Trial Title:
Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
NCT ID:
NCT06072612
Condition:
Breast Cancer
Metastatic Breast Cancer
Breast Neoplasm
Breast Cancer Metastatic
End Stage Cancer
Conditions: Official terms:
Breast Neoplasms
Interferons
Cyclophosphamide
Conditions: Keywords:
Breast
metastatic
advanced
cancer
late line
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
SV-BR-1-GM
Description:
SV-BR-1-GM is an experimental, allogeneic, whole cell breast tumor cell line stably
transfected with the CSF2 gene (encoding GM-CSF) to secrete GM-CSF in vivo to
consequently augment dendritic cell activity
Arm group label:
Bria-IMT Regimen + CPI
Arm group label:
Bria-IMT Regimen Alone
Other name:
Part of the Bria-IMT regimen
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Cyclophosphamide is an alkylating agent with indications for treatment of malignant
diseases including breast cancer. Cyclophosphamide (Cytoxan) 300 mg/m2 I.V., single dose,
will be given to patients assigned to the SV-BR-1-GM. Cyclophosphamide will be
administered 2-3 days prior to SV-BR-1-GM inoculations.
Arm group label:
Bria-IMT Regimen + CPI
Arm group label:
Bria-IMT Regimen Alone
Intervention type:
Drug
Intervention name:
Interferon infiltration of the inoculation site
Description:
Interferon is a cytokine released by cells to regulate immune responses to viral
infections. For this study, 0.1 mcg Pegasys per injection site (x 4 injection sites) will
be administered.
Arm group label:
Bria-IMT Regimen + CPI
Arm group label:
Bria-IMT Regimen Alone
Intervention type:
Drug
Intervention name:
Retifanlimab
Description:
Retifanlimab is a checkpoint inhibitor. A total dose of 375mg will be administered at
first cycle on or about day +2 (+/-1d). In all other cycles, Retifanlimab is permitted to
be administered between Day -2/-3 to Day 2±1 of the cycle based on the convenience of the
patients and the clinical sites. However once the timing of the CPI is chosen for C1, it
must be given on the same day thereafter throughout the trial.
Arm group label:
Bria-IMT Regimen + CPI
Intervention type:
Drug
Intervention name:
Treatment of Physician's Choice
Description:
Patients in the TPC arm of the study will be treated with one or a combination of the
following: carboplatin, taxanes, capecitabine, gemcitabine, vinorelbine or eribulin in
accordance with the investigators and institutional standard of care. For HER2+ patients,
a HER2-targeted agent of the physician's choice can be part of TPC.
Arm group label:
Treatment of Physician's Choice
Summary:
This is a multicenter randomized, open label study to evaluate overall survival with the
Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus
Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally
recurrent breast cancer (aMBC) patients with no approved alternative therapies available.
Detailed description:
This is a multicenter randomized, open label study to evaluate overall survival with the
Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus
Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally
recurrent breast cancer (aMBC) patients with no approved alternative therapies available.
A secondary objective will be to evaluate the activity of the Bria-IMT regimen alone in
comparison with the Bria-IMT regimen in combination with CPI.
Initial randomization will be 1:1:1 to the Bria-IMT regimen + CPI (combination therapy),
TPC, and the Bria-IMT regimen alone (monotherapy). After the first 150 patients have
enrolled in the study, the monotherapy arm will be discontinued and patients allowed to
cross over to the combination therapy if needed. Randomization will continue 1:1 between
the combination therapy vs TPC.
For the Bria regimen +/- CPI arms, treatment cycles occur every 3 weeks. TPC cycle
details will be according to the site's SOC. In the absence of progressive disease or
major safety issues, the patient will continue with therapy cycles, with imaging
assessment every 6 weeks x2 then every 8 weeks thereafter.
The Bria-IMT regimen includes:
Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into
4 inoculations Day 1-3 CPI infusion plus interferon intra-dermally within each Bria-IMT
inoculation site
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Be ≥ 18 years of age.
