Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)

NCT04447651 | Active Not Recruiting

• 2 other identifiers: J1940IRB00186535
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

SRSF2 Gene Mutation; Metastatic Solid Tumor; SF3B1 Gene Mutation; Spliceosome Mutation; U2AF1 Gene Mutation

Keywords

sequencing; metastatic solid tumor; spliceosome mutation; immune checkpoint inhibition; immunotherapy

Outcome Measures

Primary Outcomes (3)

• Feasibility of study as assessed by completion of study accrual within study time frame

  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.

  2 years

• Feasibility of study as assessed by physician responses

  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.

  1 year

• Feasibility of case review as assessed by time to issuance of recommendations

  To evaluate the feasibility of real-time case review by a centralized specialized cancer tumor board to assist in therapeutic decision making. Measured by time (days) to issuance of recommendations within 4 weeks from consent for at least 80 percent of patients.

  4 weeks from consent

Study Arms (1)

Patients with SF3B1, U2AF1 or SRSF2 mutation

Metastatic solid tumor patients that have a SF3B1, U2AF1 or SRSF2 mutation

Other: Recommendation for treatment with immunotherapy

Interventions

Recommendation for treatment with immunotherapy OTHER

Patients with a SF3B1, U2AF1 or SRSF2 mutation will be reviewed by the molecular tumor board and treatment recommendations will be given to the patient's treating oncologist.

Patients with SF3B1, U2AF1 or SRSF2 mutation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Vanderbilt University: collaborator
• Bristol-Myers Squibb: collaborator
• Avon Breast Health Access Fund: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21236, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected to: * Evaluate whether mutations detected in tumor tissue using various Clinical Laboratory Improvement Amendments (CLIA)-certified next-generation sequencing assays correlate with those found in plasma tumor DNA (ptDNA). * To evaluate changes in ptDNA from baseline to 3 months in patients with spliceosome mutations receiving immune checkpoint inhibitors (ICI) * To evaluate changes in circulating immune cells (PBMCs) from baseline to 3 months in patients with spliceosome mutations receiving ICI

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Therapeutics; Immunotherapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy

Study Officials

• Cesar Santa-Maria, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: September 17, 2020
• Primary Completion: May 15, 2023
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

US (1)