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Immunotherapy
Patients with SF3B1, U2AF1 or SRSF2 mutation for Mutations (PRISMM Trial)
N/A
Waitlist Available
Led By Cesar Santa-Maria, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Gene Mutation
- Mutations
- Metastatic Tumor
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of case review as assessed by time to issuance of recommendations
Feasibility of study as assessed by completion of study accrual within study time frame
Feasibility of study as assessed by physician responses
Side effects data
From 2023 Phase 3 trial • 1460 Patients • NCT0414521958%
Oral pruritus
55%
Throat irritation
33%
Ear pruritus
33%
Abdominal pain upper
25%
Nasopharyngitis
21%
Lip swelling
20%
Glossodynia
19%
Nausea
17%
Taste disorder
14%
Mouth swelling
14%
Swollen tongue
13%
Diarrhoea
13%
Mouth ulceration
9%
Pharyngeal swelling
7%
Tongue ulceration
7%
Vomiting
6%
Tooth loss
5%
Pharyngitis
5%
Bronchitis
5%
COVID-19
3%
Upper respiratory tract infection
2%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
HDM SLIT-tablet (12 SQ-HDM)
Placebo SLIT-tablet
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with SF3B1, U2AF1 or SRSF2 mutationExperimental Treatment1 Intervention
Metastatic solid tumor patients that have a SF3B1, U2AF1 or SRSF2 mutation
Find a Location
Who is running the clinical trial?
Avon Breast Health Access FundUNKNOWN
Vanderbilt UniversityOTHER
710 Previous Clinical Trials
6,143,862 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
569 Previous Clinical Trials
33,362 Total Patients Enrolled
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