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8 Diseases |  |
4 Trials |
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4 Trials |  |
45 News |  |
- | Imfinzi (durvalumab) / AstraZeneca, PVX-410 / OncoPep
Trial completion date, Trial primary completion date, Combination therapy: Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov) - Dec 31, 2023
P1, N=22, Active, not recruiting, Sponsor: Massachusetts General Hospital
- | Keytruda (pembrolizumab) / Merck (MSD), PVX-410 / OncoPep
Phase classification, Trial completion date, Trial primary completion date, Combination therapy, Metastases: PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - Nov 15, 2023
P1, N=20, Active, not recruiting, Sponsor: Massachusetts General Hospital
Phase classification: P1b --> P1 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Jun 2024
- Imfinzi (durvalumab) / AstraZeneca, PVX-410 / OncoPep
Phase classification, Combination therapy: Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov) - Nov 14, 2023
P1, N=22, Active, not recruiting, Sponsor: Massachusetts General Hospital
Phase classification: P1b --> P1 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Jun 2024 Phase classification: P1b --> P1
- citarinostat (ACY-241) / BMS, PVX-410 / OncoPep
Immune Profiling and Responses of Smoldering Multiple Myeloma Patients Treated in a Phase Ib Study of Pvx-410 Vaccine Targeting XBP1/CD138/CS1 Antigens, and Citarinostat, a Histone Deacetyla... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2448;
PB and marrow transcriptome profiling along with the immunogenicity studies are in progress and will be presented. We will evaluate whether PB mononuclear cells have the potential to replace BM as a surrogate for genetic and immunological surveillance in SMM, as we anticipate that further understanding of the immune alterations among patients with SMM and the response to immunomodulatory therapy may provide insight on early intervention and prevention of progression to symptomatic disease.
- || citarinostat (ACY-241) / BMS, PVX-410 / OncoPep
Enrollment closed, Trial completion date, Trial primary completion date, Epigenetic controller: A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (clinicaltrials.gov) - Jan 31, 2023
P1b, N=19, Active, not recruiting, Sponsor: Massachusetts General Hospital
We will evaluate whether PB mononuclear cells have the potential to replace BM as a surrogate for genetic and immunological surveillance in SMM, as we anticipate that further understanding of the immune alterations among patients with SMM and the response to immunomodulatory therapy may provide insight on early intervention and prevention of progression to symptomatic disease. Recruiting --> Active, not recruiting | Trial completion date: May 2022 --> Jun 2023 | Trial primary completion date: May 2022 --> Jun 2023
- | Keytruda (pembrolizumab) / Merck (MSD), PVX-410 / OncoPep
Trial primary completion date, Combination therapy, Metastases: PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - Dec 22, 2022
P1b, N=20, Active, not recruiting, Sponsor: Massachusetts General Hospital
Recruiting --> Active, not recruiting | Trial completion date: May 2022 --> Jun 2023 | Trial primary completion date: May 2022 --> Jun 2023 Trial primary completion date: Dec 2022 --> Jun 2023
- | Imfinzi (durvalumab) / AstraZeneca, PVX-410 / OncoPep
Trial completion date, Trial primary completion date, Combination therapy: Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov) - Dec 22, 2022
P1b, N=22, Active, not recruiting, Sponsor: Massachusetts General Hospital
Trial primary completion date: Dec 2022 --> Jun 2023 Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Dec 2021 --> Jun 2023
- Keytruda (pembrolizumab) / Merck (MSD), PVX-410 / OncoPep
A phase 1b study of PVX-410 vaccine in combination with pembrolizumab in metastatic triple negative breast cancer (mTNBC) (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_833;
P2
Both pembrolizumab and atezolizumab are FDA approved for programmed cell death ligand 1 positive (PDL1+) mTNBC...Pts received 6 doses of 800µg PVX emulsified in Montanide ISA 720 VG by subcutaneous injection co-administered with intramuscular Hiltonol weekly for 6 weeks (wks) followed by booster vaccine doses at wks 10 and 28, with concurrent intravenous 200 mg PEM every 3 wks starting with the second PVX dose...Clinical disease control was observed with a CBR of 31.6%. Based on these promising immune response results in this pretreated population, a phase 2 study with PVX+PEM in combination with standard chemotherapy in treatment naïve, PD-L1+ mTNBC is underway (NCT04634747).
- || PVX-410 / OncoPep
Trial initiation date, Metastases: Phase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer (clinicaltrials.gov) - Sep 9, 2021
P2, N=53, Not yet recruiting, Sponsor: OncoPep, Inc.
