Testing the Addition of Pembrolizumab to Usual Chemotherapy for Treating Bladder Cancer That Doesn't Respond to BCG

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT04164082

Provider View

This study is exploring whether adding the drug pembrolizumab to the usual chemotherapy treatment with gemcitabine can help treat bladder cancer that hasn't responded to BCG treatment. The goal is to see if this combination can delay the return of cancer longer than gemcitabine alone.

Patient Parameters

Program Overview

This phase II trial is investigating the effects of combining pembrolizumab, an immunotherapy drug, with gemcitabine, a chemotherapy drug, in patients with non-muscle invasive bladder cancer that hasn't responded to BCG treatment. Gemcitabine works by stopping cancer cells from growing, while pembrolizumab helps the immune system attack cancer cells. The study aims to find out if this combination can keep the cancer from coming back for a longer time compared to using gemcitabine alone.

Description

The main goals of this study are to see how well the combination of gemcitabine and pembrolizumab works in treating bladder cancer that hasn't responded to BCG treatment. Researchers will look at how many patients have no signs of cancer six months after starting treatment and how long patients remain free of cancer events over 18 months.

The study will also evaluate the safety of this treatment combination and how long patients live without their cancer getting worse or needing bladder removal surgery. Researchers will also explore various biological markers to understand how they relate to treatment outcomes.

Participants will receive pembrolizumab through an IV and gemcitabine directly into the bladder over several cycles. If the cancer doesn't progress, patients will continue with maintenance treatment for up to 12 cycles. After treatment, patients will be monitored regularly for up to five years to track their health and any signs of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Have high-grade non-muscle invasive bladder cancer (Ta, T1, or CIS) that hasn't responded to BCG treatment.
  • Cancer must have persisted or returned within specific timeframes after BCG treatment.
  • Must be considered unfit for or refuse bladder removal surgery.
  • Must have confirmed bladder cancer diagnosis within 60 days before joining the study.
  • All visible tumors must be removed before joining the study.
  • Must have had a recent cystoscopy and imaging showing no cancer spread.
  • Must not be pregnant or breastfeeding and agree to use birth control during the study.
  • Be 18 years or older with a good performance status.
  • Have adequate blood counts and organ function.
  • HIV-positive patients are eligible if on effective treatment with undetectable viral load.

Exclusion Criteria

  • Have a pure variant of bladder cancer other than urothelial carcinoma.
  • Have had bladder cancer in the ureters or prostatic urethra within the last 24 months.
  • Have participated in another investigational study within four weeks before joining.
  • Have had prior treatment with certain immune therapies.
  • Have had a stem cell transplant within the last five years.
  • Have received other cancer treatments or radiation recently.
  • Have active autoimmune diseases or require immunosuppressive therapy.
  • Have a psychiatric or substance abuse disorder affecting study participation.
  • Have active infections or a history of severe lung disease.
  • Have another active cancer requiring treatment in the last three years.
  • Have active brain metastases or severe allergies to pembrolizumab.
  • Have active hepatitis B or C infections.
  • Have received live vaccines recently.

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