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Experimental combo therapy for advanced cancer shows promise but trial ends early

NCT ID NCT05846646

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new treatment for people with non-small cell lung cancer or kidney cancer that had spread to up to six spots in the body. The treatment combined a special type of radiation therapy (PULSAR) with immunotherapy drugs (pembrolizumab or nivolumab), with or without an experimental drug called IMSA101 that boosts the immune system. The goal was to see if adding IMSA101 made the treatment safer and more effective. The trial was stopped early after enrolling only 6 participants, so results are limited.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

6 people

The number who actually took part.

Started

Jun 2023

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Male or female patients ≥ 18 years of age 2. Signed informed consent and mental capability to understand the informed consent 3. Histologically or cytologically documented NSCLC or RCC with radiographically documented presence of ≤ 6 metastatic lesions consistent with the diagnosis of "oligometastatic" disease 4. Patient's disease must be evaluable per RECIST Version 1.1 5. All metastatic lesions amenable to administration of radiotherapy, at the discretion of the investigator 6. Must have at least one single pre-defined lesion/lesion site (longest diameter ≥ 10 mm and ≤ 50 mm) suitable for intra-tumoral injection 7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 8. Electrocardiogram (ECG) without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator 9. Acceptable organ and marrow function as defined below: * Absolute neutrophil count (ANC) \> 1,500 cells/μL * Platelets \> 50,000 cells/μL * Total bilirubin ≤ 1.5 times (×) the upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN. If liver metastases are present, AST/ALT \< 5 × ULN * Serum creatinine \< 1.5 mg/dL and a measured creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula * Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 × ULN 10. Women of child-bearing potential (defined as a female who has experienced menarche and who has not undergone successful surgical sterilization \[hysterectomy, bilateral salpingectomy, or bilateral oophorectomy\]) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months with an appropriate clinical profile at the appropriate age, eg, greater than 45 years) must have a negative serum pregnancy test prior to first dose of study treatment 11. Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study Exclusion Criteria: 1. Prior disease progression through programmed cell death ligand 1 (PD-L1 or PD-1)-targeted immunotherapy 2. Prior receipt of stimulator of interferon genes (STING) agonist 3. Prior receipt of therapeutic radiotherapy to the lesions intended for PULSAR treatment 4. Anti-cancer therapy, except pembrolizumab and nivolumab, within 4 weeks or \< 5 half-lives of the first dose of study treatment 5. Existence of primary tumor that requires therapeutic treatment beyond the provided immune checkpoint inhibitor drug 6. Failure to recover, to Grade 1 or less, from clinically significant AEs due to prior anti-cancer therapy, as judged by the investigator 7. Previous life-threatening (Grade 4) immune-related adverse event (irAE) 8. Existence of actionable mutations that may be eligible for mutation-targeted drug that represents standard-of-care therapy 9. Presence of brain metastases 10. Baseline prolongation of QT/corrected QT (QTc) interval (QTc interval \> 470) 11. Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations) that in the opinion of the investigator would limit compliance with study requirements 12. Women who are pregnant or breastfeeding 13. Sponsor reserves the right to exclude any patient from the study on the basis of pre-study medical histories, physical examination findings, clinical laboratory results, prior medications, or other entrance criteria

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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.

Contacts and locations

Locations

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030, United States

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618, United States

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112, United States

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • Louis Stokes Cleveland VA Medical Center

    Cleveland, Ohio, 44106, United States

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903, United States

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.