Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM) (PRISMM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04447651
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : November 27, 2020
Sponsor:
Collaborators:
Vanderbilt University
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
This study is being done to see if patients with advanced or metastatic breast cancer who have a specific genetic mutation in patients' tumor (the SF3B1 mutation), are more likely to respond to immunotherapy agents that are now commercially available.

Condition or disease Intervention/treatment
Metastatic Breast Cancer SF3B1 Gene Mutation Spliceosome Mutation Other: Recommendation for treatment with immunotherapy

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Remote-Directed "Virtual" Clinical Trial in Metastatic Breast Cancer to Determine Feasibility of Evaluating Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)
Actual Study Start Date : September 17, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Patients with SF3B1 mutation
Metastatic breast cancer patients that have a SF3B1 mutation
Other: Recommendation for treatment with immunotherapy
Patients with a SF3B1 mutation will be reviewed by the molecular tumor board and treatment recommendations will be given to the patient's treating oncologist.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Metastatic breast cancer patients with a SF3B1 mutation
Criteria

Inclusion Criteria:

  • Performance status eligible for immune checkpoint blockade as determined by local physician
  • Able to demonstrate histologically proven locally advanced or metastatic breast cancer. Any receptor status is eligible (i.e. hormone receptor or human epidermal growth factor receptor 2-neu (HER2) positive or negative disease)
  • genomic testing demonstrating a spliceosome mutation (SF3B1)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04447651


Contacts
Layout table for location contacts
Contact: Hopkins Breast Trials 410-614-1361 PRISMM@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21236
Contact: HopkinsBreastTrials         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Vanderbilt University
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Principal Investigator: Cesar Santa-Maria, MD Johns Hopkins University
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT04447651    
Other Study ID Numbers: J1940
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
sequencing
metastatic breast cancer
advanced breast cancer
spliceosome mutation
immune checkpoint inhibition
immunotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases