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Platinum-based Chemotherapy

Pembrolizumab + Gemcitabine for Bladder Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Christopher Hoimes, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG PS ≤ 2; please see protocol for specific details regarding ECOG PS for each cohort
Have histologically confirmed muscle invasive disease of the urinary bladder. For subjects with tumors limited to the upper tract including renal pelvis or ureters, muscle invasive disease does not need to be pathologically proven, and a CT urogram must be performed (MRI is not acceptable to meet this criterion). To be eligible, subjects with upper tract tumors of the renal pelvis and ureter(s) must meet a high risk assessment defined as: tumor ≥ 1cm and/or hydronephrosis and/or high grade pathology and/or multifocal disease, where a radical NU approach to treat localized disease is warranted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of registration to date of death (up to 5 years)
Awards & highlights

Study Summary

This trial is for people with bladder cancer who may need surgery. It is testing a new treatment to see if it is effective and safe.

Who is the study for?
Adults over 18 with muscle invasive bladder cancer, eligible for neoadjuvant therapy and surgery. They must be physically able to participate (ECOG PS ≤ 2), have adequate organ function, and not be pregnant or breastfeeding. Participants need available tumor tissue for testing and agree to use contraception. Exclusions include other active cancers, certain heart conditions, autoimmune diseases requiring treatment, known HIV/Hepatitis B/C infections, recent immunotherapy or investigational drug use.Check my eligibility
What is being tested?
The trial is testing Pembrolizumab combined with Gemcitabine chemotherapy in patients who can/cannot receive Cisplatin before bladder cancer surgery. It's a two-part study: an initial phase Ib followed by a randomized phase II to compare the effects of these treatments based on cisplatin eligibility.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue from treatment exhaustion, blood cell count changes leading to increased infection risk or bleeding problems, potential liver or kidney function issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I have a confirmed aggressive bladder or upper urinary tract cancer.
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I can provide tissue samples for cancer analysis.
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I am over 18 years old.
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My organ functions are within normal ranges as per recent tests.
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I will use two birth control methods or avoid sex during and 120 days after the study.
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I agree to use barrier contraception during and for 120 days after the study.
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I have taken a pregnancy test that was negative within the last 3 days.
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My cancer is in stages 2 to 4 but hasn't spread to lymph nodes or other parts of my body.
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My cancer is a type of bladder cancer known as urothelial carcinoma.
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I am scheduled for surgery to remove my bladder or kidney as part of my cancer treatment plan.
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I have been on a stable dose of blood thinners like warfarin or LMWH for at least two weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of registration to date of death (up to 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration to date of death (up to 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase II: Rate of Pathologic Muscle Invasive Response (PaIR)
Phase Ib: Number of Patients with Adverse Events as a Measure of Safety and Tolerability
Secondary outcome measures
Overall Survival (OS)
Radical Cystectomy (RC) Rate
Relapse-Free Survival (RFS)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C - Phase II Cohort II:Experimental Treatment3 Interventions
Cisplatin-ineligible subjects receive gemcitabine every week every 28 days for 3 cycles. Pembrolizumab at RP2D is given every 21 days for 5 doses starting C1D8. NOTE: due to the timing of gemcitabine cycles every 4 weeks, and every 3-week dosing of pembrolizumab, there are two doses of pembrolizumab given during cycle 2: D1 and D22. Additionally, the last dose of pembrolizumab falls on what would be D8 of a 4th 'chemo' cycle; however gemcitabine is NOT GIVEN. Subjects will then have consolidative surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy.
Group II: Arm B - Phase II Cohort I:Experimental Treatment4 Interventions
Cisplatin-eligible subjects receive gemcitabine/cisplatin every 21 days, repeated for 4 cycles. (Subjects with Ccr of 50-59 mL/min must follow split dosing of cisplatin over two days) . Pembrolizumab at RP2D is given every 21 days for 5 doses starting C1D8. Note: the last dose of pembrolizumab falls on what would be day 8 of a 5th 'chemo' cycle, however gemcitabine/cisplatin is NOT GIVEN. Subjects will then have consolidative surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy.
Group III: Arm A - Phase 1b Dose Finding Cohort:Experimental Treatment3 Interventions
Cisplatin-eligible subjects will receive pembrolizumab at starting dose of 200mg (dose level 0), and/or 120mg (dose level -1) in combination with gemcitabine and cisplatin. The MTD will be the highest pembrolizumab dose level in combination with gemcitabine/cisplatin every 21 days, repeated for 4 cycles. (Subjects with Ccr of 50-59 mL/min must follow split dosing of cisplatin over two days). Once the MTD is established, this portion of the study will close and the phase II will open to cohorts I and II at the recommended phase II dose (RP2D).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Pembrolizumab
FDA approved
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

Christopher Hoimes, M.D.Lead Sponsor
Hoosier Cancer Research NetworkOTHER
68 Previous Clinical Trials
3,672 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,617 Total Patients Enrolled

Media Library

Cisplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02365766 — Phase 1 & 2
Bladder Cancer Research Study Groups: Arm B - Phase II Cohort I:, Arm A - Phase 1b Dose Finding Cohort:, Arm C - Phase II Cohort II:
Bladder Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02365766 — Phase 1 & 2
Cisplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02365766 — Phase 1 & 2

Frequently Asked Questions

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

Could you shed light on prior experiments involving Cisplatin?

"At this time, there are 1,821 active clinical trials involving Cisplatin. Of these, 414 have reached the third phase of testing and 77605 locations around the world are running studies for this drug treatment. Notably, Shanghai accounts for a large percentage of research sites."

Answered by AI

How many medical centers are currently conducting this trial?

"This clinical trial is now enrolling patients at various medical centres, such as Thomas Jefferson University: Kimmel Cancer Center in Philadelphia (Pennsylvania), Washington University: Siteman Cancer Center in Saint Louis (Missouri), and Indiana University Melvin and Bren Simon Cancer Center in Indianapolis (Indiana). There are 9 other locations."

Answered by AI

How many participants are taking part in this clinical research?

"This clinical trial has ended recruitment, with the initial post being on May 27th 2015 and the last update occurring October 3rd 2022. However, those searching for other studies may be interested in 463 transitional cell carcinoma trials or 1821 Cisplatin-related ones that are currently recruiting patients."

Answered by AI

Are there openings available to participants in this research?

"At this moment, no patients are being recruited for the trial that was initially posted on May 27th 2015 and most recently updated on October 3rd 2022. However, if you're searching for other studies to participate in, there are 463 clinical trials looking for candidates with transitional cell carcinoma, as well as 1821 Cisplatin-related medical projects actively recruiting participants."

Answered by AI

To what maladies is Cisplatin most typically administered?

"Cisplatin is often advocated for the management of refractory, relapsed mediastinal large b-cell lymphoma. This medication can also be used to address urinary bladder cancer, advanced testicular neoplasm, and small cell lung carcinoma (SCLC)."

Answered by AI
~8 spots leftby Mar 2025