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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of registration to date of death (up to 5 years)

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of registration to date of death (up to 5 years)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Overall Survival (OS)

Radical Cystectomy (RC) Rate

Relapse-Free Survival (RFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

Gemcitabine

FDA approved

Pembrolizumab

FDA approved

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