Recent Updates
Recently added Catalysts

recombinant interleukin-21

Phase 2

Cancer | Small molecule | Oncology |Novo Nordisk A/S|Last Updated: Aug 14, 2023

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials3
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

recombinant interleukin-21 · 3 trials · 4 indications

Phase 2 3
NCT00523380Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian CancerCancer
COMPLETED10 Analytics
NCT00617253Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma PatientsCancer
COMPLETED9 Analytics
NCT00336986Efficacy Study of IL-21 to Treat Metastatic MelanomaCancer
COMPLETED54 Analytics
PHASE2COMPLETED
Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer
CancerUnlock trial analytics
PHASE2COMPLETED
Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
CancerUnlock trial analytics
PHASE2COMPLETED
Efficacy Study of IL-21 to Treat Metastatic Melanoma
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
after max. 6 treatment cycles
Toxicity according to CTCAE version 3.0
For the duration of the trial
Tumor size assessed according to international criteria
After 8 weeks

Secondary Endpoints

Pharmacokinetics
Initially
IL-21 antibody formation
For the duration of the trial
Progression free survival
For the duration of the trial
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
CEXPERIMENTAL -
DEXPERIMENTAL -

Interventions

NameTypeDescription
recombinant interleukin-21DRUGAdministered i.v. in treatment cycles of 28 days.
caelyx (pegylated liposomal doxorubicin)DRUGAdministered i.v. in treatment cycles of 28 days.
sunitinibDRUGHard gelatine capsules, 12.5 mg
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Advanced epithelial Ovarian Cancer (stage IIB-IV) * Persistent or progressive disease after or relapse within one year of completion of first line therapy * Measurable or assessable disease * Eastern Cooperative Oncology Group status less than or equal to 2 Exclusion Criteria...

Countries:FranceGermanyNetherlandsAustralia
Unlock Eligibility Criteria

Frequently asked questions about recombinant interleukin-21

What is recombinant interleukin-21 used for?

Recombinant interleukin-21 is an investigational cancer therapy being developed by Novo Nordisk A/S (NVO). It has been studied in Phase 2 clinical trials for malignant melanoma, ovarian cancer, and renal cell carcinoma. The drug is not approved and remains in clinical development.

What does recombinant interleukin-21 target?

Recombinant interleukin-21 is a form of the cytokine interleukin-21, which modulates immune responses. It is being studied for its potential to stimulate the immune system against cancer cells. The drug targets the interleukin-21 receptor pathway to enhance anti-tumor immunity.

Who makes recombinant interleukin-21?

Recombinant interleukin-21 is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company has sponsored Phase 2 clinical trials evaluating the drug in various cancer indications.

What phase is recombinant interleukin-21 in?

Recombinant interleukin-21 is in Phase 2 clinical development. It has completed three Phase 2 trials, with no active trials currently ongoing. The drug is investigational and has not received FDA approval.

What clinical trials is recombinant interleukin-21 in?

Recombinant interleukin-21 has been studied in three completed Phase 2 trials: NCT00336986 for metastatic melanoma, NCT00523380 for ovarian cancer, and NCT00617253 for renal cell carcinoma in combination with sunitinib. These trials enrolled a total of 73 participants.

Is recombinant interleukin-21 the same as IL-21?

Recombinant interleukin-21 is also known as IL-21 or rIL-21. It is a recombinant form of the naturally occurring cytokine interleukin-21. The drug has been studied under these names in clinical trials for cancer.