Clinical trial · Interventional
Study of Efficacy, Safety, and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Prior Checkpoint Inhibitor Treatment
A Prospective International Multicenter Phase II Study to Evaluate the Efficacy, Safety and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Previous Therapy With Checkpoint Inhibitor Treatment
- 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)
The main purpose of this study was to assess the progression-free survival (PFS) based on local investigator assessment of pazopanib in participants with advanced and/or metastatic renal cell carcinoma (mRCC) following prior treatment with immune checkpoint inhibitors (ICI).
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 |
|---|---|---|---|
| Advanced Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pazopanib | Drug | Pazopanib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pazopanib- 2nd line treatment
- description
- Participants received pazopanib as 2nd line treatment
- interventionNames
- Drug: Pazopanib
- type
- EXPERIMENTAL
- label
- Pazopanib- 3rd line treatment
- description
- Participants received pazopanib as 3rd line treatment
- interventionNames
- Drug: Pazopanib
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Date of first treatment to date of progression or death up to approximately 38 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically confirmed locally recurrent or metastatic predominantly clear cell renal cell carcinoma. * Measurable disease based on RECIST 1.1 criteria * Prior systemic therapy with an immune checkpoint inhibitor (monotherapy or combination) as 1st or 2nd line RCC treatment. Note: patients with prior mTOR inhibitor or TKI treatment as monotherapy or in combination with immune checkpoint inhibitor were allowed; however, treatment with immune checkpoint inhibitor (monotherapy or in combination) must have been the last treatment prior to study entry. * Last dose of immune checkpoint inhibitor therapy received 4 or more weeks before start of study treatment * Karnofsky performance status ≥70%. * Potassium, sodium, calcium and magnesium within normal limits of the central laboratory Key Exclusion Criteria: * Renal cell carcinoma without any clear (conventional) cell component * History or evidence of central nervous system (CNS) metastases (patients with pretreated metastases were eligible under certain conditions) * Prior treatment with pazopanib * Prior treatment with bevacizumab that was not given in combination with immune checkpoint inhibitor therapy. * Prior treatment with more than 2 lines of therapy (combination treatments were considered 1 line of therapy) * Not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery was defined as ≤ NCI-CTCAE Grade 1, except for liver function test levels which must be \<Grade 1. * Disease recurrence less than 6 months from the last dose of prior neoadjuvant or adjuvant therapy (including VEGF-R TKI) * Patients receiving prohibited concomitant medications that could not be discontinued or replaced by safe alternative medication at least 5 half-lives of the concomitant medication or 7 days, whichever was longer, prior to the start of pazopanib treatment. * Administration of any investigational drug within 4 weeks prior to the first dose of study treatment
References
Publications (0)
Data not yet available