Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ENROLLING_BY_INVITATION
Clinical Phase
PHASE1/PHASE2
Total Enrollment
36 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-03-16
Study Completion Date
2028-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is an open-label, phase I/II double arm study of the SV-BR-1-GM regimen in combination with retifanlimab in patients with metastatic or locally recurrent breast cancer who have failed standard therapy.
Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be an initial evaluation of the combination of the SV-BR-1-GM regimen with retifanlimab every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 12 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then an expansion cohort of up to 24 patients will be treated with that combination. These will be randomized to two regimens differing in the timing of checkpoint inhibitor administration.
Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be an initial evaluation of the combination of the SV-BR-1-GM regimen with retifanlimab every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 12 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then an expansion cohort of up to 24 patients will be treated with that combination. These will be randomized to two regimens differing in the timing of checkpoint inhibitor administration.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
NCT06878248
Breast Cancer Metastatic
Locally Advanced Breast Cancer (LABC)
Malignant Neoplasm of Breast
+3 more
RECRUITING
PHASE1
Reverse Triple Negative Immune Resistant Breast Cancer
NCT05076682
Triple-negative Breast Cancer
RECRUITING
PHASE2
Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients
NCT03650894
Breast Neoplasm Female
Breast Cancer
Breast Carcinoma
+1 more
ACTIVE_NOT_RECRUITING
PHASE2
Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line
NCT03462251
Breast Cancer
Hormone Receptor Positive Tumor
HER 2 Negative Breast Cancer
COMPLETED
PHASE3
SHR-A2102 Combined With Adebrelimab as Neoadjuvant Therapy for Early Triple-Negative Breast Cancer
NCT06819319
TNBC - Triple-Negative Breast Cancer
NOT_YET_RECRUITING
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is an open-label, phase I/II double arm study of the SV-BR-1-GM regimen in combination with retifanlimab in patients with metastatic or locally recurrent breast cancer who have failed standard therapy.
Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be an initial evaluation of the combination of the SV-BR-1-GM regimen with retifanlimab every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 12 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then an expansion cohort of up to 24 patients will be treated with that combination. These will be randomized to two regimens differing in the timing of retifanlimab administration as noted below.
The SV-BR-1-GM regimen consists of:
* Pre- SV-BR-1-GM cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation
* SV-BR-1-GM inoculation on day 0
* Interferon - at the inoculation sites 2 (±1) day post-SV-BR-1-GM
Combination therapy with retifanlimab (anti-PD-1) will be given per one of two randomized treatment arms as follows:
The SV-BR-1-GM regimen with retifanlimab will be administered every 3 weeks (± 3 days), except when approved by the Investigator in consultation with the Medical Monitor. Note that hormonal therapy (e.g., aromatase inhibitors) is permitted if ongoing, but may be added while the patient is on this study only with the Medical Monitor's approval (e.g. for hormone receptor positive patients who are deriving clinical benefit but have not achieved a CR after \>6 cycles of therapy).
Following the initial cohort, an expansion cohort of 24 patients will be randomized 1:1 into two arms with differences in initial treatment sequences: original sequence and alternative sequence. The original sequence arm will receive treatment in the same schedule as the initial cohort. Subjects in the alternative sequence will skip retifanlimab in Cycle 1, and resume retifanlimab on Day 2±1 at Cycle 2. Starting Cycle 3, retifanlimab can be administered either on Day -2/-3, Day 0 or Day 2±1. Patients will be screened to ensure they fulfill the enrollment criteria. Screening must be performed within 30 days of initiating therapy. Imaging studies must be performed within 30 days of initiating therapy for the initial 12 patients, and within 14 days for the expansion cohort (randomized portion), unless approved by the Sponsor. For subjects in expansion cohort participating in the substudy, the CD8 attenuation CT scan cannot be used for the baseline image. However, patients can be immediately scanned after the low dose attenuation scan. In the expansion cohort randomized portion of the trial, imaging must be performed within 14 days of the start of study treatment. Patients will be evaluated every 3 weeks during the study, including all safety assessments. Imaging studies will be performed every 8-12 weeks during study participation.
