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Alkylating agents

Gemcitabine + Cisplatin + Nivolumab for Bladder Cancer

Phase 2

Waitlist Available

Led By Matthew Galsky, MD

Research Sponsored by Matthew Galsky

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Demonstrate adequate organ function per listed criteria: Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L, Hemoglobin (Hgb) ≥ 9 g/dL, Platelets ≥ 100 x 10^9/L, Calculated creatinine clearance: Creatinine ≤ 1.5 or creatinine clearance ≥ 60 mL/min, Bilirubin ≤ 1.5 × upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL), Aspartate aminotransferase (AST) ≤ 3 × ULN, Alanine aminotransferase (ALT) ≤ 3 × ULN

Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder (i.e., ct2-4n0m0) and candidate for cystectomy as per treating physician

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat bladder cancer. It is also looking at whether or not a complete response predicts benefit for patients who choose to avoid surgery.

Who is the study for?

This trial is for adults with muscle-invasive bladder cancer who are fit for cystectomy, have not had chemo for this cancer before, and do not have active infections or other cancers. They must be able to perform daily activities with ease (ECOG ≤1) and have normal organ function. Women of childbearing age must use contraception and cannot be pregnant or breastfeeding.Check my eligibility

What is being tested?

The study tests the combination of Gemcitabine, Cisplatin, plus Nivolumab as a pre-surgery treatment in patients with muscle-invasive bladder cancer. It aims to assess safety and effectiveness while considering non-surgical options based on complete response rates.See study design

What are the potential side effects?

Potential side effects include immune-related reactions that can affect organs, infusion-related symptoms like fever or chills, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver enzyme alterations indicating liver stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood counts and kidney, liver functions are within the required ranges.

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My bladder cancer is invasive but hasn't spread beyond my pelvis, and I am a candidate for surgical removal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the ability of clinical complete response (cT0 or cTa) to predict benefit from treatment.

Determine the clinical complete response rate (cT0 or cTa) with gemcitabine, cisplatin, plus nivolumab

Secondary outcome measures

Assess Adverse Events

Bladder intact overall survival

Determine the association between a prespecified panel of genomic biomarkers and benefit from treatment in patients achieving a clinical complete response.

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gemcitabine, Cisplatin and NivolumabExperimental Treatment3 Interventions

Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Gemcitabine

2017

Completed Phase 3

~2070

Cisplatin

2013

Completed Phase 3

~1940

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiOTHER

858 Previous Clinical Trials

524,210 Total Patients Enrolled

Matthew GalskyLead Sponsor

10 Previous Clinical Trials

345 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,438 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03558087 — Phase 2

Bladder Cancer Research Study Groups: Gemcitabine, Cisplatin and Nivolumab

Bladder Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03558087 — Phase 2

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03558087 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main ambitions of this experiment?

"The purpose of this two-year trial is to assess the clinical complete response rate (cT0 or cTa) when using gemcitabine, cisplatin, and nivolumab in combination. Additionally, the research team will observe Adverse Events according to NCI CTCAE v4 guidelines as well as establish a correlation between preselected genomic biomarkers and patient benefit from treatment who achieved a clinical complete response. Finally, they seek to measure Recurrence-free survival which starts with initial treatment until death or recurrence occurs first."

Answered by AI

Has the Food and Drug Administration sanctioned Gemcitabine for use?

"Our experts at Power graded gemcitabine's safety a 2 out of 3, as Phase 2 trials are typically able to provide an indication of the medication's security. However, empirical evidence is still required to verify its efficacy."

Answered by AI

Are there numerous healthcare centers in North America conducting this experiment?

"Currently, there are 7 recruitment sites for this particular trial; these include Philadelphia, Salt Lake City and New york as well as 4 other cities. It is advisable to select the nearest location in order to reduce travel-related issues if you choose to participate in the study."

Answered by AI

What is the total number of participants being recruited for this clinical research?

"At the present, this clinical trial is not seeking participants. Initially posted on July 13th 2018 and last edited on July 7th 2022, patients are directed to other trials recruiting for bladder cancer or Gemcitabine-related studies. Currently, 373 research projects are open for enrollment in relation to cancer while 1638 investigations revolve around Gemcitabine specifically."

Answered by AI

Have there been any former experiments conducted involving Gemcitabine?

"Gemcitabine was initially researched in 1997 at City of Hope Comprehensive Cancer Center. As such, eighteen hundred and forty-eight clinical trials have been concluded thus far with sixteen hundred thirty-eight active trials occurring mainly in Philadelphia, Pennsylvania."

Answered by AI

Is enrollment still ongoing for this clinical experiment?

"According to clinicaltrials.gov, this trial is no longer attempting to recruit patients as the last edited date was July 7th 2022; however, 2011 other studies are still actively searching for participants at present time."

Answered by AI

What pathologies can be addressed through the administration of Gemcitabine?

"Gemcitabine has demonstrated efficiency in treating testicular cancer, as well as malignant neoplasms, small cell lung (SCLC) tumours and unresectable melanomas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing

Matthew Galsky 2018. "Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03558087.

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