Phase 3 Rare Disease Trial, Recruiting NCT06947928 Sponsor: TuHURA Biosciences, Inc. Condition: Rare Disease
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Phase 3 Rare Disease Trial, Recruiting

NCT06947928
Recruiting Phase 3

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 are 18 years of age or older
  • Your doctors expect you to live for at least 6 months or more
  • You are generally able to carry out daily activities with little to no limitation (confirm with trial site regarding the specific fitness level required)
  • You have been diagnosed with Merkel cell carcinoma (a rare type of skin cancer) that has either come back or cannot be removed by surgery, and is at an advanced stage (Stage III or IV)
  • You have at least one tumor that can be injected directly and is at least 3 mm in size
  • Your cancer can be measured on scans using standard medical guidelines
  • You have never previously been treated with a type of cancer drug called a checkpoint inhibitor (such as pembrolizumab, avelumab, ipilimumab, or nivolumab)
  • You are able to provide a tissue sample from a previous biopsy or surgery, or are willing to have a new biopsy taken if no previous sample is available
  • Your blood, liver, and kidney test results are within acceptable ranges as defined by the study

Who may not be able to join:

  • You have a serious uncontrolled illness, such as an active infection, uncontrolled heart failure, unstable chest pain, irregular heartbeat, or a mental health or personal situation that would make it hard to follow the study requirements
  • You have active cancer that has spread to the brain, unless it was previously treated, has been stable on scans for at least 4 weeks, has not spread further, and you are not currently taking steroids for it
  • Your Merkel cell carcinoma has come back but can still be removed by surgery
  • You have previously received chemotherapy given through the whole body (systemic chemotherapy)
  • You are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the course of the study
  • You have an active autoimmune disease (where the immune system attacks the body), though some milder conditions such as type 1 diabetes, an underactive thyroid managed with hormone replacement, or skin conditions like vitiligo or psoriasis not needing systemic treatment may still be allowed (confirm with trial site)
  • You are currently taking steroid tablets or other medicines that suppress the immune system at certain doses within 14 days of joining the study, though steroid inhalers or creams may be allowed (confirm with trial site)

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 3: approximately ~65% 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: Andrew S Brohl, MD, Collaborator

Phone: 8138756600

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 3
Sponsor
TuHURA Biosciences, Inc.
Registry
ClinicalTrials.gov
Start date
11 December 2025
Est. completion
31 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Objective response rate (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: 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