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Also known as Personal cancer vaccine
NEO-PV-01 · 2 trials · 9 indications
Rate of adverse events and severe adverse events leading to treatment discontinuation and those adverse events and severe adverse events detected during symptom-directed physical examinations (changes in safety laboratory evaluations, physical examination findings. vital signs, and ECOG PS)
| Arm | Type | Description |
|---|---|---|
| NEO-PV-01/Adjuvant + pembrolizumab + chemotherapy | EXPERIMENTAL | Pembrolizumab at a dose of 200 mg administered by intravenous infusion (IV) plus chemotherapy with carboplatin (AUC 5) + pemetrexed (500 mg/m2) every 3 weeks for 4 cycles. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously (one vial of pooled peptides per injection site) in up to four distinct sites (each extremity or flanks) while continuing therapy with pembrolizumab. |
| Drug: NEO-PV-01 + Nivolumab + Adjuvant | EXPERIMENTAL | Nivolumab at a dose of 240 mg administered by intravenous (IV) infusion over 30 minutes every two weeks. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously (one vial of pooled peptides per injection site) in up to four distinct sites (each extremity or flanks) while continuing therapy with nivolumab. |
| Name | Type | Description |
|---|---|---|
| NEO-PV-01 | BIOLOGICAL | Personal Cancer Vaccine |
| Pembrolizumab | BIOLOGICAL | monoclonal antibody against PDL1 |
| Adjuvant | OTHER | immune adjuvant |
| Carboplatin | DRUG | chemotherapy |
| Pemetrexed | DRUG | chemotherapy |
| Nivolumab | BIOLOGICAL | monoclonal antibody against PD1 |
Inclusion Criteria: * Willing and able to give written informed consent. * Have histologically confirmed unresectable or metastatic nonsquamous NSCLC and having received no prior systemic therapy for metastatic disease. * Have at least 1 site of disease measurable by RECIST v1.1 that has not been t...
NEO-PV-01 is an investigational personalized cancer vaccine being studied for the treatment of urinary bladder cancer, transitional cell carcinoma of the bladder, malignant melanoma, and non-small-cell lung cancer. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
NEO-PV-01 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational cancer vaccine.
NEO-PV-01 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one involving patients with melanoma, lung cancer, or bladder cancer, and another involving patients with non-small-cell lung cancer. The drug remains investigational and has not received FDA approval.
NEO-PV-01 has been studied in two completed Phase 1 clinical trials. The first, NCT02897765, tested the vaccine with nivolumab in patients with melanoma, lung cancer, or bladder cancer. The second, NCT03380871, tested the vaccine with pembrolizumab and chemotherapy in patients with non-small-cell lung cancer.
NEO-PV-01 is a personalized cancer vaccine designed to target neoantigens, which are unique mutations present on a patient's tumor cells. By stimulating the immune system to recognize and attack these specific neoantigens, the vaccine aims to generate an antitumor response. It is being studied in combination with checkpoint inhibitors.
Yes, NEO-PV-01 is a personalized cancer vaccine. It is individually manufactured for each patient based on the specific genetic mutations found in their tumor. This approach is intended to tailor the immune response to the unique characteristics of each patient's cancer.