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Experimental 'Alarm' therapy aims to rev up immune system against Hard-to-Treat cancers

NCT ID NCT05338658

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial is testing a new approach called Peptide Alarm Therapy (PAT) for people with advanced solid tumors that have not responded to at least one prior treatment, including immunotherapy. PAT is injected directly into a tumor along with a standard PD-1 inhibitor drug. The goal is to see if this combination is safe and can help shrink or control the cancer. Only 21 participants who have certain immune markers (CMV and EBV positive, and a specific HLA type) will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Peptide Alarm Therapy (PAT) combined with pembrolizumab (a PD-1 inhibitor)
What this could lead to
If it works, this could offer a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early Phase I trial with only 21 participants, so it is too soon to know if it will be safe or effective. The treatment is given directly into tumors and may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must be seropositive for CMV and EBV. * Must have at least one HLA-A\*0201 allele. This screening can be performed after determining CMV and EBV seropositivity is established or, if available, from the results of previous tumor profiling by any CLIA-certified lab (i.e. Caris, FoundationOne). * 18 years or older at the time of signing the pre-screening consent. * ECOG Performance Status 0 or 1. * Adequate organ function within 14 days of study enrollment * Cardiac: New York Heart Association (NYHA) Functional Classification Class I. * Pulmonary: oxygen saturation ≥ 90% on room air. * Time between last dose of prior anti-cancer therapy and Day 1 of this study: * Chemotherapy: a minimum of 28 days since last treatment. * Targeted therapy, immunotherapy, investigational agents: a minimum of 45 days since last dose (at least 2 months for anti-VEGF) * Prior palliative radiotherapy within 7 days of start of study treatment. Participants must have recovered from all radiation-related toxicities (prior irradiation to targeted lesions is not permitted) * Must have recovered to CTCAE ≤Grade 1 from previous treatment related acute toxicities. * Persons of childbearing potential or with partners of childbearing potential must be willing to abstain from heterosexual activity or to use a highly effect form of contraception from the time of study enrollment until at least 4 months after the last dose of PD-1/PD-L1 inhibitor. * Able to understand and provide voluntary written consent prior to the performance of any research related activity. Exclusion Criteria: * Pregnant or breast feeding. * Requires therapeutic anticoagulation for which it is deemed unsafe to discontinue anticoagulation for 5 days prior to Cycle 1 through Day 7 of Cycle 1 * Class II or greater New York Heart Association Functional Classification criteria or serious cardiac arrhythmias likely to increase the risk of cardiac complications of therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmia requiring chronic therapy) * Known active CNS metastases * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Has received a live vaccine within 30 days prior to the first dose of study drug. * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to study enrollment. * Prior bone marrow and/or solid organ transplant. * Has severe hypersensitivity (≥Grade 3) to prior PD-1/PD-L1 and/or any of its excipients. * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * Has an active infection requiring systemic therapy. * Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR * Known history of active TB (Bacillus Tuberculosis) * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. * Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the treating investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Masonic Cancer Center at University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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