2. Have signed informed consent.
3. Have histological confirmation of breast cancer with either locally recurrent
unresectable and/or metastatic lesions, and have failed prior therapy:
- Patients with persistent disease and local recurrence must not be amenable to
local treatment.
- For patients with metastatic disease, late-stage MBC with no meaningful
alternative therapies available and the following class specific treatment
histories:
1. Human epidermal growth factor 2 (HER2) positive must be previously treated
with at least 3 regimens containing at least two anti-HER2 and at least
one chemotherapy containing regimen.
2. Estrogen receptor (ER), progesterone receptor (PR) positive tumors: must
be refractory to hormonal therapy demonstrated by progression on at least
2 hormonal agents in 2 separate lines of hormone directed therapy.
3. Triple Negative tumors: Must have exhausted all curative intent therapies
including at least 2 prior chemotherapy regimens, which can include
regimens in neoadjuvant and adjuvant settings.
4. Cancers with known germline or genomic actionable targets, e.g. g/mBRCA,
must have been treated with all tumor directed indicated treatment e.g.
PARPi, if tolerated.
5. HER2 low patients, in addition to the appropriate therapies based on ER/PR
status and germline or genomic actionable targets, must also have received
at least one HER2-targeted agent approved for treatment of HER2 low
patients.
6. HER2 negative tumors must be refractory to hormonal therapy (if indicated)
and previously treated with at least 2 chemotherapy regimens.
7. Patients with new or progressive breast cancer metastatic to the brain
will be eligible provided:
- The brain metastases must be clinically stable (without evidence of
progressive disease by imaging for at least 4 weeks prior to first
dose)
- There is no need for steroids and patients have not had steroids for
at least 2 weeks prior to the first dose
- Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
- If surgically debulked, must be healed with at least 3 weeks since
surgery prior to the first dose
4. Has expected survival of at least 4 months.
5. ECOG performance status of 0, 1 or 2
Exclusion Criteria:
1. Concurrent or recent chemotherapy, immunotherapy or major surgery within 21 days
prior to the first dose.
2. Radiotherapy within 14 days of the first dose of study treatment.
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).
4. Any toxicity to prior CPI that was grade 3 or higher unless it has been successfully
treated (e.g. hypothyroidism or hypopituitarism treated with replacement therapy), .
5. Toxicity to prior CPI that has not resolved to grade 1 or less except for stable
asymptomatic endocrinopathies.
6. History of clinical hypersensitivity to the designated therapy as specified in the
protocol, including the proposed TPC, beef, or to any components used in the
preparation of SV- BR-1-GM.
7. History of hypersensitivity to any of the therapies proposed for treatment in this
study.
8. Serum creatinine OR Measured OR calculated Creatinine Clearance (CrCl) (GFR can also
be used in place of creatinine or CrCl) >2.0 × ULN or <30 mL/min for participants
with creatinine levels >2.0 × institutional ULN.
9. Absolute granulocyte count <1000; platelets <80,000; hemoglobin ≤ 7 g/L.
10. Bilirubin ≥ 2 × ULN unless conjugated bilirubin ≤ ULN; alkaline phosphatase >5x
upper limit of normal (ULN); ALT/AST >3x ULN. For patients with hepatic metastases,
ALT/AST >5x ULN is exclusionary.
11. INR or PT or aPTT > 1.8 × ULN, unless the participant is receiving anticoagulant
therapy as long as PT or aPTT is within therapeutic range of intended use of
anticoagulants.
12. Receiving any medication listed in the prohibited medication section of the
protocol.
13. Proteinuria >2+ on urinalysis
14. A 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.
15. New York Heart Association stage 3 or 4 cardiac disease.
16. A pericardial effusion of moderate severity or worse.
17. Symptomatic pleural effusion or ascites. A participant who is clinically stable
following treatment for these conditions (including therapeutic thoraco- or
paracentesis) is eligible.
18. 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 and has a negative serum
pregnancy test within 7 days prior to starting treatment.
19. 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.
