Clinical trial · Observational
Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)
A Remote-Directed "Virtual" Clinical Trial in Metastatic Solid Tumors to Determine Feasibility of Evaluating Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)
NCT04447651CI-TRIAL-00118759PRISMMactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done to see if patients with metastatic solid tumors (hematologic malignancies and lymphoma excluded) who have a specific genetic mutation in patients' tumor (the SF3B1, U2AF1 or SRSF2 mutation), are more likely to respond to immunotherapy agents that are now commercially available.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| SF3B1 Gene Mutation | — | UNRESOLVED | — |
| Spliceosome Mutation | — | UNRESOLVED | — |
| SRSF2 Gene Mutation | — | UNRESOLVED | — |
| U2AF1 Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recommendation for treatment with immunotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with SF3B1, U2AF1 or SRSF2 mutation
- description
- Metastatic solid tumor patients that have a SF3B1, U2AF1 or SRSF2 mutation
- interventionNames
- Other: Recommendation for treatment with immunotherapy
Primary outcomes (3)
- measure
- Feasibility of study as assessed by completion of study accrual within study time frame
- timeFrame
- 2 years
- description
- To evaluate the feasibility of conducting a prospective study using online recruitment tools to involve patients and physicians who are not usually served by clinical trials. Measured by enrolling 60 patients over 2 years.
- measure
- Feasibility of study as assessed by physician responses
- timeFrame
- 1 year
- description
- To evaluate the feasibility of conducting a prospective study using online recruitment tools to involve patients and physicians who are not usually served by clinical trials. Measured by obtaining responses from 80 percent of physicians within 1 year of enrollment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.