Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nivolumab · 1 trial · 2 indications
Establish MTD of plinabulin in combination with nivolumab and ipilimumab for patients with recurrent SCLC. MTD reflects the highest dose of plinabulin that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. DLTs were defined in accordance to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease(PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Progression Free Survival (PFS) is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause.
| Arm | Type | Description |
|---|---|---|
| Phase I (Dose Escalation): nivolumab, ipilimumab and plinabulin | EXPERIMENTAL | On Day 1 in a 21-day cycle, all patients will receive nivolumab (1 mg/kg, IV), ipilimumab (3 mg/kg, IV) and plinabulin (escalating cohorts, IV). After 4 treatment cycles, ipilimumab will be discontinued and patients will continue treatment with nivolumab 240 mg and plinabulin every 2 weeks (maintenance period) until one of the end of treatment criteria occur. Plinabulin escalation is as follows: Level -1 : 13.5mg/m\^2 Level 1 (start) : 20mg/m\^2 Level 2 : 30mg/m\^2 |
| Phase II: nivolumab, ipilimumab, and plinabulin | EXPERIMENTAL | On Day 1 in a 21-day cycle, all patients will receive nivolumab (1 mg/kg, IV), ipilimumab (3 mg/kg, IV) and plinabulin (MTD from Phase I). After 4 treatment cycles, ipilimumab will be discontinued and patients will continue treatment with nivolumab 240 mg and plinabulin every 2 weeks (maintenance period) until one of the end of treatment criteria occur . |
| Name | Type | Description |
|---|---|---|
| Nivolumab | DRUG | A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1,PCD-1,) with immune checkpoint inhibitory and antineoplastic activities. |
| Plinabulin | DRUG | Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity originally developed by Nereus Pharmaceuticals, Inc., and now by BeyondSpring Pharmaceuticals, Inc. It belongs to the diketopiperazine class of compounds with a chemical name 2, 5-piperazinedione, 3-\[\[5-(1,1-dimethylethyl)-1H-imidazol-4-yl\[methylene\]-6-(phenylmethylene)-, (3Z,6Z) (trivial name t-butyl-dehydrophenylahistin). |
| Ipilimumab | DRUG | Ipilimumab is a monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. |
Inclusion Criteria: The patients must satisfy all of the following inclusion/exclusion criteria in order to be eligible for the study: * Must have signed and dated written informed consent form in accordance with regulatory and institutional guidelines. * Males and females aged \>18 years at time ...
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Nivolumab is used for Non-small Cell Lung Cancer Metastatic and Lung Cancer. It is being studied in combination with other agents. In a completed Phase 1 trial, Nivolumab was combined with Plinabulin in patients with metastatic Non-small Cell Lung Cancer. The trial enrolled 18 participants in the United States.
Nivolumab is developed by BeyondSpring, Inc., a company traded under the ticker BYSI. The drug is being investigated in oncology, specifically for Non-small Cell Lung Cancer Metastatic and Lung Cancer. BeyondSpring is conducting clinical trials to evaluate Nivolumab in combination with other therapies.
Nivolumab is in Phase 1 clinical development. It is an investigational drug, not yet approved. Two Phase 1 trials have been completed, one in metastatic Non-small Cell Lung Cancer and another in recurrent Small Cell Lung Cancer. Both trials were conducted in the United States.
Nivolumab has been studied in two completed Phase 1 trials. NCT02812667 evaluated Nivolumab with Plinabulin in metastatic Non-small Cell Lung Cancer, enrolling 18 patients. NCT03575793 studied Nivolumab, Ipilimumab, and Plinabulin in recurrent Small Cell Lung Cancer, enrolling 39 patients. Both trials were in the United States.
No, Nivolumab is not the same as Plinabulin. Nivolumab is the drug being developed by BeyondSpring, Inc. Plinabulin is a separate agent used in combination with Nivolumab in clinical trials. The trials combine Nivolumab with Plinabulin, sometimes with Ipilimumab, to treat lung cancers.