20. Women who are pregnant or nursing.
21. Known additional malignancy that is progressing or requires active treatment, or
history of other malignancy within 2 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.
22. Patients who have uncontrolled HIV or have clinical or laboratory features
indicative of AIDS.
23. 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.
24. Have an active autoimmune disease that has required systemic treatment in past year
(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.
25. Known active HAV, 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).
26. Active infections requiring systemic therapy within the past 14 days.
27. Patients with severe psychiatric disease (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.
28. Has received a live vaccine within 28 days of the first dose of study drug.
29. Patients may not be on a concurrent clinical trial, unless approved by the
Investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hoag Hospital Center
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Contact:
Last name:
Keeva Bromley
Email:
keeva.bromley@hoag.org
Investigator:
Last name:
Chaitali Nangia, MD
Email:
Principal Investigator
Facility:
Name:
Hoag Hospital Irvine
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kevva Bromey
Email:
keeva.bromley@hoag.org
Investigator:
Last name:
Chaitali Nangia, MD
Email:
Principal Investigator
Facility:
Name:
St. John's Cancer Center
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pamela Torres, CCRC
Email:
pamela.torres@providence.org
Investigator:
Last name:
Parvin Peddi, MD
Email:
Principal Investigator
Facility:
Name:
Advent Health - Orlando
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Young, CCRC
Phone:
407-303-2284
Email:
ashley.young@adventhealth.com
Contact backup:
Last name:
Valeria BURKOVSKAYA, CCRC
Phone:
407-303-2283
Email:
valeria.burkovskaya@adventhealth.com
Investigator:
Last name:
Carlos Alemany, MD
Email:
Principal Investigator
Facility:
Name:
AMR Kansas City Oncology
Address:
City:
Kansas City
Zip:
66204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Ross, CCRC
Phone:
913-386-7556
Email:
jennifer.ross@amrllc.com
Contact backup:
Last name:
Jason Huntington, Site Manager
Phone:
(913) 386-7556
Investigator:
Last name:
Jaswinder Singh, MD
Email:
Principal Investigator
Facility:
Name:
Care Access-Marrero
Address:
City:
Marrero
Zip:
70072
Country:
United States
Status:
Recruiting
Contact:
Last name:
William Robinson, RN
Phone:
351-227-7173
Email:
William.robinson@careaccess.com
Investigator:
Last name:
Shibu Varughese, MD
Email:
Principal Investigator
Facility:
Name:
The Center for Cancer and Blood Disorders a division of American Oncology Partners, P.A.
Address:
City:
Bethesda
Zip:
20817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jenelle Larkin, CCRC
Phone:
301-571-0019
Phone ext:
69355
Email:
Jenelle.Larkin@aoncology.com
Contact backup:
Last name:
Natalie Bongiorno, RN, MSHS
Phone:
301-571-2016
Email:
Natalie.Bongiorno@aoncology.com
Investigator:
Last name:
Ralph Boccia, MD
Email:
Principal Investigator
Facility:
Name:
Nebraska Cancer Specialists
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Cordes, CCRC
Phone:
402-691-6970
Email:
hcordes@nebraskacancer.com
Contact backup:
Last name:
Scott Degenhardt
Phone:
402-691-5257
Email:
sdegenhardt@nebraskacancer.com
Investigator:
Last name:
Geetha Palaniappan, MD
Email:
Principal Investigator
Facility:
Name:
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Babylon)
Address:
City:
Babylon
Zip:
11702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Gianelli
Phone:
855-528-7322
Email:
lgianelli@nycancer.com
Investigator:
Last name:
Richard Zuniga, MD
Email:
Principal Investigator
Facility:
Name:
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Brox)
Address:
City:
Bronx
Zip:
10469
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Gianelli
Phone:
855-528-7322
Email:
lgianelli@nycancer.com
Investigator:
Last name:
Richard Zuniga, MD
Email:
Principal Investigator
Facility:
Name:
