The purpose of this study is to evaluate if the treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and useful for patients with certain types of cancer. The study also will investigate if NEO-PV-01 + adjuvant with nivolumab may represent a substantial improvement over other available therapies such as nivolumab alone. All eligible patients will receive NEO-PV-01 + adjuvant and nivolumab while on this trial.
This clinical trial will enroll patients with metastatic or advanced melanoma, lung, or bladder cancer. The three agents being used in this study are: * A new, investigational, personal cancer vaccine called "NEO-PV-01" * Poly-ICLC (Hiltonol), an investigational adjuvant that is used to help stimulate the immune system * A cancer drug called nivolumab (OPDIVO®) These agents are considered immunotherapy and work by stimulating the immune system to fight cancer. NEO-PV-01 is a truly personal vaccine therapy in that it is custom designed and manufactured to include targets for the immune system that are present uniquely on an individual's cancer. Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01 more effective. Nivolumab helps T-cells, a certain type of immune cell, that recognize these targets to reach and attack the tumor. Nivolumab is in clinical development for treatment of bladder cancer and is approved by the FDA (the U.S. Food and Drug Administration) for the treatment of some lung, skin, kidney, and blood cancers. The purpose of this study is to find out if treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and effective for patients with melanoma, lung, or bladder cancer. The study also will see if NEO-PV-01 vaccine + adjuvant with nivolumab can improve responses compared to available therapies such as nivolumab monotherapy The side effects of NEO-PV-01 + adjuvant and nivolumab will be monitored and additional research tests will be done to assess the immune response against each individual's cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
City of Hope
Duarte, California, United States
UCLA Medical Center
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Center
Boston, Massachusetts, United States
Washington University in St. Louis
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Rate of adverse events including SAEs and AEs leading to treatment discontinuation
Rate of adverse events including SAEs and AEs leading to treatment discontinuation
Time frame: Baseline through 100 days after last dose of nivolumab
Rate of adverse events including SAEs and AEs leading to changes in safety laboratory evaluations
Rate of adverse events including SAEs and AEs leading to changes in safety laboratory evaluations
Time frame: Baseline through 100 days after last dose of nivolumab
Rate of adverse events including SAEs and AEs leading to physical examination findings
Rate of adverse events including SAEs and AEs leading to physical examination findings
Time frame: Baseline through 100 days after last dose of nivolumab
Rate of adverse events including SAEs and AEs leading to vital signs findings
Rate of adverse events including SAEs and AEs leading to vital signs findings
Time frame: Baseline through 100 days after last dose of nivolumab
Rate of adverse events including SAEs and AEs leading to changes in ECOG status
Rate of adverse events including SAEs and AEs leading to changes in ECOG status
Time frame: Baseline through 100 days after last dose of nivolumab
Objective response rate (ORR)
Objective response rate (ORR), defined as the proportion of patients who achieve complete response (CR) or partial response (PR) based on Response Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Baseline through 104 weeks
Duration of response (DOR)
Duration of response (DOR), defined as the date of the first documentation of a confirmed response to the date of the first documented PD.
Time frame: Baseline through 104 weeks
Clinical benefit rate (CBR)
Clinical benefit rate (CBR), defined as the proportion of patients who achieve CR, PR, or stable disease (SD) based on RECIST v1.1
Time frame: Baseline through 104 weeks
Response conversion rate (RCR)
Response conversion rate (RCR) of NEO-PV-01 + adjuvant with nivolumab at Week 24 defined as the proportion of patients who improve in RECIST v1.1 category from Week 12 to Week 24 (e.g., PD to SD/PR/CR, SD to PR/CR, PR to CR).
Time frame: Baseline through 104 weeks
Progression-free survival (PFS)
Progression-free survival (PFS), defined as the time from the date of first dosing to the date of first documented PD or death.
Time frame: Baseline through 104 weeks
Overall survival (OS)
Overall survival (OS), defined from the date of enrollment and death from any cause.
Time frame: Baseline through 104 weeks
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