Pharmacodynamic assessments, including evaluation of the immune response to SV-BR-1-GM will also be performed during screening visit (substudy only), during Cycle 1, every 8-12 weeks and End of Treatment. Subsequent periodic assessments will be every 8-12 weeks from the first periodic assessment. Patients who develop progressive disease may remain on treatment for up to 6 weeks to obtain a confirmatory scan per iRECIST; or as long as the Investigator feels they are deriving clinical benefit with Medical Monitor approval. For patients who come off treatment, a final assessment will be carried out 2-4 weeks following the last dose of SV-BR-1-GM, including all safety assessments. Off-treatment subjects will continue to be followed for survival analysis every 3 months (e.g., by phone call) for at least 5 years or until death.
For the CD8 ImmunoPET sub-study, ten (10) patients will be recruited from select invited sites only, and will undergo CD8 ImmunoPET evaluation at baseline and following 3 cycles of SV-BR-1-GM therapy.
Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be an initial evaluation of the combination of the SV-BR-1-GM regimen with retifanlimab every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 12 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then an expansion cohort of up to 24 patients will be treated with that combination. These will be randomized to two regimens differing in the timing of retifanlimab administration as noted below.
The SV-BR-1-GM regimen consists of:
* Pre- SV-BR-1-GM cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation
* SV-BR-1-GM inoculation on day 0
* Interferon - at the inoculation sites 2 (±1) day post-SV-BR-1-GM
Combination therapy with retifanlimab (anti-PD-1) will be given per one of two randomized treatment arms as follows:
The SV-BR-1-GM regimen with retifanlimab will be administered every 3 weeks (± 3 days), except when approved by the Investigator in consultation with the Medical Monitor. Note that hormonal therapy (e.g., aromatase inhibitors) is permitted if ongoing, but may be added while the patient is on this study only with the Medical Monitor's approval (e.g. for hormone receptor positive patients who are deriving clinical benefit but have not achieved a CR after \>6 cycles of therapy).
Following the initial cohort, an expansion cohort of 24 patients will be randomized 1:1 into two arms with differences in initial treatment sequences: original sequence and alternative sequence. The original sequence arm will receive treatment in the same schedule as the initial cohort. Subjects in the alternative sequence will skip retifanlimab in Cycle 1, and resume retifanlimab on Day 2±1 at Cycle 2. Starting Cycle 3, retifanlimab can be administered either on Day -2/-3, Day 0 or Day 2±1. Patients will be screened to ensure they fulfill the enrollment criteria. Screening must be performed within 30 days of initiating therapy. Imaging studies must be performed within 30 days of initiating therapy for the initial 12 patients, and within 14 days for the expansion cohort (randomized portion), unless approved by the Sponsor. For subjects in expansion cohort participating in the substudy, the CD8 attenuation CT scan cannot be used for the baseline image. However, patients can be immediately scanned after the low dose attenuation scan. In the expansion cohort randomized portion of the trial, imaging must be performed within 14 days of the start of study treatment. Patients will be evaluated every 3 weeks during the study, including all safety assessments. Imaging studies will be performed every 8-12 weeks during study participation.
Pharmacodynamic assessments, including evaluation of the immune response to SV-BR-1-GM will also be performed during screening visit (substudy only), during Cycle 1, every 8-12 weeks and End of Treatment. Subsequent periodic assessments will be every 8-12 weeks from the first periodic assessment. Patients who develop progressive disease may remain on treatment for up to 6 weeks to obtain a confirmatory scan per iRECIST; or as long as the Investigator feels they are deriving clinical benefit with Medical Monitor approval. For patients who come off treatment, a final assessment will be carried out 2-4 weeks following the last dose of SV-BR-1-GM, including all safety assessments. Off-treatment subjects will continue to be followed for survival analysis every 3 months (e.g., by phone call) for at least 5 years or until death.
For the CD8 ImmunoPET sub-study, ten (10) patients will be recruited from select invited sites only, and will undergo CD8 ImmunoPET evaluation at baseline and following 3 cycles of SV-BR-1-GM therapy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Breast Cancer
Breast Neoplasm
Metastatic Breast Cancer
Breast Cancer Metastatic
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SV-BR-1-GM, retifanlimab combination original sequence
Subjects will be treated with the SV-BR-1-GM regimen in combination with retifanlimab with cycles every 3 weeks
Group Type
EXPERIMENTAL
SV-BR-1-GM
Intervention Type
BIOLOGICAL
SV-BR-1-GM inoculation intradermally at 4 sites.