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(New Hyde Park)
Address:
City:
New Hyde Park
Zip:
11042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Gianelli
Email:
lgianelli@nycancer.com
Investigator:
Last name:
Richard Zuniga, MD
Email:
Principal Investigator
Facility:
Name:
Manhattan Hematology /Oncology Associates
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patricia Mccullough, RN
Phone:
212-689-6791
Email:
patriciarose13@gmail.com
Investigator:
Last name:
Alec Goldenberg, MD
Email:
Principal Investigator
Facility:
Name:
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (NY)
Address:
City:
New York
Zip:
10028
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Gianelli
Email:
lgianelli@nycancer.com
Investigator:
Last name:
Richard Zuniga, MD
Email:
Principal Investigator
Facility:
Name:
New York Cancers & Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Patchogue)
Address:
City:
Patchogue
Zip:
11772
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Bilka, LPN
Phone:
631-675-5075
Email:
research@nycancer.com
Investigator:
Last name:
Richard Zuniga, MD
Email:
Principal Investigator
Investigator:
Last name:
Gurmohan Syali, MD
Email:
Sub-Investigator
Facility:
Name:
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Port Jefferson Station2)
Address:
City:
Port Jefferson Station
Zip:
11776
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Gianelli
Phone:
855-528-7322
Email:
lgianelli@nycancer.com
Investigator:
Last name:
Richard Zuniga, MD
Email:
Principal Investigator
Facility:
Name:
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(Port Jefferson Station1)
Address:
City:
Port Jefferson Station
Zip:
11776
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Gianelli
Phone:
855-528-7322
Email:
lgianelli@nycancer.com
Investigator:
Last name:
Richard Zuniga, MD
Email:
Principal Investigator
Facility:
Name:
New York Cancers & Blood Specialists
Address:
City:
Port Jefferson Station
Zip:
11776
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Gianelli
Phone:
855-528-7322
Email:
lgianelli@nycancer.com
Contact backup:
Last name:
Laura Brady-Parisi, LPN, LPN
Phone:
631-675-5075
Email:
lbrady@nycancer.com
Investigator:
Last name:
Richard Zuniga, MD
Email:
Principal Investigator
Facility:
Name:
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Riverhead)
Address:
City:
Riverhead
Zip:
11901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Gianelli
Email:
lgianelli@nycancer.com
Investigator:
Last name:
Richard Zuniga, MD
Email:
Principal Investigator
Facility:
Name:
Gabrail Cancer & Research Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Smith, RN
Phone:
330-492-3345
Email:
csmith@gabrailcancercenter.com
Investigator:
Last name:
Nashat Gabrail, MD
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariah Branem, CCRC
Phone:
866-320-4573
Email:
branemm@ccf.org
Investigator:
Last name:
Azka Ali, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melissa Melendez-Salazar, RN
Phone:
214-370-1038
Email:
melissa.melende-salazar@usoncology.com
Contact backup:
Last name:
Jessica Medina, CCRC
Phone:
214-370-1989
Email:
jessica.medina@usoncology.com
Investigator:
Last name:
Joyce O'Shaughnessy, MD
Email:
Principal Investigator
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75251
Country:
United States
Status:
Recruiting
Contact:
Last name:
Akhil Valiyil, CCRC
Phone:
972-566-3061
Email:
avaliyil@marycrowley.org
Contact backup:
Last name:
Angela Hotchkiss
Phone:
214-658-1958
Email:
ahotchkiss@marycrowley.org
Investigator:
Last name:
Minal Barve, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - Fredericksburg
Address:
City:
Fredericksburg
Zip:
78624
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brenda Travieso
Email:
Brenda.Travieso@usoncology.com
Investigator:
Last name:
Emmalind Aponte, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - Harlingen
Address:
City:
Harlingen
Zip:
78550
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nereida Salinas
Email:
nereida.salinas@usoncology.com
Investigator:
Last name:
