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Also known as N-803 (Cohort 2 part B), N-803, N-803 and BCG, N803, N-803 (IL-15 Superagonist)
N-803+ Pembrolizumab · 1 trial · 13 indications
ORR reflects tumor shrinkage and is the key measure of antitumor activity.
OS is the gold-standard efficacy endpoint; the protocol explores whether an ALC rise predicts a survival benefit.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | OTHER | Patients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor. 1a - Non-small cell lung cancer 1b - Small cell lung cancer 1c - Urothelial carcinoma 1d - Head and neck squamous cell carcinoma 1e - Merkel cell carcinoma 1f - Melanoma 1g - Renal cell carcinoma 1h - Gastric cancer 1i - Cervical cancer 1j - Hepatocellular carcinoma 1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer |
| Cohort 2 | OTHER | Patients with NSCLC whose tumors have high PD-L1 expression (TPS ≥ 50%) and who relapsed on a PD-1 checkpoint inhibitor after experiencing an initial CR or PR when they received checkpoint inhibitor as a single-agent for first-line treatment. |
| Cohort 3 | OTHER | Patients with NSCLC who had an initial CR or PR but subsequently relapsed on maintenance PD-1 checkpoint inhibitor therapy when they initially received checkpoint inhibitor therapy in combination with chemotherapy as first-line treatment. |
| Cohort 4 | EXPERIMENTAL | Patients who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease (SD) for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy. |
| Cohort 5 | EXPERIMENTAL | Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4. |
| Cohort 6 | EXPERIMENTAL | Patients who have progressed after an initial response (CR or PR) to a PD-1/PD-L1 checkpoint inhibitor but now exhibit acquired resistance. They have received exactly one line of anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab) for advanced NSCLC (Stage IV or recurrent). |
| Name | Type | Description |
|---|---|---|
| N-803 + Pembrolizumab | DRUG | Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. |
| N-803 + Nivolumab | DRUG | Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. |
| N-803 + Atezolizumab | DRUG | Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. |
| N-803 + Avelumab | DRUG | Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. |
| N-803 + Durvalumab | DRUG | Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. |
| N-803 + Pembrolizumab + PD-L1 t-haNK | DRUG | Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly |
| N-803 + Nivolumab + PD-L1 t-haNK | DRUG | Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly |
| N-803 + Atezolizumab + PD-L1 t-haNK | DRUG | Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly |
| N-803 + Avelumab + PD-L1 t-haNK | DRUG | Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly |
| N-803 + Durvalumab + PD-L1 t-haNK | DRUG | Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly |
| N-803 + Docetaxel + Pembrolizumab | DRUG | The study employs a 6-week cycle combination of: N-803 (1.2 mg flat dose SC), docetaxel (75 mg/m² IV - first 2 cycles only), and pembrolizumab (200 mg IV). |
| N-803 + Docetaxel + Nivolumab | DRUG | The study employs a 6-week cycle combination of:N-803 (1.2 mg flat dose SC), docetaxel (75 mg/m² IV - first 2 cycles only), and nivolumab (240 mg IV). Nivolumab dosing may be increased to 480mg every four weeks as per the investigator's discretion. |
INCLUSION CRITERIA (Cohort 6 only) 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant IRB/IEC guidelines. 3. Pathologically confirmed stage IV NSCLC disease. 4. Have received exactly 1 anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab o...
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N-803 is an investigational small molecule being studied for use in several cancers, including NSCLC Stage IV, pancreatic cancer, B-cell Non-Hodgkin Lymphoma, and platinum-resistant ovarian cancer. It is also being evaluated in healthy subjects. The drug is in clinical development and has not been approved by the FDA.
N-803 targets IL-15, a cytokine involved in immune system regulation. By interacting with this target, the drug is designed to modulate immune responses, which may be relevant in cancer treatment. It is being studied in combination with other therapies for various malignancies.
N-803 is developed by ImmunityBio, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple cancer indications. ImmunityBio is publicly traded under the ticker symbol IBRX.
N-803 is in Phase 1 clinical development, though some trials are in Phase 2 and Phase 3. The drug is investigational and not yet approved. Clinical trials are ongoing or recently completed across various cancer types, including non-small cell lung cancer and pancreatic cancer.
N-803 is being studied in several trials, including NCT03228667 for multiple cancers, NCT04390399 for pancreatic cancer, NCT06745908 for NSCLC Stage IV, and NCT07049432 for B-cell Non-Hodgkin Lymphoma. These trials are at different phases and enrollment stages.
Yes, N-803 is also known as N803. It is sometimes referred to with additional descriptors, such as N-803 and BCG, N-803 plus Pembrolizumab, or N-803 (IL-15 Superagonist). These names all refer to the same investigational drug.