Breast Cancer Vaccine in Combination With Pembrolizumab for Treatment of Persistent, Recurrent, or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04418219|
Recruitment Status : Withdrawn (Funding Discontinued)
First Posted : June 5, 2020
Last Update Posted : June 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Breast Carcinoma Prognostic Stage IV Breast Cancer AJCC v8 Recurrent Breast Carcinoma Refractory Breast Carcinoma||Drug: Cyclophosphamide Biological: Allogeneic GM-CSF-secreting Breast Cancer Vaccine SV-BR-1-GM Biological: Pembrolizumab Biological: Recombinant Interferon Alpha 2b-like Protein Other: Questionnaire Administration Other: Quality of Life Assessment||Phase 1 Phase 2|
I. To evaluate the safety of the allogeneic GM-CSF-secreting breast cancer vaccine SV-BR-1-GM (SV-BR-1-GM) regimen when administered in combination with pembrolizumab in patients with human leukocyte antigen (HLA) match. (Phase I) II. To evaluate the overall response rate of the SV-BR1-GM regimen in combination with pembrolizumab. (Phase II)
I. To evaluate the non-progressive rate of the SV-BR-1-GM regimen in combination with pembrolizumab.
II. To evaluate the duration of response of the SV-BR-1-GM regimen in combination with pembrolizumab.
III. To evaluate immune responses elicited by the SV-BR-1-GM regimen when administered in combination with pembrolizumab.
IV. To evaluate patient and tumor characteristics that may be predictive of responses to the SV-BR-1-GM regimen when administered in combination with pembrolizumab.
V. To evaluate quality of life (QOL) in patients administered the SV-BR-1-GM regimen in combination with pembrolizumab by the Edmonton Symptom Assessment Survey.
Patients receive cyclophosphamide intravenously (IV) over 1-2 hours on day 1, SV-BR-1-GM intradermally (ID) on day 3, pembrolizumab IV over 30 minutes on day 5, and interferon-alpha-2b ID on days 5 and 7. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2-4 weeks and then every 3 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of the SV-BR-1-GM Regimen in HLA Matched Metastatic Breast Cancer Patients in Combination With Pembrolizumab|
|Estimated Study Start Date :||December 21, 2020|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2024|
Experimental: Treatment (SV-BR-1GM, pembrolizumab)
Patients receive cyclophosphamide IV over 1-2 hours on day 1, SV-BR-1-GM ID on day 3, pembrolizumab IV over 30 minutes on day 5, and interferon-alpha-2b ID on days 5 and 7. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
alkylating agent used in the treatment of several forms of cancer including leukemias, lymphomas and breast cancer.
Biological: Allogeneic GM-CSF-secreting Breast Cancer Vaccine SV-BR-1-GM
Breast Cancer Vaccine SV-BR-1-GM, Bria-IMT, GM-CSF Gene-transfected Breast Cancer Vaccine SV-BR-1-GM, SV-BR-1 Breast Cancer Cell Line Vaccine, SV-BR-1-GM, SV-BR-1-GM Vaccine
1374853-91-4, Immunoglobulin G4, Anti-(Human Programmed Cell Death 1); Humanized Mouse Monoclonal (228-L-proline(H10-S>P))gamma 4 Heavy Chain (134-218'')-disulfide with Humanized Mouse Monoclonal Kappa Light Chain Dimer (226-226'''':229-229'''')-bisdisulfide, Keytruda, Lambrolizumab, MK-3475, PEMBROLIZUMAB, SCH 900475
Biological: Recombinant Interferon Alpha 2b-like Protein
Novaferon, Recombinant IFN Alfa-2b-like Protein
Other: Questionnaire Administration
Other: Quality of Life Assessment
- Incidence of adverse events [ Time Frame: up to 1 year ]Toxicity will be determined using the Common Terminology Criteria for Adverse Events (CTCAE v 5.0).
- Objective response rate (ORR) [ Time Frame: up to 1 year ]Will be defined as complete response (CR), partial response (PR) or stable disease (SD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-modified (i)RECIST. The method of Atkinson and Brown will be used to allow for the two-stage design.
- Non-progressive rate [ Time Frame: Up to one year ]Defined as time to progression of disease, measured by CR, PR or SD per RECIST 1.1 and iRECIST. This will be estimated using the Kaplan-Meier method.
- Durability of response [ Time Frame: Up to one year ]Defined in time as time to progressive disease.
- Delayed type hypersensitivity (DTH) skin tests [ Time Frame: Up to 1 year ]Will be evaluated comparing pre-dose with post-dose samples using simple statistical testing (e.g. Student's t-Test).
- T cell responses to SV-BR-1 [ Time Frame: Up to 1 year ]Will be evaluated comparing pre-dose with post-dose samples using simple statistical testing (e.g. Student's t-Test).
- Tumor expression of PD-L1 [ Time Frame: Up to 1 year ]
- Tumor expression of PD-L2 [ Time Frame: Up to 1 year ]
- Tumor expression of cancer/testis antigens such as PRAME [ Time Frame: Up to 1 year ]
- Type of breast cancer (estrogen receptor [ER] positive, HER2 positive, triple negative) [ Time Frame: Up to 1 year ]
- Edmonton Symptom Assessment Survey [ Time Frame: Up to 1 year ]Assessment of nine symptoms commonly seen in cancer patients. Patients rate on scale of 0-10 with 0 meaning the symptom is absent and 10 meaning the worst possible severity.
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): NCT04418219
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|