Metastatic Solid TumorPRISMMNCT04447651
Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)
An observational study of Metastatic Solid Tumor and SF3B1 Gene Mutation, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor, SF3B1 Gene Mutation, Spliceosome Mutation
- What is being tested?
- Recommendation for treatment with immunotherapy
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2020to Aug 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic solid tumor patients with a SF3B1,U2AF1 or SRSF2 mutation.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the detailed 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.
- Conditions
- Metastatic Solid Tumor, SF3B1 Gene Mutation, Spliceosome Mutation, U2AF1 Gene Mutation, SRSF2 Gene Mutation
- Being tested
- Recommendation for treatment with immunotherapy
- Keywords
- sequencing, metastatic solid tumor, spliceosome mutation, immune checkpoint inhibition, immunotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommendation for treatment with immunotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with SF3B1, U2AF1 or SRSF2 mutation | Metastatic solid tumor patients that have a SF3B1, U2AF1 or SRSF2 mutation Receives: Other: Recommendation for treatment with immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks from consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start17 Sep 2020
- Primary completion15 May 2023
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, Bristol-Myers Squibb, Avon Breast Health Access Fund
- Responsible party
- Sponsor
- Investigators
- Cesar Santa-Maria, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447651
- Sponsor's protocol ID
- J1940
- Other IDs
- IRB00186535
- Acronym
- PRISMM
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04447651
- Acronym / sponsor ID
- PRISMM / J1940
- Conditions
- Metastatic Solid Tumor, SF3B1 Gene Mutation, Spliceosome Mutation, U2AF1 Gene Mutation, SRSF2 Gene Mutation
- Keywords
- sequencing, metastatic solid tumor, spliceosome mutation, immune checkpoint inhibition, immunotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Vanderbilt University, Bristol-Myers Squibb, Avon Breast Health Access Fund
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with SF3B1, U2AF1 or SRSF2 mutation | – | Other: Recommendation for treatment with immunotherapyMetastatic solid tumor patients that have a SF3B1, U2AF1 or SRSF2 mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic solid tumor patients with a SF3B1,U2AF1 or SRSF2 mutation.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recommendation for treatment with immunotherapyPatients 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. | Other | Patients with SF3B1, U2AF1 or SRSF2 mutation |
Primary outcome
Feasibility of study as assessed by completion of study accrual within study time frame
Time frame: 2 years
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.
Feasibility of study as assessed by physician responses
Time frame: 1 year
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.
Feasibility of case review as assessed by time to issuance of recommendations
Time frame: 4 weeks from consent
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesar Santa-Maria, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Solid Tumor and SF3B1 Gene Mutation, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study as assessed by completion of study accrual within study time frame (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.