| IL-2 therapy . | Clinical trial . | |||||||
|---|---|---|---|---|---|---|---|---|
| Type . | Agent (company) . | Description . | Delivery route . | Indication . | Co-therapy . | Phase . | Status . | References . |
| Immunocytokine | ALKS 4230 (Alkermes) | IL-2–CD25 fusion protein | i.v. | Solid tumors | Pembrolizumab | 1/2 | Recruiting | NCT02799095 (Vaishampayan et al., 2017) |
| s.c. | Solid tumors | Pembrolizumab | 1 | Recruiting | NCT03861793 (Vaishampayan et al., 2017) | |||
| Darleukin (Philogen) | Anti-fibronectin diabody–IL-2 fusion protein | i.v. (?) | NSCLC | Radiotherapy; surgery | 2 | Not yet recruiting | NCT03705403 (Johannsen et al., 2010; Eigentler et al., 2011; Danielli et al., 2015) | |
| EMD273063/hu14.18-IL2 (Merck) | Anti–GD2–IL-2 fusion protein | i.v. | Melanoma | Surgery | 2 | Active, not recruiting | NCT00590824 | |
| i.t. | Melanoma | Radiotherapy; nivolumab; ipilimumab | 1/2 | Not yet recruiting | NCT03958383 | |||
| i.v. | Neuroblastoma | EEAHD NK cells | 1 | Recruiting | NCT03209869 | |||
| RG7461/RO6874281 (Roche) | Anti–FAP–IL-2 mutein (F42A, Y45A, and L72G) fusion protein | i.v. | NSCLC; SCCHN; ESCC; cervical cancer | Atezolizumab; gemcitabine; vinorelbine | 2 | Recruiting | NCT03386721 (Klein et al., 2017) | |
| i.v. | Pancreatic cancer | Atezolizumab | 1/2 | Recruiting | NCT03193190 (Klein et al., 2017) | |||
| i.v. | TNBC | Atezolizumab | 1/2 | Recruiting | NCT03424005 (Klein et al., 2017) | |||
| i.v. | Melanoma | Pembrolizumab | 1b | Recruiting | NCT03875079 (Klein et al., 2017) | |||
| i.v. | Breast cancer; HNC; other solid tumors | Trastuzumab; cetuximab | 1 | Recruiting | NCT02627274 (Klein et al., 2017) | |||
| i.v. | RCC | Atezolizumab; bevacizumab | 1 | Active, not recruiting | NCT03063762 (Klein et al., 2017) | |||
| RG7813/cergutuzumab amunaleukin (Roche) | Anti–CEA–IL-2 mutein (F42A, Y45A, and L72G) fusion protein | i.v. | Solid tumors | Atezolizumab | 1 | Active, not recruiting | NCT02350673 (Klein et al., 2017; Lo et al., 2017) | |
| PEGylated IL-2 | NKTR-214 (Nektar Therapeutics) | PEG–IL-2 with IL-2Rβ bias > IL-2Rα bias | i.v. | Melanoma | Nivolumab | 3 | Recruiting | NCT03635983 (Charych et al., 2016) |
| i.v. | RCC | Sunitinib; nivolumab; cabozantinib | 3 | Recruiting | NCT03729245 (Charych et al., 2016) | |||
| i.v. | Bladder cancer | Nivolumab | 2 | Recruiting | NCT03785925 (Charych et al., 2016) | |||
| i.v. | Sarcoma | Nivolumab | 2 | Recruiting | NCT03282344 (Charych et al., 2016) | |||
| i.v. | Melanoma; RCC; NSCLC; urothelial cancer; TNBC | Nivolumab; ipilimumab | 1/2 | Recruiting | NCT02983045 (Charych et al., 2016) | |||
| i.v. | Skin cancers (melanoma, MCC); TNBC; ovarian cancer; RCC; CRC; urothelial cancer; sarcoma | NKTR-262; Nivolumab | 1/2 | Recruiting | NCT03435640 (Charych et al., 2016) | |||
| i.v. | NHL | TAK-659 | 1 | Recruiting | NCT03772288 (Charych et al., 2016) | |||
| i.v. | NSCLC; bladder cancer; melanoma | Pembrolizumab; atezolizumab | 1 | Recruiting | NCT03138889 (Charych et al., 2016) | |||
| i.v. | Prostate cancer | Nivolumab | 1 | Recruiting | NCT03835533 (Charych et al., 2016) | |||
| i.v. | Solid tumors | Nivolumab | 1 | Recruiting | NCT03745807 (Charych et al., 2016) | |||
| IL-2 therapy . | Clinical trial . | |||||||
|---|---|---|---|---|---|---|---|---|
| Type . | Agent (company) . | Description . | Delivery route . | Indication . | Co-therapy . | Phase . | Status . | References . |
