Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)

Metastatic Solid Tumor Clinical Trial

— PRISMM  

Official title:

A Remote-Directed "Virtual" Clinical Trial in Metastatic Solid Tumors to Determine Feasibility of Evaluating Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04447651
• Other study ID #: J1940
• Status: Active, not recruiting
• Start date: September 17, 2020
• Est. completion date: August 2025

Study information

• Verified date: October 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

This is a non-therapeutic study, meaning that while Johns Hopkins is providing a treatment recommendation based on participants' genetic information, participants and participants' oncologist will decide ultimately what to do, and participants' oncologist will monitor participants' day to day care while on therapy. Participation involves allowing the investigators access to participants' sequencing report and medical records, providing a blood sample (about 8 tablespoons) at baseline and possibly again after three months, and answering questionnaires. If participants join the study, a panel of experts (Johns Hopkins Molecular Tumor Board) will review participants' genetic information participants entered and make a determination regarding treatment recommendation. Blood will be collected at baseline irrespective of what treatment is recommended. If immunotherapy is recommended, the investigators may collect blood again at 3 months. Participants and participants' oncologist will ultimately decide if participants proceed with the recommend treatment or not; the recommendation made from Johns Hopkins is not binding in any way. Participants' oncologist will continue with usual care according to standard practices while participants are on therapy. The investigators will get health information and conduct questionnaires with participants and participants' oncologist to assess how participants are doing on therapy. The main risks are the discomforts of the blood draw (which are expected to be minor and not last), boredom from completing questionnaires and the risk that information may become known to people outside of the study. Participants may or may not benefit directly from being in the study and there is no payment for participation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Solid Tumor
• SF3B1 Gene Mutation
• Spliceosome Mutation

Intervention

Other:
• Recommendation for treatment with immunotherapy
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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Avon Breast Health Access Fund, Bristol-Myers Squibb, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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