Based on these promising immune response results in this pretreated population, a phase 2 study with PVX+PEM in combination with standard chemotherapy in treatment naïve, PD-L1+ mTNBC is underway (NCT04634747). Initiation date: Apr 2021 --> Nov 2021
- | Imfinzi (durvalumab) / AstraZeneca, PVX-410 / OncoPep
Trial completion date, Trial primary completion date, Combination therapy: Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov) - May 10, 2021
P1b, N=22, Active, not recruiting, Sponsor: Massachusetts General Hospital
Initiation date: Apr 2021 --> Nov 2021 Trial completion date: Feb 2022 --> Sep 2022 | Trial primary completion date: Feb 2021 --> Dec 2021
- || Keytruda (pembrolizumab) / Merck (MSD), PVX-410 / OncoPep
Enrollment closed, Trial primary completion date, Combination therapy, Metastases: PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - May 10, 2021
P1b, N=20, Active, not recruiting, Sponsor: Massachusetts General Hospital
Trial completion date: Feb 2022 --> Sep 2022 | Trial primary completion date: Feb 2021 --> Dec 2021 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Dec 2022
- | citarinostat (ACY-241) / BMS, PVX-410 / OncoPep
Trial completion date, Trial primary completion date, Epigenetic controller: A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (clinicaltrials.gov) - Feb 24, 2021
P1b, N=20, Recruiting, Sponsor: Massachusetts General Hospital
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Dec 2022 Trial completion date: May 2021 --> May 2022 | Trial primary completion date: May 2021 --> May 2022
- |||| PVX-410 / OncoPep
New P2 trial, Metastases: Phase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer (clinicaltrials.gov) - Nov 17, 2020
P2, N=53, Not yet recruiting, Sponsor: OncoPep, Inc.
- | Revlimid (lenalidomide) / BMS, PVX-410 / OncoPep
Clinical, Journal: Assessment of Safety and Immunogenicity of PVX-410 Vaccine With or Without Lenalidomide in Patients With Smoldering Multiple Myeloma: A Nonrandomized Clinical Trial. (Pubmed Central) - Oct 24, 2019
P1/2
Overall, these results suggest that the vaccine is safe and immunogenic in this patient population and support continued study of PVX-410 in SMM. ClinicalTrials.gov identifier: NCT01718899.
- Imfinzi (durvalumab) / AstraZeneca, BMS, PVX-410 / OncoPep
A phase 1b study of PVX-410 (PVX) vaccine plus durvalumab (DUR) as adjuvant therapy in HLA-A2+ early stage triple negative breast cancer (eTNBC) to assess safety and immune response (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_733;
Immune response data demonstrate that PVX induces antigen-specific T cell expansion and activation in these pts as observed by increases in PVX tetramer, IFN?, TNF?, IL-2 and CD137 positive T cells. These immune responses to PVX persisted for up to 6 months in most patients, indicating a prolonged immune response.
- | Keytruda (pembrolizumab) / Merck (MSD), PVX-410 / OncoPep
Trial primary completion date, Combination therapy, Metastases: PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - Aug 26, 2019
P1b, N=20, Recruiting, Sponsor: Massachusetts General Hospital
These immune responses to PVX persisted for up to 6 months in most patients, indicating a prolonged immune response. Trial primary completion date: Dec 2020 --> Dec 2021
- | Imfinzi (durvalumab) / AstraZeneca, PVX-410 / OncoPep
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov) - Aug 26, 2019
P1b, N=22, Active, not recruiting, Sponsor: Massachusetts General Hospital
Trial primary completion date: Dec 2020 --> Dec 2021 Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Feb 2022 | Trial primary completion date: Dec 2019 --> Feb 2021
- ||||| PVX-410 / OncoPep
Clinical: Monthly theme | In August 2018, @AjayNookaMD and colleagues published the results of the PVX-410 vaccine alone, or with len, for patients with smoldering MM in @JAMAOnc. The PVX-410 vaccine was safe and increased immunogenicity in patients with SMM. https://t.co/LYVn30D5f0 #mmsm (Twitter) - Jul 28, 2019
- |||| Zeltherva (galinpepimut-S) / SELLAS Life Sciences, PVX-410 / OncoPep
Clinical: @AjayNookaMD Professor i am wondering, Can Pvx-410 or galinpepimut-S kind of vaccines be effective in well treated (CR/sCR) myeloma patients? (Twitter) - Mar 25, 2019
- ||| Zeltherva (galinpepimut-S) / SELLAS Life Sciences, PVX-410 / OncoPep
Clinical: @NoopurRajeMD Professor i am wondering, Can Pvx-410 or galinpepimut-S kind of vaccines be effective in well treated (CR/sCR) myeloma patients? (Twitter) - Mar 25, 2019
- | Imfinzi (durvalumab) / AstraZeneca, PVX-410 / OncoPep
