Status:
COMPLETED
First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 un...
Detailed Description
OUTLINE: This is a multi-center study Gemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3) Treatment during the induction phase will be administered ...
Eligibility Criteria
Inclusion
- 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 \< 25% of the bone marrow.
- Age \> 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
- 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 \< 30% based on the treating oncologists assessment.
- Patients may not have received prior systemic chemotherapy for metastatic/advanced urothelial carcinoma. Prior neoadjuvant/adjuvant therapy is permitted if completed ≥ 12 months prior to registration for protocol therapy. Prior intravesical therapy is permitted.
- No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- No underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
- No non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
- No history of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4 inhibitor or agonist.
- No known active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
- No clinically significant infections as judged by the treating investigator.
- No chronic systemic corticosteroids (defined as the equivalent of prednisone ≥ 20 mg PO daily for \> 6 months during the past year)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01524991
Start Date
January 1 2012
End Date
December 31 2018
Last Update
July 11 2022
Active Locations (8)
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1
City of Hope: Duarte
Duarte, California, United States, 91010
2
IU Health Goshen Hospital
Goshen, Indiana, United States, 46527
3
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
4
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219