Phase 2 Bladder Cancer Trial, Recruiting NCT07222488 Sponsor: Merck Sharp & Dohme LLC Condition: Bladder Cancer
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Phase 2 Bladder Cancer Trial, Recruiting

NCT07222488
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with a specific type of early-stage bladder cancer (called carcinoma in situ, with or without high-risk non-muscle invasive bladder cancer), confirmed by a laboratory test on tissue samples.
  • People whose most recent bladder tumour removal surgery (a procedure called TURBT) was done within the last 12 weeks and confirmed this type of bladder cancer. For people with certain tumour types (Ta and T1), the surgery must have removed all visible tumours completely.
  • People who either: (a) have never received BCG treatment (a common bladder cancer therapy), or received it more than 2 years before their cancer returned and showed a complete response during those 2 years; or (b) received a full course of BCG treatment and had their cancer return more than 12 months but no more than 24 months after their last BCG dose.
  • People living with HIV, provided their HIV is well-controlled with antiviral medication.
  • People who have tested positive for hepatitis B, provided they have been on hepatitis B antiviral treatment for at least 4 weeks and the virus is undetectable in their blood before joining the trial.
  • People with a history of hepatitis C infection, provided the hepatitis C virus is undetectable in their blood at the time of screening.

Who may not be able to join:

  • People who have or have had more advanced bladder cancer that has grown deeper into the bladder wall or spread to other parts of the body.
  • People who currently have, or within the last 2 years have had, the same type of early-stage cancer occurring outside the bladder (such as in the urethra, ureter, or kidney).
  • People who have total bladder incontinence, an active urinary tract infection, a neurogenic bladder (nerve-related bladder problems), or a narrowing of the urethra.
  • People who have a condition that prevents them from urinating normally, or from holding their bladder for 1 to 2 hours.
  • People who have had serious heart or blood vessel problems — such as severe heart failure, unstable chest pain, a heart attack, uncontrolled irregular heartbeat, a specific abnormality on a heart tracing (QTcF interval above 470 ms), or other significant heart or stroke-related conditions — within the past 6 months.
  • People who have a history of severe dry eye syndrome, severe eyelid gland disease, or severe corneal conditions that affect the healing of the eye's surface.
  • People living with HIV who have a history of a cancer called Kaposi's sarcoma or a condition called Multicentric Castleman's Disease.
  • People who have another cancer that is currently growing or has needed active treatment within the past 3 years.
  • People who have active cancer that has spread to the brain or the lining around the brain or spinal cord.
  • People who currently have an infection that requires treatment with medicines taken throughout the body (such as antibiotics or antifungals).
  • People who have a history of non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition.
  • People who have not fully recovered from major surgery, or who still have complications from a recent surgery.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
9 December 2025
Est. completion
28 February 2029

Where this trial is recruiting

🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇴 Norway 🇪🇸 Spain Turkey (Türkiye) 🇺🇸 United States

Primary endpoints

Number of Participants Who Experience a Dose-limiting Toxicity (DLT); Number of Participants Who Experience One or More Adverse Events (AEs); Number of Participants Who Discontinue Study Treatment Due to AEs

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov