Clinical trial · Interventional
Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
An Open Label, Dose Escalation Safety and Tolerability Trial of the Combination of s.c. Recombinant Human IL-21 (rIL-21) and Sunitinib (Phase 1) Followed by an Open Label Stratified Randomized 2-arm Trial of rIL-21 Plus Sunitinib Versus Sunitinib Alone (Phase 2a) in Subjects With Stage IV Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase 1/2a trial is conducted in Europe. The first part of the trial is a dose escalation safety trial determining the maximum tolerated dose of rIL-21 when administered in combination with sunitinib. The second part, scheduled to start in September 2008, is a randomised 2-arm trial comparing the anti-tumour effect of rIL-21 plus sunitinib with sunitinib alone.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interleukin-21 | Drug | — | UNRESOLVED |
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: recombinant interleukin-21
- Drug: sunitinib
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: sunitinib
- Drug: recombinant interleukin-21
- type
- EXPERIMENTAL
- label
- C
- interventionNames
- Drug: sunitinib
- Drug: recombinant interleukin-21
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified and surgically incurable stage IV Renal Cell Carcinoma * ECOG performance status of 0 or 1 (i.e. good performance status) * Life expectancy of at least 3 months Exclusion Criteria: * Prior systemic therapy for metastatic disease * Radiotherapy within the last 4 weeks prior to start of treatment * Receipt of any investigational drug within 3 months of starting treatment * History of any other active malignancy within five years prior to enrolment
References
Publications (0)
Data not yet available