Low dose cyclophosphamide
Intervention Type
DRUG
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation.
Interferon Inoculation
Intervention Type
DRUG
Post-inoculation low dose Interferon into the vaccination sites \~2 days after SV-BR-1-GM inoculation.
retifanlimab
Intervention Type
DRUG
retifanlimab 375mg administered as an intravenous infusion over 30-60 minutes every 3 weeks per randomization
SV-BR-1-GM, retifanlimab combination alternative sequence
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.
Group Type
EXPERIMENTAL
SV-BR-1-GM
Intervention Type
BIOLOGICAL
SV-BR-1-GM inoculation intradermally at 4 sites.
Low dose cyclophosphamide
Intervention Type
DRUG
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation.
Interferon Inoculation
Intervention Type
DRUG
Post-inoculation low dose Interferon into the vaccination sites \~2 days after SV-BR-1-GM inoculation.
retifanlimab
Intervention Type
DRUG
retifanlimab 375mg administered as an intravenous infusion over 30-60 minutes every 3 weeks per randomization
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SV-BR-1-GM
SV-BR-1-GM inoculation intradermally at 4 sites.
Intervention Type
BIOLOGICAL
Low dose cyclophosphamide
Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation.
Intervention Type
DRUG
Interferon Inoculation
Post-inoculation low dose Interferon into the vaccination sites \~2 days after SV-BR-1-GM inoculation.
Intervention Type
DRUG
retifanlimab
retifanlimab 375mg administered as an intravenous infusion over 30-60 minutes every 3 weeks per randomization
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Cytoxan
INCMGA00012
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Have histological confirmation of breast cancer with recurrent and/or metastatic lesions, as per the investigational site, and have failed prior therapy.
2. Patients with persistent disease and local recurrence must not be amenable to local treatment.
3. For patients with metastatic disease:
1. Human epidermal growth factor 2 (HER2) positive and estrogen receptor (ER) or progesterone receptor (PR) positive tumors: must be refractory to hormonal therapy (e.g., aromatase inhibitor, tamoxifen or fluvestrant) and previously treated with at least 2 regimens including at least two anti-HER2 agents (e.g., trastuzumab and pertuzumab).
2. HER2 negative and either ER or PR positive tumors: must be refractory to hormonal therapy (e.g. aromatase inhibitor, tamoxifen or fluvestrant) and previously treated with at least 2 chemotherapy containing regimens. (e.g. CDK4/6 inhibitor, PIK3CA inhibitor, etc)
3. HER2 positive and ER and PR negative tumors: must have failed at least 2 regimens including at least two anti-HER2 agents (e.g., trastuzumab and pertuzumab).
4. Triple Negative tumors: Must have exhausted other available therapies including prior treatment with a taxane and carboplatin.
Patients with new or progressive breast cancer metastatic to the brain will be eligible provided:
1. The brain metastases must be clinically stable (without evidence of progressive disease by imaging) for at least 4 weeks prior to first dose
2. Must have received prior radiation therapy for brain metastases or be ineligible for radiation therapy
3. There is no need for steroids and patients have not had steroids for at least 2 weeks
4. No individual tumor size is \>50 mm
5. Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
6. If surgically debulked, must be healed from surgery and at least 3 weeks have elapsed since general anesthesia
7. Patients consent to MRI studies at 3-4 week intervals until evidence of tumor regression on at least 2 imaging studies. In no case, will the interval between MRI studies be longer than 3 months. MRI studies may be introduced at any time should the patients develop new or clearly worsening symptoms and/or introduction of steroids
4. Be 18 years of age or older and female
5. Have expected survival of at least 4 months
6. Have adequate performance status (ECOG 0-1) Patients with ECOG of 2 may be admitted only with Sponsor approval.
7. Have provided written informed consent
2. Patients with persistent disease and local recurrence must not be amenable to local treatment.
3. For patients with metastatic disease:
1. Human epidermal growth factor 2 (HER2) positive and estrogen receptor (ER) or progesterone receptor (PR) positive tumors: must be refractory to hormonal therapy (e.g., aromatase inhibitor, tamoxifen or fluvestrant) and previously treated with at least 2 regimens including at least two anti-HER2 agents (e.g., trastuzumab and pertuzumab).
