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DRUG:

MVI-816

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Other names: MVI-816, PAP vaccine, pTVG-HP, MVI816, MVI 816
Associations
Company:
Madison Vaccines
Drug class:
Immunostimulant, Prostatic acid phosphatase inhibitor
Related drugs:
Associations
3ms
Long-term follow up of patients treated with a DNA vaccine (pTVG-hp) for PSA-recurrent prostate cancer. (PubMed, Hum Vaccin Immunother)
The presence of T-cells specific for the PAP target antigen was detectable in 6/10 (60%) individuals with nmCSPC, and 3/5 (60%) individuals with nmCRPC, many years after immunization. The detection of immune responses to the vaccine target years after immunization suggests durable immunity can be elicited in patients using a DNA vaccine encoding a tumor-associated antigen.Trial Registration: NCT00582140 and NCT00849121.
Journal
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CSF2 (Colony stimulating factor 2) • PSAP (Prostatic Acid Phosphatase)
|
MVI-816
5ms
NCI-2018-01474: pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer (clinicaltrials.gov)
P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Nov 2024 --> Dec 2027
Trial completion date • Metastases
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Opdivo (nivolumab) • Leukine (sargramostim) • MVI-816
6ms
Enrollment closed • Metastases
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Keytruda (pembrolizumab) • MVI-118 • MVI-816
7ms
NCI-2019-07273: pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer (clinicaltrials.gov)
P2, N=60, Recruiting, University of Wisconsin, Madison | Trial completion date: Dec 2025 --> Oct 2026 | Trial primary completion date: Mar 2024 --> Jan 2025
Trial completion date • Trial primary completion date • Metastases
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Keytruda (pembrolizumab) • MVI-118 • MVI-816
11ms
Phase 2 trial of a DNA vaccine (pTVG-HP) and nivolumab in patients with castration-sensitive non-metastatic (M0) prostate cancer. (PubMed, J Immunother Cancer)
In this population, combining nivolumab with pTVG-HP vaccination was safe, and immunologically active, prolonged the time to disease progression, but did not eradicate disease. Quantitative imaging suggested that additional treatments targeting mechanisms of resistance may be required to eliminate tumors.
P2 data • Journal • Metastases
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CXCL9 (Chemokine (C-X-C motif) ligand 9) • PSAP (Prostatic Acid Phosphatase)
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • MVI-816
12ms
NCI-2018-01474: pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer (clinicaltrials.gov)
P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Nov 2023 --> Nov 2024
Trial completion date • Metastases
|
Opdivo (nivolumab) • Leukine (sargramostim) • MVI-816
12ms
Trial primary completion date
|
Keytruda (pembrolizumab) • MVI-118 • MVI-816
over1year
Vaccine Therapy and Pembrolizumab in Treating Patients With Hormone-Resistant, Metastatic Prostate Cancer (clinicaltrials.gov)
P1/2, N=66, Completed, University of Wisconsin, Madison | Active, not recruiting --> Completed
Trial completion • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
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PD-L1 expression • PD-1 expression
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Keytruda (pembrolizumab) • MVI-816
over1year
NCI-2018-01474: pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer (clinicaltrials.gov)
P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Jan 2025 --> Nov 2023 | Trial primary completion date: Jan 2024 --> Dec 2022
Trial completion date • Trial primary completion date • Metastases
|
CSF2 (Colony stimulating factor 2)
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Opdivo (nivolumab) • Leukine (sargramostim) • MVI-816
2years
NCI-2018-01474: pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer (clinicaltrials.gov)
P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Oct 2023 --> Jan 2025 | Trial primary completion date: Oct 2022 --> Jan 2024
Trial completion date • Trial primary completion date
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CSF2 (Colony stimulating factor 2)
|
Opdivo (nivolumab) • Leukine (sargramostim) • MVI-816
over2years
Phase 2 trial of T-cell activation using MVI-816 and pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC). (PubMed, J Immunother Cancer)
Findings here demonstrate that combining programmed cell death 1 blockade with MVI-816 is safe, can augment tumor-specific T cells, and can result in a favorable 6-month disease control rate. Correlative studies suggest T-cell activation by vaccination is critical to the mechanism of action of this combination. Future randomized clinical trials are needed to validate these findings.
