Review Article

IL-21: A Pleiotropic Cytokine with Potential Applications in Oncology

Table 1

Clinical studies of IL-21 immunotherapy.

Clinical trialPhaseInterventionStatusResults

NN02816141A two-arm phase I study of IL-21 in metastatic melanomaCompletedMTD established at 30 g/kg. Increased biomarkers (sCD25, perforin granzyme).
One PR that became CR 3 months later [136].

NCT006172531/2Combination of rIL-21 and sunitinib in stage IV renal cell carcinoma patientsCompletedThe tolerated dose of IL-21 (3 mg/kg) was too low and the study was discontinued [145].

NCT000951081/2Study of IL-21 for metastatic malignant melanoma and metastatic kidney cancerCompletedMelanoma: 1 CR and 11SD out of 24.
Renal cancer: 4PR and 13SD out of 19 [138]

NCT003892851/2Study of i.v. rIL-21 in combination with oral sorafenib for metastatic renal cell carcinomaCompletedORR 21% disease control rate 82% IL-21 plus sorafenib has antitumor activity and acceptable safety [146]

NCT003479711Study of rIL-21 in combination with Rituxan for relapsed/refractory low-grade B cell lymphoma CompletedORR 42% (3 CR and 5PR out of 19 patients) [143]

NCT005140852IL-21 in treating patients with metastatic or recurrent malignant melanomaCompletedORR 22.5% and 16 SD out of 40 patients [141]

NCT003369862Efficacy study of IL-21 to treat metastatic melanomaCompletedORR 8%, increased biomarkers [137]

NCT005233802Efficacy study of rIL-21 plus doxil in the treatment of ovarian cancerCompletedNo data available

NCT006018612Effect of rIL-21 on metastases in lymph nodes in melanoma skin cancerTerminatedNo data available

NCT011527882A randomized phase II study of rIL-21 versus dacarbazine in patients with metastatic or recurrent melanomaActive, not recruitingrIL-21 is comparable to DTIC in this patient population (4/30 = 13.3% 4/28 = 14.3%) [142]

NCT014890591Safety study of IL-21/ipilimumab combination in the treatment of melanomaCompletedNo data available

NCT016297581Safety study of IL-21/anti-PD-1 combination in the treatment of solid tumorsActive, not recruitingNo data available

NCT017874741/2IL-21-expanded NK cells for induction of acute myeloid leukemia (AML)RecruitingNo data available