Therapy Detail
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| Therapy Name | Nivolumab + NKTR-214 |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| NKTR-214 | Bempegaldesleukin|Bempeg | Bempegaldesleukin (NKTR-214) comprises IL2 bound to polyethylene glycol, which stimulates anti-tumor immune response, potentially resulting in decreased tumor growth (PMID: 26832745, PMID: 32723187). | ||
| Nivolumab | Opdivo | MDX-1106|BMS-936558 | Immune Checkpoint Inhibitor 98 PD-L1/PD-1 antibody 67 | Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer, small cell lung cancer, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, and esophageal squamous cell carcinoma, as a monotherapy or in combination with Yervoy (ipilimumab) in patients with melanoma, renal cell carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy in patients with PD-L1-positive (>=1%) metastatic non-small cell lung cancer without EGFR or ALK alterations, in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent non-small cell lung cancer without EGFR or ALK alterations, and in combination with Cabometyx (cabozantinib) in patients with advanced renal cell carcinoma (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| Unknown unknown | melanoma | not applicable | Nivolumab + NKTR-214 | Phase Ib/II | Actionable | In a Phase I/II trial, NKTR-214 and Opdivo (nivolumab) combination treatment demonstrated safety and preliminary efficacy, resulted in radiographic response in one and complete response in another patient with melanoma (Journal of Clinical Oncology 35, no. 15_suppl; NCT02983045). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02983045 | Phase Ib/II | Nivolumab + NKTR-214 | A Dose Escalation and Cohort Expansion Study of CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-1 Antibody (Nivolumab) in Patients With Select Advanced or Metastatic Solid Tumors (PIVOT-02) | Active, not recruiting | USA | CAN | 6 |
| NCT03282344 | Phase II | Nivolumab + NKTR-214 | A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma | Active, not recruiting | USA | 0 |
| NCT03835533 | Phase I | CDX-301 + INO-5151 + Nivolumab CDX-301 + Nivolumab + Poly ICLC Nivolumab + NKTR-214 | Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (PORTER) | Recruiting | USA | 0 |
| NCT04410445 | Phase III | Nivolumab Nivolumab + NKTR-214 | Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12) | Recruiting | USA | 14 |
| NCT04730349 | Phase Ib/II | Nivolumab + NKTR-214 | A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer (PIVOT IO 020) | Not yet recruiting | USA | 4 |
| NCT03729245 | Phase III | Cabozantinib + Sunitinib Nivolumab + NKTR-214 | A Study of NKTR-214 in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC) | Active, not recruiting | USA | 10 |
| NCT04209114 | Phase III | Nivolumab + NKTR-214 Nivolumab | A Study of Nivolumab Plus NKTR-214 vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That Has Invaded the Muscle Wall of the Bladder and Who Cannot Get Cisplatin, a Type of Medicine Given to Treat Bladder Cancer. | Recruiting | USA | CAN | 18 |
| NCT03635983 | Phase III | Nivolumab Nivolumab + NKTR-214 | A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma | Recruiting | USA | CAN | 25 |
| NCT03785925 | Phase II | Nivolumab + NKTR-214 | A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer (PIVOT-10) | Active, not recruiting | USA | CAN | 19 |
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