Clinical • P2 data • Journal • PD(L)-1 Biomarker
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MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • GZMB (Granzyme B) • PSAP (Prostatic Acid Phosphatase)
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Keytruda (pembrolizumab) • MVI-816
almost3years
NCI-2018-01474: pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer (clinicaltrials.gov)
P2, N=19, Active, not recruiting, University of Wisconsin, Madison | Recruiting --> Active, not recruiting | N=41 --> 19
Enrollment closed • Enrollment change
|
CSF2 (Colony stimulating factor 2)
|
Opdivo (nivolumab) • Leukine (sargramostim) • MVI-816
3years
Vaccine Therapy and Pembrolizumab in Treating Patients With Hormone-Resistant, Metastatic Prostate Cancer (clinicaltrials.gov)
P1/2, N=66, Active, not recruiting, University of Wisconsin, Madison | Trial completion date: Sep 2021 --> Jun 2023
Clinical • Trial completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
PD-L1 expression • PD-1 expression
|
Keytruda (pembrolizumab) • MVI-816
over3years
Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer (clinicaltrials.gov)
P2, N=18, Completed, University of Wisconsin, Madison | Active, not recruiting --> Completed
Trial completion
|
CSF2 (Colony stimulating factor 2) • GZMB (Granzyme B)
|
Provenge (sipuleucel-T) • MVI-816
4years
Vaccine Therapy and Pembrolizumab in Treating Patients With Hormone-Resistant, Metastatic Prostate Cancer (clinicaltrials.gov)
P1/2, N=66, Active, not recruiting, University of Wisconsin, Madison | Recruiting --> Active, not recruiting
Clinical • Enrollment closed • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
PD-L1 expression • PD-1 expression
|
Keytruda (pembrolizumab) • MVI-816
4years
pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer (clinicaltrials.gov)
P2, N=41, Recruiting, University of Wisconsin, Madison | Trial completion date: Oct 2022 --> Oct 2023 | Trial primary completion date: Oct 2020 --> Oct 2022
Clinical • Trial completion date • Trial primary completion date
|
CSF2 (Colony stimulating factor 2)
|
Opdivo (nivolumab) • Leukine (sargramostim) • MVI-816
over4years
Vaccine Therapy and Pembrolizumab in Treating Patients With Hormone-Resistant, Metastatic Prostate Cancer (clinicaltrials.gov)
P1/2, N=72, Recruiting, University of Wisconsin, Madison | Suspended --> Recruiting
Clinical • Enrollment open • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
PD-L1 expression • PD-1 expression
|
Keytruda (pembrolizumab) • MVI-816
over4years
pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer (clinicaltrials.gov)
P2, N=41, Recruiting, University of Wisconsin, Madison | Suspended --> Recruiting
Clinical • Enrollment open
|
CSF2 (Colony stimulating factor 2)
|
Opdivo (nivolumab) • Leukine (sargramostim) • MVI-816
over4years
Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP [MVI-816]) in Patients With Progressive, Nonmetastatic, Castration-Sensitive Prostate Cancer. (PubMed, J Clin Oncol)
pTVG-HP treatment did not demonstrate an overall increase in 2-year MFS in patients with castration-sensitive prostate cancer, with the possible exception of a subgroup with rapidly progressive disease. Prespecified F-NaF PET/CT imaging conducted in a subset of patients suggests that vaccination had detectable effects on micrometastatic bone disease. Additional trials using pTVG-HP in combination with PD-1 blockade are under way.
Clinical • P2 data • Journal
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CSF2 (Colony stimulating factor 2) • KLK3 (Kallikrein-related peptidase 3)
|
CSF2 elevation
|
MVI-816
over4years
Vaccine Therapy and Pembrolizumab in Treating Patients With Hormone-Resistant, Metastatic Prostate Cancer (clinicaltrials.gov)
P1/2, N=72, Suspended, University of Wisconsin, Madison | Recruiting --> Suspended
Clinical • Trial suspension • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
PD-L1 expression • PD-1 expression
|
Keytruda (pembrolizumab) • MVI-816
over4years
pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer (clinicaltrials.gov)
P2, N=41, Suspended, University of Wisconsin, Madison | Recruiting --> Suspended
Clinical • Trial suspension
|
CSF2 (Colony stimulating factor 2)
|
Opdivo (nivolumab) • Leukine (sargramostim) • MVI-816