161 Participants Needed

Pembrolizumab + Gemcitabine for Bladder Cancer

Recruiting at 248 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received certain treatments like systemic anti-cancer therapy or radiotherapy within specific timeframes before joining the trial. It's best to discuss your current medications with the trial team.

Is the combination of Pembrolizumab and Gemcitabine safe for humans?

Pembrolizumab and Gemcitabine have been studied for safety in various conditions, including bladder cancer. Gemcitabine was well tolerated in studies with few side effects, and Pembrolizumab has been approved by the FDA for certain types of bladder cancer, indicating a recognized safety profile.12345

How is the drug Pembrolizumab + Gemcitabine unique for bladder cancer treatment?

Pembrolizumab + Gemcitabine is unique because it combines an immune checkpoint inhibitor (Pembrolizumab) with chemotherapy (Gemcitabine), offering a novel approach for patients who cannot tolerate traditional cisplatin-based treatments. This combination leverages the immune system to fight cancer while also using chemotherapy to target cancer cells directly.12356

What data supports the effectiveness of the drug combination Pembrolizumab and Gemcitabine for bladder cancer?

Pembrolizumab has been shown to improve survival in patients with advanced urothelial cancer and is approved for use in certain types of bladder cancer. Gemcitabine is commonly used in combination with other drugs for bladder cancer treatment, suggesting potential effectiveness when combined with Pembrolizumab.12356

Who Is on the Research Team?

ME

Michael E Woods

Principal Investigator

Alliance for Clinical Trials in Oncology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your platelet count is at least 100,000 per cubic millimeter.
My recent scans show no signs of cancer spread in my abdomen or pelvis.
Your hemoglobin level is at least 9.0 grams per deciliter.
See 19 more

Exclusion Criteria

I have a history of hepatitis B or an active hepatitis C infection.
I have active brain metastases or cancer in the lining of my brain.
I haven't had any cancer treatment or experimental drugs in the last 4 weeks.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Patients receive pembrolizumab IV and gemcitabine intravesically. Treatment repeats every 3 weeks for 4 cycles.

12 weeks
4 visits (in-person)

Maintenance

Patients with no evidence of disease after induction receive pembrolizumab IV and gemcitabine intravesically. Treatment repeats every 3 weeks for 12 cycles.

36 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up every 3 months for 2 years, then every 6 months for 3 years.

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Gemcitabine Hydrochloride
  • Pembrolizumab
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, gemcitabine hydrochloride)Experimental Treatment8 Interventions

Gemcitabine Hydrochloride is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Gemzar for:
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Approved in United States as Gemzar for:
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Approved in Canada as Gemzar for:
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Approved in Japan as Gemzar for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 39 patients with muscle-invasive bladder cancer, the combination of gemcitabine, cisplatin, and the immune checkpoint inhibitor pembrolizumab was effective, achieving pathologic downstaging in 56% of patients and complete pathologic response in 36%.
The treatment was generally safe, with common side effects including thrombocytopenia, anemia, and neutropenia, but no severe immune-related adverse events were reported, indicating a manageable safety profile for this neoadjuvant therapy.
Phase II Study of Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer.Rose, TL., Harrison, MR., Deal, AM., et al.[2022]
Pembrolizumab (Keytruda) has been approved by the FDA for treating high-risk, non-muscle invasive bladder cancer (NMIBC) in patients who are unresponsive to BCG therapy and are either ineligible for or have opted not to undergo cystectomy.
This approval specifically targets patients with carcinoma in situ (CIS) with or without papillary tumors, highlighting its role as a treatment option for those with limited surgical options.
FDA Approves Pembrolizumab for BCG-Unresponsive NMIBC.Wright, KM.[2021]
In the Phase III KEYNOTE-045 trial, pembrolizumab significantly improved overall survival in patients with second-line metastatic urothelial carcinoma compared to standard treatments like docetaxel, paclitaxel, and vinflunine.
Early results from the Phase II KEYNOTE-052 trial suggest that pembrolizumab is effective for first-line treatment in patients with metastatic urothelial carcinoma who are not eligible for cisplatin, leading to its FDA approval for these indications.
Pembrolizumab in the treatment of advanced urothelial cancer.Lundgren, KT., Farina, MS., Bellmunt, J.[2018]

Citations

Phase II Study of Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer. [2022]
FDA Approves Pembrolizumab for BCG-Unresponsive NMIBC. [2021]
Pembrolizumab in the treatment of advanced urothelial cancer. [2018]
Neoadjuvant Nivolumab Plus Gemcitabine/Cisplatin Chemotherapy in Muscle-Invasive Urothelial Carcinoma of the Bladder. [2023]
Cost-effectiveness of Pembrolizumab for Patients with Advanced, Unresectable, or Metastatic Urothelial Cancer Ineligible for Cisplatin-based Therapy. [2022]
Metastatic bladder cancer: advances in treatment. [2022]
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