Could a gene mutation predict immunotherapy success? virtual trial aims to find out

NCT ID NCT04447651

Knowledge-focused Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Source: ClinicalTrials.gov ↗

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study explores whether people with metastatic solid tumors that have specific genetic mutations (SF3B1, U2AF1, or SRSF2) are more likely to respond to immunotherapy. The trial is conducted entirely online, using remote recruitment and a centralized tumor board to recommend treatments. It aims to see if this virtual approach is feasible for reaching patients and doctors who are not typically included in traditional clinical trials.

What this could mean

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

Active substance: recommendation for treatment with immunotherapy
What this could lead to: If successful, this approach could help identify which patients with certain genetic mutations are more likely to benefit from immunotherapy, potentially improving treatment decisions.
What could go wrong: This is a small, early feasibility study with only 6 participants, so results may not apply broadly. The trial focuses on whether the virtual process works, not on proving the treatment itself is effective.

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.

Participants

6 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Aug 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.

Who is studied

Metastatic solid tumor patients with a SF3B1,U2AF1 or SRSF2 mutation.

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: * Performance status eligible for immune checkpoint blockade as determined by local physician * Able to demonstrate histologically proven locally advanced or metastatic solid tumors (hematologic malignancies and lymphoma excluded) * genomic testing demonstrating a spliceosome mutation (SF3B1, U2AF1 or SRSF2) Exclusion Criteria: * Local physician determines has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Local physician determines the patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Metastatic solid tumor SF3B1 gene mutation Spliceosome mutation SRSF2 gene mutation U2AF1 gene mutation

Could a gene mutation predict immunotherapy success? virtual trial aims to find out

What the study statuses mean