posted
Nov 2019
Primary outcome: Primary: Median Overall Survival — 13.9 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); Cisplatin (Drug); Ipilimumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoosier Cancer Research Network
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Overall Survival |
13.9 | — |
| SECONDARY Progression-Free Survival |
7.9 | — |
| SECONDARY Best Overall Response Rate |
6; 19; 10; 1 | — |
| SECONDARY Number of Adverse Events Experienced by Patients |
1; 6; 19; 10 | — |
Summary
Gemcitabine plus cisplatin is standard treatment for advanced urothelial cancer. Ipilimumab has shown intriguing activity as neoadjuvant therapy in patients with clinically localized bladder cancer undergoing radical cystectomy. The combination of gemcitabine, cisplatin, plus ipilimumab may build on the chemosensitivity of urothelial carcinoma to produce more durable responses and improved outcomes.
Eligibility Criteria
Inclusion Criteria
- Histological or cytological proof of urothelial carcinoma of the urethra, bladder, ureters, or renal pelvis.
- Advanced (clinical stage T4b, unresectable) or metastatic disease.
- Prior radiation therapy is allowed to 18 years at the time of consent.
- Written informed consent and HIPAA authorization for release of personal health information.
- Females must not be pregnant or breastfeeding.
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab.
- Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study [and for up to 26 weeks after the last dose of investigational product] in such a manner that the risk of pregnancy is minimized.
- Prior Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). Patients with other immune disorders should not be enrolled without discussion with the principal investigator.
Exclusion Criteria
- No active CNS metastases. Subjects with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis.
- No prior malignancy is allowed except for cancers that have been definitively treated with a risk of recurrence of 6 months during the past year)
Data sourced from ClinicalTrials.gov (NCT01524991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.