Phase 2 Bladder Cancer Trial, Recruiting NCT05592626 Sponsor: Marengo Therapeutics, Inc. Condition: Bladder Cancer
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Phase 2 Bladder Cancer Trial, Recruiting

NCT05592626
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:

  • You have a solid tumor cancer that cannot be removed by surgery, has spread, or is at an advanced stage, and standard treatments are no longer working, don't exist, or have caused intolerable side effects — and you have had no more than three previous treatment regimens for your advanced cancer.
  • For the early phase of the trial (Phase 1), your cancer must be one of the following types: a tumor with a high number of genetic mutations (TMB-H), a tumor with a specific DNA repair problem (MSI-H/dMMR), or a tumor caused by a virus.
  • For the later phase (Phase 2), your cancer may be one of a wider range of types, including TMB-H, MSI-H/dMMR, colorectal cancer, virus-associated tumors, metastatic triple-negative breast cancer, platinum-resistant ovarian cancer, advanced prostate cancer that no longer responds to hormone therapy, stage IV or returning non-small cell lung cancer, or certain other tumor types considered likely to respond to immune-based treatment (confirm with trial site for the full list).
  • If your cancer has spread to the brain, those brain tumors must have already been treated, you must have had no symptoms for at least 14 days, you must not be receiving active treatment for the brain tumors at the time of joining, and you must not have cancer spreading along the lining of the brain or spinal cord.

Who may not be able to join:

  • You have a history of a significant autoimmune disease — though some conditions may be allowed, such as vitiligo, mild skin conditions not needing systemic treatment, hair loss, well-controlled thyroid conditions, arthritis managed only with over-the-counter anti-inflammatory tablets, or well-controlled adrenal insufficiency (confirm with trial site if you have an autoimmune condition).
  • You have had a major surgery or serious injury within the 8 weeks before starting the study treatment.
  • You have wounds from surgery or injury that have not yet fully healed.
  • You have taken immune-suppressing steroid medicines (such as prednisone at more than 10 mg per day or equivalent) within 7 days before starting the study treatment — though some exceptions may apply, and certain steroid creams, eye drops, inhalers, or nasal sprays are allowed.
  • You have significant heart or blood vessel disease, serious digestive system problems, significant ongoing inflammation, or serious lung problems (confirm with trial site for specifics).
  • You have an active serious infection — viral, bacterial, or fungal — that required treatment given through a drip or injection within 7 days before starting the study treatment.
  • You have received a live virus vaccine within 4 weeks before starting the study treatment — though standard inactivated flu vaccines are allowed.
  • You are known to be HIV positive, or have hepatitis B or C, and your condition is not well controlled.
  • You have a second, separate cancer that has not been in remission for at least 1 year — though some exceptions may apply for certain low-risk or slow-growing cancers (confirm with trial site).
  • You are pregnant, likely to become pregnant, or currently breastfeeding.
  • You have cancer that has spread to the liver, unless it has been treated and has been stable for at least 3 months.

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 22 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

Phone: +1 (617) 917-4980

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
Sponsor
Marengo Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
4 January 2023
Est. completion
1 October 2026

Where this trial is recruiting

🇨🇦 Canada 🇫🇷 France 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1; Phase 1 and 2 (Dose Escalation and Expansion): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs); Phase 2 (Dose Expansion): Percentage of Participants with Overall Objective Tumor Responses (ORR)

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: 22 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