Arm 2: Intratumoral Injection of Dengue Virus-1 #45AZ5 (PV-001-DV) in Patients With Advanced Melanoma
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|ClinicalTrials.gov Identifier: NCT03989895|
Recruitment Status : Not yet recruiting
First Posted : June 18, 2019
Last Update Posted : September 12, 2019
The purpose of this arm of the study is to find the best way to give patients this investigational product and determine if it can treat advanced melanoma by stimulating the immune system. PV-001-DV is an attenuated (weakened) strain of dengue virus developed as a potential preventative vaccine for dengue fever by the US Army as Dengue Virus-1 #45AZ5. This is the first time PV-001-DV will be given to patients with melanoma. Up to 4 dose levels of PV-001-DV will tested in this arm. PV-001-DV (at the lowest dose) will be given to a group of 3 people. As each dose level is found to be safe, it will be given to another other 3 people at the next higher dose level, for a total of up to 10 people in this study. Investigators will monitor patients carefully for any harmful side effects. The side effects in people cannot be completely known ahead of time.
Patients must be progressing after having completed prior therapy with a PD-1 / PD-L1 antagonist alone or in combination with anti-CTLA-4. If the patient is positive for BRAF, the patient must have progressed on at least one BRAF inhibitor in addition to a PD-1 / PD-L1 inhibitor alone or in combination with CTLA-4 for metastatic melanoma.
Patients will have a prescribed amount of PV-001-DV injected into one of their melanoma tumors. Scans will be performed during the study at different times to see if their tumors have changed in size. Patients will also have their blood and small samples of tumors tested for changes to the immune system. After 365 days, the trial will be completed for that patient.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Melanoma||Biological: Dengue Virus-1 #45AZ5 (PV-001-DV)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm dose-finding study|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Safety and Efficacy of PV-001-DV in Combination With Infusion of PV-001-DC in Patients With Advanced Melanoma|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||September 2022|
Experimental: Dengue Virus-1 #45AZ5 (PV-001-DV)
Intratumoral injection of PV-001-DV
Biological: Dengue Virus-1 #45AZ5 (PV-001-DV)
Intratumoral injection of PV-001-DV
- Incidence and severity of Treatment-Emergent Adverse Events of PV-001-DV [ Time Frame: 365 days ]Treatment-Emergent Adverse Event Incidence of patients receiving intratumoral injection of PV-001-DV
- Overall Response Rate (ORR) [ Time Frame: 365 days ]Tumor response will be measured per investigator's assessment according to RECIST v1.1 and iRECIST
- Progression-Free Survival (PFS) [ Time Frame: 365 days ]The length of time during the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse, up to the end of the study
- Overall Survival (OS) [ Time Frame: 365 days ]Overall Survival is measured from the date of enrollment to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date, up to the end of the study
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): NCT03989895
|Contact: Bruce W Lyday||(714) email@example.com|