Table 1.
Overview of clinical trials involving IL-1 blockade in cancer.
| Identifier | Conditions | Drug | Status | Phase | Initiated |
|---|---|---|---|---|---|
| IL-1 Receptor Antagonists | |||||
| NCT04121442 | Solid Tumors | Isuanakinra + PD-1/ PD-L1 Inhibitor |
Recruiting | Phase I/II | 2019 |
| NCT02550327 | PDAC | Anakinra + Gemcitabine, Cisplatin, Nab-paclitaxcel |
Active, not recruiting | Phase I | 2015 |
| NCT01624766 | Advanced Malignancies | Anakinra + Denosumab, Everolimus |
Active, not recruiting | Phase I | 2012 |
| Anti-IL-1β Antibody | |||||
| Hematological Diseases | |||||
| NCT04239157 | MDS, CMML | Canakinumab | Recruiting | Phase II | 2020 |
| Non-Hematological Diseases | |||||
|
NCT03968419 CANOPY-N |
NSCLC | Canakinumab + Pembrolizumab |
Recruiting | Phase II | 2019 |
|
NCT03631199 CANOPY-1 |
NSCLC | Canakinumab + Pembrolizumab, Chemotherapy |
Active, not recruiting | Phase III | 2018 |
|
NCT03626545 CANOPY-2 |
NSCLC | Canakinumab + Docetaxel |
Active, not recruiting | Phase III | 2018 |
|
NCT03447769 CANOPY-A |
NSCLC | Canakinumab | Recruiting | Phase III | 2018 |
| NCT04581343 | PDAC | Canakinumab + Spartalizumab, Chemotherapy |
Recruiting | Phase I | 2020 |
| NCT04028245 | RCC | Canakinumab + Spartalizumab |
Recruiting | Phase I | 2019 |
| NCT03742349 | TNBC | Spartalizumab + LAG525, Canakinumab |
Recruiting | Phase I | 2018 |
| NCT03484923 | Melanoma | Spartalizumab + LAG525, Capmatinib, Canakinumab, Ribociclib |
Recruiting | Phase II | 2018 |
| NCT02900664 | CRC TNBC NSCLC |
PDR001 + CJM112, EGF816, Canakinumab, Trametinib |
Active, not recruiting | Phase I | 2016 |
| Anti-IL-1α Antibody | |||||
| NCT03207724 | PDAC | Xilonix + 5-FU, Onivyde |
Active, not recruiting | Phase I | 2017 |
| Anti-IL-1R-Antibodies | |||||
| NCT04452214 | Solid Tumors | CAN04 + Pembrolizumab |
Recruiting | Phase I | 2020 |
| NCT03267316 | Solid Tumors | CAN04 ± Cisplastin, Gemcitabine, Nab-paclitaxel |
Recruiting | Phase I/II | 2017 |
Information was obtained from www.clinicaltrials.gov [52]. Terms used: IL-1 blockade, IL-1, IL-1α, IL-1β, cancer, anakinra, canakinumab, xilonix, NLRP3 inhibitor, inflammasome. PDAC, pancreatic ductal adenocarcinoma; CRC, colorectal carcinoma; SMM, smoldering multiple myeloma; IMM, indolent multiple myeloma; MM, multiple myeloma; MDS, myelodysplastic syndrome; CMML, chronic myelomonocytic leukemia; NSCLC, non-small cell lung cancer; TNBC, triple-negative breast cancer; RCC, renal cell carcinoma; PD-1, programmed cell death protein 1; PD-L1, programmed cell death ligand 1; PDR001, anti-PD-1 antibody; CJM112, anti-IL-17A antibody; EGF816, EGFR-inhibitor; trametinib, MEK-inhibitor; LAG525, anti-LAG-3 antibody; capmatinib, MET-inhibitor; ribociclib, CDK4/6-inhibitor, MABp1, monoclonal anti-IL-1α antibody; onivyde, liposomal irinotecan; CAN04, humanized anti-IL-1RAcP antibody.