Table 1. Clinical trials recently launched to evaluate the safety and efficacy of immunostimulatory cytokines in cancer patients*.
| Cytokine | Indication(s) | Status | Phase | Route | Notes | Ref. |
|---|---|---|---|---|---|---|
| FLT3L | Lymphoma | Recruiting | II | i.t. | Combined with radiotherapy and a TLR3 agonist |
NCT01976585 |
| GM-CSF | Breast carcinoma Ovarian carcinoma |
Recruiting | I/II | s.c. | Combined with a FOLR1- targeting vaccine |
NCT02019524 |
| Follicular B-cell lymphoma | Completed | II | s.c. | Combined with rituximab | NCT01939730 | |
| GBM | Not yet recruiting | I/II | n.a. | Combined with multipeptide vaccine and imiquimod |
NCT02078648 | |
| GBM Gliosarcoma |
Not yet recruiting | II | s.c. | Combined with a cell-based vaccine, bevacizumab and cyclophosphamide | NCT01903330 | |
| Melanoma | Completed | III | s.c. | As single agent or combined with TYR-targeting vaccine |
NCT01989572 | |
| Recruiting | I/II | n.a. | Combined with ipilimumab | NCT02009397 | ||
| Mesothelioma | Recruiting | II | s.c. | Combined with a WT1-targeting vaccine | NCT01890980 | |
| NSCLC | Recruiting | II | n.a. | Combined with an autophagosome- derived vaccine and imiquimod |
NCT01909752 | |
| IFN-α IFN-α2b |
AML | Recruiting | IV | n.a. | As single agent upon allogeneic stem cell transplantation |
NCT02027064 |
| Gastrointestinal neuroendocrine tumors |
Not yet recruiting | III | s.c. | As single agent | NCT01860742 | |
| Anal intraepithelial neoplasia | Recruiting | I/II | s.c. | Combined with a HPV-16-targeting vaccine | NCT01923116 | |
| Childhood craniopharyngioma | Not yet recruiting | II | s.c. | As single agent | NCT01964300 | |
| CML | Not yet recruiting | II | n.a. | Combined with dasatinib | NCT01872442 | |
| Not yet recruiting | II | s.c. | Combined with imatinib and nilotinib | NCT02001818 | ||
| Recruiting | I | s.c. | Combined with imatinib | NCT01933906 | ||
| Recruiting | II | s.c. | Combined with nilotinib | NCT01866553 | ||
| Melanoma RCC |
Not yet recruiting | I/II | s.c. | Combined with anti-PDCD1 mAb | NCT02089685 | |
| IFNγ | Soft tissue sarcoma | Recruiting | n.a. | s.c. | As single agent | NCT01957709 |
| IL-2 | AML | Not yet recruiting | I | s.c. | Combined with adoptively transferred NK cells |
NCT01898793 |
| Breast carcinoma Gastric carcinoma |
Recruiting | I/II | s.c. | Combined with adoptively transferred NK cells and trastuzumab |
NCT02030561 | |
| Melanoma | Recruiting | II | i.t. | As an L19-fused immunocytokine combined with L19-TNFα |
NCT02076633 | |
| Merkel cell carcinoma | Recruiting | II | i.v. | As an F16-fused immunocytokine combined with paclitaxel |
NCT02054884 | |
| Multiple myeloma | Recruiting | II | n.a. | Combined with adoptively transferred NK cells |
NCT01884688 | |
| Neuroblastoma | Recruiting | II | s.c. | Coupled to an anti-GD2 mAb, G-CSF and GM-CSF for the treatment of MRD | NCT01857934 | |
| NHL | Recruiting | I/II | s.c. | As a CD20-targeting immunocytokine | NCT01874288 | |
| NSCLC | Not yet recruiting | I | i.v. | As an L19-fused immunocytokine after SABR |
NCT02086721 | |
| Prostate cancer | Recruiting | I/II | n.a. | Combined with FOLH1-specific CAR-expressing T cells |
NCT01929239 | |
| Solid tumors | Not yet recruiting | I | s.c. | Combined with NY-ESO-1-targeted PBLs and ipilimumab |
NCT02070406 | |
| Recruiting | I | i.v. | As a CEA-targeting immunocytokine | NCT02004106 | ||
| II | n.a. | Combined with NY-ESO-1-targeted PBLs | NCT01967823 | |||
| IL-7 | Prostate cancer | Not yet recruiting | II | s.c. | Combined with sipuleucel-T | NCT01881867 |
| IL-10 | Solid tumors | Recruiting | I | s.c. | As single agent | NCT02009449 |
| IL-15 | Solid tumors | Recruiting | I | i.v. | Combined with autologous activated NK cells |
NCT01875601 |
Abbreviations: AML, acute myeloid leukemia; CAR, chimeric antigen receptor; CEA, carcinoembryonic antigen; CML, chronic myeloid leukemia; FLT3L, fms-related tyrosine kinase 3 ligand; FOLH1, folate hydrolase 1; FOLR1, folate receptor 1; GBM, glioblastoma multiforme; GM-CSF, granulocyte macrophage colony-stimulating factor; HPV-16, human papillomavirus Type 16; IFN, interferon; IL, interleukin; i.t., intra tumorem; i.v., intra venam; mAb, monoclonal antibody; MRD, minimal residual disease; n.a., not available; NHL, non-Hodgkin lymphoma; NK, natural killer; NSCLC, non-small cell lung carcinoma; PBL, peripheral blood lymphocyte; PDCD1, programmed cell death 1; RCC, renal cell carcinoma; SABR, stereotactic ablative body radiotherapy; s.c., sub cutem; TNFα, tumor necrosis factor α; TYR, tyrosinase; WT1, Wilms tumor 1. *Between 2013, May 1st and the date of submission.