Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ipilimumab · 1 trial · 2 indications
PFS is defined as the duration of time from the start date of study treatment to the date of earliest progression or death, whichever occurs first. Patients who neither progress nor die by the data cutoff date will be censored at the last follow up date.
DLTs are defined in the protocol.
| Arm | Type | Description |
|---|---|---|
| Phase Ib Dose Level 1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) | EXPERIMENTAL | Consenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks). |
| Phase Ib Dose Level -1: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) | EXPERIMENTAL | Consenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks). |
| Phase II: Ipilimumab plus Nivolumab and Nogapendekin alfa inbakicept (N-803) | EXPERIMENTAL | Consenting and eligible patients will receive nivolumab intravenously (IV) on Days 1 and 22, ipilimumab IV on Day 1, and the assigned dose of nogapendekin alfa inbakicept subcutaneously (SC) on Days 1 and 22 of each cycle for Cycles 1 through 4; ipilimumab will be discontinued after Cycle 4 and patients will continue to receive nivolumab and nogapendekin alfa inbakicept on the same schedule for up to 2 years. Cycles are 42 days (6 weeks). |
| Name | Type | Description |
|---|---|---|
| Ipilimumab | DRUG | Ipilimumab will be given intravenously at a dose of 1mg/kg. |
| Nivolumab | DRUG | Nivolumab will be given intravenously at a dose of 360mg. |
| Nogapendekin alfa inbakicept | DRUG | Nogapendekin alfa inbakicept will be given subcutaneously at the assigned dose level. |
Inclusion Criteria: * Histologically or cytologically confirmed, previously untreated or recurrent metastatic NSCLC. * Availability of archival biopsy tissue or willingness to undergo a biopsy prior to C1D1 for biomarker analysis, including PD-L1 by IHC using a CLIA-certified test. Results of the P...
Ipilimumab is being studied as a first-line treatment for patients with Stage IV or recurrent non-small cell lung cancer. It is given in combination with nivolumab and nogapendekin alfa inbakicept (N-803) in an ongoing Phase 1 clinical trial.
Ipilimumab is a monoclonal antibody (mab) that targets CTLA-4, a protein on T cells that acts as a checkpoint to dampen immune responses. By blocking CTLA-4, ipilimumab is designed to enhance the immune system's ability to attack cancer cells.
Ipilimumab is being developed by ImmunityBio, Inc. (ticker: IBRX). The company is conducting a Phase 1 clinical trial of ipilimumab in combination with other agents for non-small cell lung cancer.
Ipilimumab is in Phase 1 clinical development for non-small cell lung cancer. It is an investigational drug and has not been approved by the FDA for this indication. The ongoing trial is currently recruiting participants.
Ipilimumab is being evaluated in a single Phase 1 trial with the identifier NCT07355205. This trial is testing first-line ipilimumab plus nivolumab and nogapendekin alfa inbakicept (N-803) in patients with Stage IV or recurrent non-small cell lung cancer. The study is recruiting 26 participants in the United States.
Ipilimumab is the generic name for the drug also known as Yervoy. In the context of this development program, ImmunityBio is studying ipilimumab as part of a combination regimen for non-small cell lung cancer.