2. HER2 negative and either ER or PR positive tumors: must be refractory to hormonal therapy (e.g. aromatase inhibitor, tamoxifen or fluvestrant) and previously treated with at least 2 chemotherapy containing regimens. (e.g. CDK4/6 inhibitor, PIK3CA inhibitor, etc)
3. HER2 positive and ER and PR negative tumors: must have failed at least 2 regimens including at least two anti-HER2 agents (e.g., trastuzumab and pertuzumab).
4. Triple Negative tumors: Must have exhausted other available therapies including prior treatment with a taxane and carboplatin.
Patients with new or progressive breast cancer metastatic to the brain will be eligible provided:
1. The brain metastases must be clinically stable (without evidence of progressive disease by imaging) for at least 4 weeks prior to first dose
2. Must have received prior radiation therapy for brain metastases or be ineligible for radiation therapy
3. There is no need for steroids and patients have not had steroids for at least 2 weeks
4. No individual tumor size is \>50 mm
5. Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
6. If surgically debulked, must be healed from surgery and at least 3 weeks have elapsed since general anesthesia
7. Patients consent to MRI studies at 3-4 week intervals until evidence of tumor regression on at least 2 imaging studies. In no case, will the interval between MRI studies be longer than 3 months. MRI studies may be introduced at any time should the patients develop new or clearly worsening symptoms and/or introduction of steroids
4. Be 18 years of age or older and female
5. Have expected survival of at least 4 months
6. Have adequate performance status (ECOG 0-1) Patients with ECOG of 2 may be admitted only with Sponsor approval.
7. Have provided written informed consent
Exclusion Criteria
1. Concurrent or recent chemotherapy, immunotherapy (except the SV-BR-1-GM regimen), or general anesthesia/major surgery within 21 days. Patients must have recovered from all known or expected toxicities from previous systemic treatment and passed a treatment-free "washout" period of 3 weeks before starting this program (8 weeks for patients receiving nitrosourea or mitomycin). Prior immune related toxicity should not have exceeded Grade 2 (with exception of endocrinopathy).
2. Radiotherapy within 14 days of first dose of study treatment with the following caveats:
1. 28 days for pelvic radiotherapy.
2. 8 weeks for brain metastases
3. 6 months for thoracic region radiotherapy that is \> 30 Gy in 2 Gy fractions.
3. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with medical monitor.
4. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
5. History of clinical hypersensitivity to the designated combination immunotherapy, GM-CSF, Interferon, yeast, beef, or to any components used in the preparation of SV-BR-1-GM.
6. History of clinical hypersensitivity to any of the immunotherapies proposed for combination treatment or their excipients.
7. Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (e.g., antihistamines and corticosteroids) or known allergy or hypersensitivity to any component of retifanlimab or formulation components.
8. Serum creatinine OR Measured or calculated Creatinine Clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) \>1.5 × ULN OR \<30 mL/min for participants with creatinine levels \>1.5 × institutional ULN.
9. Absolute granulocyte count \<1000; platelets \<100,000; hemoglobin ≤ 8 g/L.
10. Bilirubin ≥ 1.5 × ULN unless conjugated bilirubin ≤ ULN; alkaline phosphatase \>5x upper limit of normal (ULN); ALT/AST \>2x ULN. For patients with hepatic metastases, ALT/AST \>5x ULN is exclusionary.
11. INR or PT or aPTT \> 1.5 × ULN, unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. Note: See the restricted medications list in protocol section 5.9. If an alternative cannot be found, the participant cannot be enrolled.
12. Receiving any medication listed in the prohibited medication (section 5.10 of the protocol).
13. Proteinuria \>1+ on urinalysis or \>1 gm/24hr.
14. History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful. Screening corrected QT interval (QTc) interval \>480 milliseconds is excluded (corrected by Fridericia or Bazett formula). In the event that a single QTc is \>480 milliseconds, the participant may enroll if the average QTc for the 3 ECGs is \<480 milliseconds.
16\. Left ventricular ejection fraction (LVEF as determined by cardiac echo or MUGA scan) below the normal limits of the institutions' specific testing range.
