First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma
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ClinicalTrials.gov Identifier: NCT01524991 |
Recruitment Status :
Active, not recruiting
First Posted : February 2, 2012
Last Update Posted : July 13, 2018
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Condition or disease | Intervention/treatment | Phase |
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Urothelial Carcinoma | Drug: Gemcitabine Drug: Cisplatin Drug: Ipilimumab | Phase 2 |
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 in six 21-day cycles. During cycles 1 and 2, gemcitabine plus cisplatin will be administered WITHOUT ipilimumab. During cycles 3-6, combination therapy with gemcitabine, cisplatin, plus ipilimumab will be administered. Patients without evidence of disease progression (by irRC) after completion cycle 6 will continue single-agent ipilimumab maintenance every 3 months.
Karnofsky performance status (KPS) ≥ 80% within 14 days prior to registration for protocol therapy.
Life Expectancy: Not Specified
Hematopoietic:
- White blood cell count (WBC) ≥ 3.5K/mm3
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelets ≥ 100K/mm3
- Absolute neutrophil count (ANC) ≥ 1.5k/mm3
Hepatic:
- Bilirubin ≤ 1.5 times x Upper Limit of Normal (ULN) (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
- Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN. NOTE: If the patient has liver metastases present, then ≤ 5 x ULN
Renal:
- Calculated creatinine clearance of ≥ 55 cc/min using the Cockcroft-Gault formula
Cardiovascular: Not Specified
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Gemcitabine, Cisplatin, Plus Ipilimumab as First-line Treatment for Patients With Metastatic Urothelial Carcinoma: Hoosier Cancer Research Network GU10-148 |
Actual Study Start Date : | January 2012 |
Actual Primary Completion Date : | July 15, 2017 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment
Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)
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Drug: Gemcitabine
Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles) Drug: Cisplatin Cisplatin 70 mg/m2 Day 1 (all cycles) Drug: Ipilimumab Ipilimumab 10 mg/kg Day 1 (start cycle 3) |
- One-Year Overall Survival [ Time Frame: 12 months ]To determine the 1-year overall survival of patients with advanced/metastatic urothelial cancer treated with gemcitabine, cisplatin, plus ipilimumab.
- Progression-Free Survival [ Time Frame: 12 months ]To determine the progression-free survival (using irRC and RECIST v1.0) of patients with advanced/metastatic urothelial carcinoma treated with gemcitabine, cisplatin, and ipilimumab.
- Best Overall Response Rate [ Time Frame: 12 months ]To determine the best overall response rate to treatment with gemcitabine, cisplatin, plus ipilimumab
- Number of Adverse Events Experienced by Patients [ Time Frame: 12 months ]To determine the safety of treatment with gemcitabine, cisplatin, plus ipilimumab.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 < 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 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 < 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524991
United States, California | |
City of Hope: Duarte | |
Duarte, California, United States, 91010 | |
United States, Indiana | |
IU Health Goshen Hospital | |
Goshen, Indiana, United States, 46527 | |
Indiana University Melvin & Bren Simon Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
IU Health Central Indiana Cancer Centers | |
Indianapolis, Indiana, United States, 46219 | |
United States, Nebraska | |
Nebraska Cancer Specialists | |
Omaha, Nebraska, United States, 68114 | |
United States, New York | |
Tisch Cancer Institute at Mount Sinai Medical Center | |
New York, New York, United States, 10029 | |
United States, Texas | |
Texas Oncology, PA | |
Dallas, Texas, United States, 75246 | |
United States, Virginia | |
Virginia Oncology Associates | |
Norfolk, Virginia, United States, 23502 |
Study Chair: | Matthew Galsky, M.D. | Hoosier Cancer Research Network |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoosier Cancer Research Network |
ClinicalTrials.gov Identifier: | NCT01524991 History of Changes |
Other Study ID Numbers: |
GU10-148 |
First Posted: | February 2, 2012 Key Record Dates |
Last Update Posted: | July 13, 2018 |
Last Verified: | July 2018 |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gemcitabine Cisplatin Antibodies, Monoclonal Antineoplastic Agents |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |