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Anti-metabolites

Pembrolizumab + Gemcitabine for Bladder Cancer

Phase 2
Recruiting
Led By Michael E Woods
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients must have had a cystoscopy or transurethral resection of bladder tumor (TURBT) with complete resection without papillary tumor and negative urinary cytology within 28 days of registration
Patients with HIV must be on effective anti-retroviral therapy with undetectable viral load within 6 months of registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights

Study Summary

This trial is testing whether adding the immunotherapy drug pembrolizumab to the chemotherapy drug gemcitabine can help to treat patients with bladder cancer that has not responded to treatment with Bacillus Calmette-Guerin (BCG).

Who is the study for?
This trial is for adults with high-grade non-muscle invasive bladder cancer that hasn't responded to BCG treatment. Candidates must have had all visible tumors removed, not be pregnant or breastfeeding, agree to birth control use, and have proper organ function. Those unfit for radical cystectomy or refusing it can join. People with certain infections, recent radiation therapy to the lungs, active autoimmune diseases, other cancers within three years, or previous treatments with similar drugs are excluded.Check my eligibility
What is being tested?
The study is testing if adding pembrolizumab (an immunotherapy drug) to gemcitabine (a chemotherapy drug) improves outcomes in patients whose bladder cancer has not improved after BCG treatment. Pembrolizumab helps the immune system fight cancer while gemcitabine works by killing or stopping tumor cells from growing.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation of organs and infusion reactions; fatigue; skin rash; digestive issues such as nausea and diarrhea; liver problems; hormonal gland problems leading to hormone deficiencies. Gemcitabine can cause blood disorders, flu-like symptoms, swelling at the injection site and hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had a complete bladder tumor removal and tests show no cancer cells in my urine.
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I have HIV, am on treatment, and my viral load has been undetectable for the last 6 months.
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My condition did not improve after initial and follow-up bladder cancer treatments.
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My bladder cancer is high risk and hasn't improved 9 months after BCG treatment.
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I cannot undergo or refuse to have major bladder surgery as advised by my doctor.
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My bladder cancer is high grade and not deeply invasive.
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I am 18 years old or older.
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I was cancer-free 6 months after starting BCG but it came back during maintenance.
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I am not pregnant and have a negative pregnancy test taken within the last week.
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I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response rate in the carcinoma in situ (CIS) subpopulation
Event-free survival at 18 months
Secondary outcome measures
Cystectomy-free survival
Duration of response (DOR)
Incidence of adverse events
+3 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, gemcitabine hydrochloride)Experimental Treatment2 Interventions
INDUCTION: Patients receive pembrolizumab IV over 25-40 minutes on day 1 of cycles 1-4. Patients also receive gemcitabine hydrochloride intravesically on days 1, 8 and 15 of cycles 1 and 2. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Beginning cycle 5, patients with no evidence of disease after induction receive pembrolizumab IV over 25-40 minutes and gemcitabine intravesically on day 1. Treatment repeats every 3 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,729 Previous Clinical Trials
40,965,871 Total Patients Enrolled
Michael E WoodsPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Bladder Cancer Clinical Trial 2023: Gemcitabine Hydrochloride Highlights & Side Effects. Trial Name: NCT04164082 — Phase 2
Bladder Cancer Research Study Groups: Treatment (pembrolizumab, gemcitabine hydrochloride)
Gemcitabine Hydrochloride (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04164082 — Phase 2
~24 spots leftby Mar 2025
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