17\. New York Heart Association stage 3 or 4 cardiac disease. 18. A pericardial effusion of moderate severity or worse. 19. Symptomatic pleural effusion or ascites. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
20\. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she: agrees to take appropriate precautions to avoid becoming pregnant during the study (with at least 99% certainty, see Appendix A for permitted methods) and has a negative serum pregnancy test within 7 days prior to starting treatment.
21\. Men must have been sterile or, if they were potentially fertile/reproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.
22\. Women who are pregnant or nursing. 23. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for \> 1 year, after treatment with curative intent.
24\. Patients who are HIV positive (by self-report) and have clinical or laboratory features indicative of AIDS.
25\. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
25\. Has had an allogeneic tissue/solid organ transplant. 26. Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
27\. Patients with a history of colitis. 28. Has a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
29\. Known active HBA, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization).
30\. Active infections requiring systemic therapy.
a. All antibiotic therapy within 28 days of initiating treatment must be recorded 31. Has a known history of active tuberculosis (TB; Bacillus tuberculosis). 32. Patients with severe psychiatric (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator in consultation with the medical monitor.
33\. Has received a live vaccine within 28 days of the planned start of study drug. Note: examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live-attenuated vaccines and are not allowed.
34\. Patients may not be on a concurrent clinical trial, unless approved by the Investigator.
2. Radiotherapy within 14 days of first dose of study treatment with the following caveats:
1. 28 days for pelvic radiotherapy.
2. 8 weeks for brain metastases
3. 6 months for thoracic region radiotherapy that is \> 30 Gy in 2 Gy fractions.
3. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with medical monitor.
4. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
5. History of clinical hypersensitivity to the designated combination immunotherapy, GM-CSF, Interferon, yeast, beef, or to any components used in the preparation of SV-BR-1-GM.
6. History of clinical hypersensitivity to any of the immunotherapies proposed for combination treatment or their excipients.
7. Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (e.g., antihistamines and corticosteroids) or known allergy or hypersensitivity to any component of retifanlimab or formulation components.
8. Serum creatinine OR Measured or calculated Creatinine Clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) \>1.5 × ULN OR \<30 mL/min for participants with creatinine levels \>1.5 × institutional ULN.
9. Absolute granulocyte count \<1000; platelets \<100,000; hemoglobin ≤ 8 g/L.
10. Bilirubin ≥ 1.5 × ULN unless conjugated bilirubin ≤ ULN; alkaline phosphatase \>5x upper limit of normal (ULN); ALT/AST \>2x ULN. For patients with hepatic metastases, ALT/AST \>5x ULN is exclusionary.
11. INR or PT or aPTT \> 1.5 × ULN, unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. Note: See the restricted medications list in protocol section 5.9. If an alternative cannot be found, the participant cannot be enrolled.
12. Receiving any medication listed in the prohibited medication (section 5.10 of the protocol).
13. Proteinuria \>1+ on urinalysis or \>1 gm/24hr.
14. History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful. Screening corrected QT interval (QTc) interval \>480 milliseconds is excluded (corrected by Fridericia or Bazett formula). In the event that a single QTc is \>480 milliseconds, the participant may enroll if the average QTc for the 3 ECGs is \<480 milliseconds.
16\. Left ventricular ejection fraction (LVEF as determined by cardiac echo or MUGA scan) below the normal limits of the institutions' specific testing range.
17\. New York Heart Association stage 3 or 4 cardiac disease. 18. A pericardial effusion of moderate severity or worse. 19. Symptomatic pleural effusion or ascites. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
20\. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she: agrees to take appropriate precautions to avoid becoming pregnant during the study (with at least 99% certainty, see Appendix A for permitted methods) and has a negative serum pregnancy test within 7 days prior to starting treatment.
21\. Men must have been sterile or, if they were potentially fertile/reproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.
22\. Women who are pregnant or nursing. 23. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for \> 1 year, after treatment with curative intent.
24\. Patients who are HIV positive (by self-report) and have clinical or laboratory features indicative of AIDS.
25\. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
25\. Has had an allogeneic tissue/solid organ transplant. 26. Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
27\. Patients with a history of colitis. 28. Has a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
29\. Known active HBA, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization).
