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Urothelial CarcinomaPhase 2NCT01524991

First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma

A Phase 2 study testing Gemcitabine, Cisplatin and Ipilimumab in people with Urothelial Carcinoma, run by Hoosier Cancer Research Network at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
Gemcitabine, Cisplatin and Ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
8 sitesUnited States
Study dates
Jan 2012to 31 Dec 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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)

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Texas Oncology, PA

    Dallas, Texas, 75246

  • City of Hope: Duarte

    Duarte, California, 91010

  • IU Health Goshen Hospital

    Goshen, Indiana, 46527

  • Indiana University Melvin & Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • IU Health Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • Tisch Cancer Institute at Mount Sinai Medical Center

    New York, New York, 10029

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68114

Other trials in United States

About this study

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

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.

Read the 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 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

Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)

  • CisplatinDrug

    Cisplatin 70 mg/m2 Day 1 (all cycles)

  • IpilimumabDrug

    Ipilimumab 10 mg/kg Day 1 (start cycle 3)

Study groups in NCT01524991
Study groupRoleWhat they receive
TreatmentExperimentalGemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)
Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Overall Survival

    To determine the median overall survival of patients with advanced/metastatic urothelial cancer treated with gemcitabine, cisplatin, plus ipilimumab, calculated from the date of registration until the date of final analysis, projected to be 48 months from the start of the study.

    Measured: 48 months

Secondary outcomes (3)

  1. Progression-Free Survival

    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.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression is definied by IrRC as "at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 wk apart."

    Measured: 12 months

  2. Best Overall Response Rate

    To determine the best overall response rate to treatment with gemcitabine, cisplatin, plus ipilimumab, per RECIST 1.1 criteria.

    Measured: 12 months

  3. Number of Adverse Events Experienced by Patients

    To determine the safety of treatment with gemcitabine, cisplatin, plus ipilimumab. The highest grade adverse event for each subject is presented.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completion15 Jul 2017
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01524991
Sponsor's protocol ID
GU10-148
Status last verified
Jul 2022
First submitted
30 Jan 2012
Last updated
11 Jul 2022
Data monitoring committee
Yes

Publications

  • Galsky MD, Hahn NM, Albany C, Fleming MT, Starodub A, Twardowski P, Hauke RJ, Sonpavde G, Merad M, Gnjatic S, Bhardwaj N, Chippada-Venkata U, Oh WK, Kim-Schulze S. Impact of gemcitabine + cisplatin + ipilimumab on circulating immune cells in patients (pts) with metastatic urothelial cancer (mUC). J Clin Oncol 33:5s, 2015 (suppl; abstr 4586)

  • Galsky MD, Wang H, Hahn NM, Twardowski P, Pal SK, Albany C, Fleming MT, Starodub A, Hauke RJ, Yu M, Zhao Q, Sonpavde G, Donovan MJ, Patel VG, Sfakianos JP, Domingo-Domenech J, Oh WK, Akers N, Losic B, Gnjatic S, Schadt EE, Chen R, Kim-Schulze S, Bhardwaj N, Uzilov AV. Phase 2 Trial of Gemcitabine, Cisplatin, plus Ipilimumab in Patients with Metastatic Urothelial Cancer and Impact of DNA Damage Response Gene Mutations on Outcomes. Eur Urol. 2018 May;73(5):751-759. doi: 10.1016/j.eururo.2017.12.001. Epub 2017 Dec 13.

    PubMed 29248319

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Cisplatin and Ipilimumab in people with Urothelial Carcinoma, run by Hoosier Cancer Research Network at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Overall Survival (time frame: 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01524991, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.

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