Trial completion date, Trial primary completion date, Combination therapy: Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov) - Dec 26, 2018
P1b, N=20, Recruiting, Sponsor: Massachusetts General Hospital
Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Feb 2022 | Trial primary completion date: Dec 2019 --> Feb 2021 Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Aug 2019 --> Dec 2019
- | citarinostat (ACY-241) / BMS, PVX-410 / OncoPep
Enrollment open, Epigenetic controller: A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (clinicaltrials.gov) - Oct 24, 2018
P1b, N=20, Recruiting, Sponsor: Massachusetts General Hospital
Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Aug 2019 --> Dec 2019 Active, not recruiting --> Recruiting
- | citarinostat (ACY-241) / BMS, PVX-410 / OncoPep
Trial completion date, Trial primary completion date, Epigenetic controller: A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (clinicaltrials.gov) - Jul 16, 2018
P1b, N=20, Active, not recruiting, Sponsor: Massachusetts General Hospital
Active, not recruiting --> Recruiting Trial completion date: Sep 2021 --> May 2021 | Trial primary completion date: Sep 2019 --> May 2021
- Keytruda (pembrolizumab) / Merck (MSD), PVX-410 / OncoPep
Enrollment open, Combination therapy, Metastases: PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - Jan 29, 2018
P1b, N=20, Recruiting, Sponsor: Massachusetts General Hospital
Trial completion date: Sep 2021 --> May 2021 | Trial primary completion date: Sep 2019 --> May 2021 Not yet recruiting --> Recruiting
- | Keytruda (pembrolizumab) / Merck (MSD), PVX-410 / OncoPep
New P1 trial, Combination therapy, Metastases: PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - Dec 5, 2017
P1b, N=20, Not yet recruiting, Sponsor: Massachusetts General Hospital
- citarinostat (ACY-241) / BMS, PVX-410 / OncoPep
Enrollment closed, Epigenetic controller: A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (clinicaltrials.gov) - Oct 31, 2017
P1b, N=26, Active, not recruiting, Sponsor: Massachusetts General Hospital
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- citarinostat (ACY-241) / BMS, PVX-410 / OncoPep
Enrollment open, Epigenetic controller: A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (clinicaltrials.gov) - Jan 19, 2017
P1b, N=26, Recruiting, Sponsor: Massachusetts General Hospital
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- Imfinzi (durvalumab) / AstraZeneca, PVX-410 / OncoPep
Enrollment open, Combination therapy: Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov) - Oct 25, 2016
P1b, N=20, Recruiting, Sponsor: Massachusetts General Hospital
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | PVX-410 / OncoPep
Trial completion: Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma (clinicaltrials.gov) - Sep 28, 2016
P1/2, N=22, Completed, Sponsor: OncoPep, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | citarinostat (ACY-241) / BMS, PVX-410 / OncoPep
New P1 trial, Epigenetic controller: A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (clinicaltrials.gov) - Sep 1, 2016
P1b, N=26, Not yet recruiting, Sponsor: Massachusetts General Hospital
- | Imfinzi (durvalumab) / AstraZeneca, PVX-410 / OncoPep
New P1 trial, Combination therapy: Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov) - Jul 11, 2016
P1b, N=20, Not yet recruiting, Sponsor: Massachusetts General Hospital
- | PVX-410 / OncoPep
Enrollment closed, Trial primary completion date: Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma (clinicaltrials.gov) - May 4, 2015
P1/2, N=22, Active, not recruiting, Sponsor: OncoPep, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2015 --> Apr 2016
- PVX-410 / OncoPep
Trial primary completion date: Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma (clinicaltrials.gov) - May 29, 2014
P1/2, N=22, Recruiting, Sponsor: OncoPep, Inc.
Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2015 --> Apr 2016 Trial primary completion date: Sep 2014 --> Mar 2015
- | PVX-410 / OncoPep
Enrollment change: Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma (clinicaltrials.gov) - May 29, 2014
P1/2, N=22, Recruiting, Sponsor: OncoPep, Inc.
Trial primary completion date: Sep 2014 --> Mar 2015 N=13 --> 22
- | PVX-410 / OncoPep
Enrollment open: Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma (clinicaltrials.gov) - Jul 1, 2013
P1/2, N=13, Recruiting, Sponsor: OncoPep, Inc.
N=13 --> 22 Active, not recruiting --> Recruiting
- | PVX-410 / OncoPep
New P1/2 trial: Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma (clinicaltrials.gov) - Oct 29, 2012
P1/2, N=13, Recruiting, Sponsor: OncoPep, Inc.