30\. Active infections requiring systemic therapy.
a. All antibiotic therapy within 28 days of initiating treatment must be recorded 31. Has a known history of active tuberculosis (TB; Bacillus tuberculosis). 32. Patients with severe psychiatric (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator in consultation with the medical monitor.
33\. Has received a live vaccine within 28 days of the planned start of study drug. Note: examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live-attenuated vaccines and are not allowed.
34\. Patients may not be on a concurrent clinical trial, unless approved by the Investigator.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LumaBridge
INDUSTRY
Sponsor Role
collaborator
BriaCell Therapeutics Corporation
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
George E Peoples, MD, FACS
Role: STUDY_DIRECTOR
LumaBridge LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Site Status
St. Joseph Heritage Healthcare
Santa Rosa, California, United States
Site Status
Mayo Clinic Florida
Jacksonville, Florida, United States
Site Status
University of Miami/Sylvester at Plantation
Plantation, Florida, United States
Site Status
Carle Cancer Institute
Urbana, Illinois, United States
Site Status
Cancer Center of Kansas (CCK)
Wichita, Kansas, United States
Site Status
The Center for Cancer and Blood Disorders a division of American Oncology Partners MD
Bethesda, Maryland, United States
Site Status
St Vincent-Frontier Cancer Center
Billings, Montana, United States
Site Status
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Site Status
Overlook Medical Center Oncology Research, Atlantic Health System
Summit, New Jersey, United States
Site Status
Manhattan Hematology Oncology Associates (MHOA)
Manhattan, New York, United States
Site Status
Mary Crowley Cancer Research
Dallas, Texas, United States
Site Status
Tranquil Clinical Research
Webster, Texas, United States
Site Status
Hematology-Oncology Associates of Fredericksburg, Inc
Fredericksburg, Virginia, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Related Links
Access external resources that provide additional context or updates about the study.
http://briacell.com/
Sponsor Website
http://www.lumabridge.com/
CRO Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BRI-ROL-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases
NCT06210438
NOT_YET_RECRUITING
PHASE2
Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-173/KEYNOTE-173)
NCT02622074
COMPLETED
PHASE1
Ruxolitinib W/ Preop Chemo For Triple Negative Inflammatory Brca
NCT02041429
COMPLETED
PHASE1/PHASE2
SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC
NCT06627712
RECRUITING
PHASE3
A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
NCT06926920
RECRUITING
PHASE1/PHASE2
Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis
NCT06718933
RECRUITING
PHASE1/PHASE2
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer
NCT03351231
TERMINATED
PHASE1/PHASE2
Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer
NCT02876302
ACTIVE_NOT_RECRUITING
PHASE2
Botensilimab, Balstilimab, and SBRT in Colorectal Cancer
NCT07128355
NOT_YET_RECRUITING
EARLY_PHASE1
A Two-cohort Study of SHR-A1811 in the Treatment of HER2-positive Breast Cancer With Brain Metastases
NCT07177950
NOT_YET_RECRUITING
PHASE1/PHASE2
Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment
NCT05132790
ACTIVE_NOT_RECRUITING
NA
Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer
NCT01623349
COMPLETED
PHASE1
Sacituzumab Govitecan In TNBC
NCT04230109
RECRUITING
PHASE2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
NCT07208149
RECRUITING
PHASE1/PHASE2
SHR-A1811 Combine With Pyrotinib for Locally Advanced/Metastatic HER2 Positive Breast Cancer
NCT07132242
NOT_YET_RECRUITING
PHASE2
A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies
NCT04927884
TERMINATED
PHASE1/PHASE2
Pembrolizumab and Ruxolitinib Phosphate in Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer
NCT03012230
COMPLETED
PHASE1
Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC
NCT03289819
COMPLETED
PHASE2
Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer
NCT07107217
NOT_YET_RECRUITING
PHASE2
LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer
NCT04032080
COMPLETED
PHASE2
Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
NCT05491226
ACTIVE_NOT_RECRUITING
PHASE2
A Phase II Study of Irinotecan in 3 Line or More Therapy in Local Recurrence or Metastatic Breast Cancer
NCT02030678
UNKNOWN
PHASE2
Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax
NCT01570036
COMPLETED
PHASE2
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC
NCT03184558
TERMINATED
PHASE2
Real-world Study of Sacituzumab Govitecan Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer
NCT07018427
ACTIVE_NOT_RECRUITING