Alvaro Restrepo, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology McAllen
Address:
City:
McAllen
Zip:
78503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nereida Salinas, RN
Phone:
956-687-5150
Email:
nereida.salinas@usoncology.com
Investigator:
Last name:
Alvaro Restrepo, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology, New Braunfels
Address:
City:
New Braunfels
Zip:
78130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brenda Travieso
Email:
Brenda.Travieso@usoncology.com
Investigator:
Last name:
Emmalind Aponte, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology-San Antonio Cancer Care
Address:
City:
San Antonio
Zip:
78216
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shannon Syring, RN
Phone:
210-419-2608
Email:
shannon.syring@usoncology.com
Contact backup:
Last name:
Norma Norris, RN
Phone:
210-595-5613
Email:
norma.norris@usoncology.com
Investigator:
Last name:
Emmalind Aponte, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - San Antonio Northeast
Address:
City:
San Antonio
Zip:
78217
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brenda Travieso
Email:
Brenda.Travieso@usoncology.com
Investigator:
Last name:
Emmalind Aponte, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - San Antonio Stone Oak
Address:
City:
San Antonio
Zip:
78258
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brenda Travieso
Email:
Brenda.Travieso@usoncology.com
Investigator:
Last name:
Emmalind Aponte, MD
Email:
Principal Investigator
Facility:
Name:
Tranquil Clinical Research
Address:
City:
Webster
Zip:
77598
Country:
United States
Status:
Recruiting
Contact:
Last name:
Veronica D. Mohammed, RN
Phone:
713-907-6054
Email:
veronicam@tranquilityresearch.com
Contact backup:
Last name:
Patricia Roark, RN
Phone:
346-435-9438
Email:
patriciar@tranquilityresearch.com
Investigator:
Last name:
John Knecht, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - Weslaco
Address:
City:
Weslaco
Zip:
78596
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nereida Salinas, RN
Email:
nereida.salinas@usoncology.com
Investigator:
Last name:
Alvaro Restrepo, MD
Email:
Principal Investigator
Facility:
Name:
Hematology-Oncology Associates of Fredericksburg, Inc
Address:
City:
Fredericksburg
Zip:
22408
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Lawrence, RN, OCN
Phone:
540-371-0079
Phone ext:
149
Email:
alawrence@hoafredericksburg.com
Contact backup:
Last name:
Amber Spurley, RN
Phone:
540-371-0079
Email:
research@hoafredericksburg.com
Investigator:
Last name:
Christopher N. Vaughn, MD
Email:
Principal Investigator
Facility:
Name:
Cancer Care Northwest
Address:
City:
Spokane Valley
Zip:
99218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ronaye Wagner, RN, MSN
Phone:
509-228-1680
Email:
Ronaye.wagner@ccnw.net
Contact backup:
Last name:
Bethany Giachetti, BS, CCRC
Phone:
509-228-1684
Email:
Bethany.giachetti@ccnw.net
Investigator:
Last name:
Kristine Rinn, MD
Email:
Principal Investigator
Facility:
Name:
Cancer Care Northwest-1 (601 S. Sherman)
Address:
City:
Spokane
Zip:
99202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ronaye Wagner
Email:
Ronaye.wagner@ccnw.net
Investigator:
Last name:
Kristine Rinn, MD
Email:
Principal Investigator
Facility:
Name:
Cancer Care Northwest_2 (605 E. Holland)
Address:
City:
Spokane
Zip:
99218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ronaye Wagner
Email:
Ronaye.wagner@ccnw.net
Investigator:
Last name:
Kristine Rinn, MD
Email:
Principal Investigator
Facility:
Name:
Sheboygan Cancer & Blood Specialists
Address:
City:
Sheboygan
Zip:
53081
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maria Splittgerber
Phone:
920-452-1650
Phone ext:
318
Email:
msplittgerber@physhealthnet.com
Investigator:
Last name:
S. Mark Bettag, MD
Email:
Principal Investigator
Start date:
December 5, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
BriaCell Therapeutics Corporation
Agency class:
Industry
Source:
BriaCell Therapeutics Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06072612
https://briacell.com/
https://www.prevailinfoworks.com/
