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PD-1 Inhibitor
Combination Therapy for Breast Cancer
Verified Trial
Phase 1 & 2
Recruiting
Research Sponsored by BriaCell Therapeutics Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with persistent disease and local recurrence must not be amenable to local treatment
Is your cancer HER2 negative?
Timeline
Screening 5 days
Treatment 12 months
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a new combination therapy for patients with advanced breast cancer who have failed other treatments.
Who is the study for?
This trial is for women over 18 with Stage IV triple-negative breast cancer that can't be treated locally and who have survived past standard therapies. They must expect to live at least 4 more months, not have severe psychiatric issues or major medical conditions, no recent immunosuppressive treatments, vaccines, transplants, or autoimmune disease treatments.Check my eligibility
What is being tested?
The study tests the SV-BR-1-GM regimen combined with retifanlimab on patients with advanced breast cancer. Initially tested on a small group for safety and tolerability; if successful, expanded to more patients randomized into two groups based on treatment timing.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to monoclonal antibodies or other components like GM-CSF and Interferon. There's also a risk of immune-related adverse effects due to checkpoint inhibitors in the combination therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recurring cancer cannot be treated with surgery or radiation.
Select...
My cancer is not HER2 positive.
Select...
My cancer is in Stage IV.
Timeline
Screening ~ 5 days2 visits
Treatment ~ 12 months41 visits
Follow Up ~ through study completion, an average of 1 year
Screening ~ 5 days
Treatment ~ 12 months
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electrocardiogram
Evaluate the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with SV-BR-1-GM administered in combination with INCMGA00012 (retifanlimab) [Safety]
Evaluate the Proportion of Patients with Abnormalities in Safety Laboratory Parameters that occur in patients treated with SV-BR-1-GM administered in combination with INCMGA00012 (retifanlimab) [Safety]
Secondary outcome measures
Neoplasms
Evaluate the tumor response to SV-BR-1-GM (Non-progression) when administered in combination with INCMGA00012 (retifanlimab)
Neoplasms
Side effects data
From 2018 Phase 1 & 2 trial • 24 Patients • NCT0306694746%
Erythema, injection site
33%
Pruritis, injection site
29%
Induration, injection site
25%
Fatigue
25%
Nausea
21%
Constipation
17%
Abdominal pain
17%
Flu like symptoms
13%
Vomiting
13%
Urinary Tract Infection
13%
Diarrhea
13%
GGTP increased
13%
Injection site reaction
8%
Glucose increased
8%
Pleural Effusion
8%
Hypercalcemia
8%
AST Increased
8%
Chills
8%
Erythema Multiforme
8%
Lymphocytes Decreased
8%
Dehydration
8%
Anorexia
8%
Myalgia
8%
Back Pain
8%
Decreased appetite
8%
Dizziness
8%
Hematocrit Decreased
8%
Abdominal distension
8%
Alkaline Phosphatase Increased
8%
ALT Increased
4%
GERD
4%
Restrictive Cardiomyopathy
4%
Bone Pain
4%
Respiratory Failure
4%
Sepsis
4%
Palpitations
4%
Hyponatremia
4%
Fever
4%
Influenza A
4%
Worsening of Hypercalcemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
SV-BR-1-GM Monotherapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: SV-BR-1-GM, retifanlimab combination original sequenceExperimental Treatment4 Interventions
Subjects will be treated with the SV-BR-1-GM regimen in combination with retifanlimab with cycles every 3 weeks
Group II: SV-BR-1-GM, retifanlimab combination alternative sequenceExperimental Treatment4 Interventions
Subjects will be treated with the SV-BR-1-GM regimen in combination with retifanlimab as follows:
Cycle 1: SV-BR-1-GM only Cycle 2: resume retifanlimab on Day 2±1 Cycle 3 and beyond: retifanlimab can be administered on Day -2, Day 0, 1, 2, or 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
retifanlimab
2018
Completed Phase 1
~30
SV-BR-1-GM
2017
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
BriaCell Therapeutics CorporationLead Sponsor
2 Previous Clinical Trials
428 Total Patients Enrolled
1 Trials studying Breast Cancer
404 Patients Enrolled for Breast Cancer
Cancer Insight, LLCIndustry Sponsor
9 Previous Clinical Trials
544 Total Patients Enrolled
1 Trials studying Breast Cancer
100 Patients Enrolled for Breast Cancer
LumaBridgeUNKNOWN
3 Previous Clinical Trials
156 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is not HER2 positive.My cancer is in Stage IV.My recurring cancer cannot be treated with surgery or radiation.I have been treated for an autoimmune disease in the last 2 years.I have a history of colitis.I have severe psychiatric or major medical issues.I am a woman aged 18 or older.I haven't had chemotherapy, immunotherapy, or major surgery in the last 3 weeks.I am allergic to certain monoclonal antibodies or ingredients in retifanlimab.I have fluid buildup causing symptoms in my chest or abdomen.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I have received a transplant from another person.You have had an allergic reaction to the study drugs, GM-CSF, interferon, yeast, beef, or any ingredients used to make SV-BR-1-GM.You have had an allergic reaction to any of the proposed immunotherapies or their ingredients.You are expected to live for at least 4 more months.I have not received a live vaccine in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: SV-BR-1-GM, retifanlimab combination original sequence
- Group 2: SV-BR-1-GM, retifanlimab combination alternative sequence
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 5 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants in this medical research?
"Affirmative. According to records hosted on clinicaltrials.gov, this research project is actively recruiting participants; it was first published in March of 2018 and most recently amended November 7th 2022. The trial has 36 slots at 11 medical centres across the country."
Answered by AI
What is the aggregate size of participants in this experiment?
"Correct. The clinical trial is actively recruiting patients, as evidenced on the clinicaltrials.gov website. It was first posted March 16th 2018 and has since been updated November 7th 2022; a total of 36 participants are needed across 11 medical sites."
Answered by AI
How many centers are involved in the oversight of this research?
"At the moment, 11 clinical sites are accepting patients for this trial. These locations are spread out from Urbana to Bethesda and Jacksonville with 8 other cities in between. Therefore, selecting a clinic that is closest to you should be a priority when enrolling as it will reduce travel demands."
Answered by AI
To what use are clinicians most commonly recommending SV-BR-1-GM?
"SV-BR-1-GM is a frequently employed treatment for melanoma malignancy, as well as anthracycline-based chemotherapy, acquired immunodeficiency syndrome, and various types of lung cancer."
Answered by AI
What is the ultimate aim of this clinical experiment?
"This medical trial will measure the changes in weight that occur from treatment with SV-BR-1-GM, INCMGA00012 and epacadostat for approximately 1 year. Secondary objectives include assessing durability of response, non-progressive rate (CR, PR or SD), and duration of response."
Answered by AI
Are there other scholarly investigations that have used the SV-BR-1-GM technique?
"SV-BR-1-GM was initially trialled at City of Hope Comprehensive Cancer Center in 1997, with 1187 studies being concluded to date. Of the 862 active clinical trials happening presently, a number are situated in Urbana, Illinois."
Answered by AI
Who else is applying?
What site did they apply to?
St. Joseph Heritage Healthcare
The Center for Cancer and Blood Disorders a division of American Oncology Partners MD
Other
Manhattan Hematology Oncology Associates (MHOA)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
J'ai essaye trois autres medicaments qui n'ont pas marche c'est marrant.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Email
Average response time
- < 2 Days
Most responsive sites:
- Manhattan Hematology Oncology Associates (MHOA): < 48 hours
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