| Immunocytokine | ALKS 4230 (Alkermes) | IL-2–CD25 fusion protein | i.v. | Solid tumors | Pembrolizumab | 1/2 | Recruiting | NCT02799095 (Vaishampayan et al., 2017) |
| s.c. | Solid tumors | Pembrolizumab | 1 | Recruiting | NCT03861793 (Vaishampayan et al., 2017) | |||
| Darleukin (Philogen) | Anti-fibronectin diabody–IL-2 fusion protein | i.v. (?) | NSCLC | Radiotherapy; surgery | 2 | Not yet recruiting | NCT03705403 (Johannsen et al., 2010; Eigentler et al., 2011; Danielli et al., 2015) | |
| EMD273063/hu14.18-IL2 (Merck) | Anti–GD2–IL-2 fusion protein | i.v. | Melanoma | Surgery | 2 | Active, not recruiting | NCT00590824 | |
| i.t. | Melanoma | Radiotherapy; nivolumab; ipilimumab | 1/2 | Not yet recruiting | NCT03958383 | |||
| i.v. | Neuroblastoma | EEAHD NK cells | 1 | Recruiting | NCT03209869 | |||
| RG7461/RO6874281 (Roche) | Anti–FAP–IL-2 mutein (F42A, Y45A, and L72G) fusion protein | i.v. | NSCLC; SCCHN; ESCC; cervical cancer | Atezolizumab; gemcitabine; vinorelbine | 2 | Recruiting | NCT03386721 (Klein et al., 2017) | |
| i.v. | Pancreatic cancer | Atezolizumab | 1/2 | Recruiting | NCT03193190 (Klein et al., 2017) | |||
| i.v. | TNBC | Atezolizumab | 1/2 | Recruiting | NCT03424005 (Klein et al., 2017) | |||
| i.v. | Melanoma | Pembrolizumab | 1b | Recruiting | NCT03875079 (Klein et al., 2017) | |||
| i.v. | Breast cancer; HNC; other solid tumors | Trastuzumab; cetuximab | 1 | Recruiting | NCT02627274 (Klein et al., 2017) | |||
| i.v. | RCC | Atezolizumab; bevacizumab | 1 | Active, not recruiting | NCT03063762 (Klein et al., 2017) | |||
| RG7813/cergutuzumab amunaleukin (Roche) | Anti–CEA–IL-2 mutein (F42A, Y45A, and L72G) fusion protein | i.v. | Solid tumors | Atezolizumab | 1 | Active, not recruiting | NCT02350673 (Klein et al., 2017; Lo et al., 2017) | |
| PEGylated IL-2 | NKTR-214 (Nektar Therapeutics) | PEG–IL-2 with IL-2Rβ bias > IL-2Rα bias | i.v. | Melanoma | Nivolumab | 3 | Recruiting | NCT03635983 (Charych et al., 2016) |
| i.v. | RCC | Sunitinib; nivolumab; cabozantinib | 3 | Recruiting | NCT03729245 (Charych et al., 2016) | |||
| i.v. | Bladder cancer | Nivolumab | 2 | Recruiting | NCT03785925 (Charych et al., 2016) | |||
| i.v. | Sarcoma | Nivolumab | 2 | Recruiting | NCT03282344 (Charych et al., 2016) | |||
| i.v. | Melanoma; RCC; NSCLC; urothelial cancer; TNBC | Nivolumab; ipilimumab | 1/2 | Recruiting | NCT02983045 (Charych et al., 2016) | |||
| i.v. | Skin cancers (melanoma, MCC); TNBC; ovarian cancer; RCC; CRC; urothelial cancer; sarcoma | NKTR-262; Nivolumab | 1/2 | Recruiting | NCT03435640 (Charych et al., 2016) | |||
| i.v. | NHL | TAK-659 | 1 | Recruiting | NCT03772288 (Charych et al., 2016) | |||
| i.v. | NSCLC; bladder cancer; melanoma | Pembrolizumab; atezolizumab | 1 | Recruiting | NCT03138889 (Charych et al., 2016) | |||
| i.v. | Prostate cancer | Nivolumab | 1 | Recruiting | NCT03835533 (Charych et al., 2016) | |||
| i.v. | Solid tumors | Nivolumab | 1 | Recruiting | NCT03745807 (Charych et al., 2016) | |||
CEA, carcinoembryonic antigen; CRC, colorectal cancer; EEAHD, ex vivo expanded and activated haploidentical donor; ESCC, esophageal squamous cell carcinoma; FAP, fibroblast activation protein-alpha; GD2, ganglioside D2; HNC, head and neck cancer; i.t., intratumoral; MCC, Merkel cell carcinoma; NHL, Non-Hodgkin lymphoma; NSCLC, non-small cell lung cancer; RCC, renal cell carcinoma; SCCHN, squamous cell carcinoma of the head and neck; TNBC, triple negative breast cancer.