Phase 2
N=62
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
Advanced Renal Cell Carcinoma · Metastatic Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03200717 ↗Enrolled (actual)
62
Serious AEs
48.4%
Results posted
Mar 2023
Primary outcome: Primary: Progression Free Survival (PFS) — 7.5; 4.6; 6.8 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pazopanib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
7.5; 4.6; 6.8 | — |
| SECONDARY Overall Response Rate (ORR) Based on Local Investigator Assessment According to RECIST v1.1 |
23.4; 0; 17.7 | — |
| SECONDARY Clinical Benefit Rate (CBR) Based on Local Investigator Assessment According to RECIST v1.1. |
53.2; 40.0; 50.0 | — |
| SECONDARY Overall Survival (OS) |
27.8; 20.0; 23.4 | — |
| SECONDARY Duration of Response (DOR) Based on Local Investigators Assessment According to RECIST v1.1 |
NA | — |
| SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) Score |
-1.3; -0.3; -1.0; -0.5; 1.7; -0.0 | — |
| SECONDARY Change From Baseline in EuroQoL 5-level Instrument Visual Analogue Scale (EQ-5L-5D VAS) Score |
0.1; -1.9; -0.4; -2.8; 3.6; -1.3 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03200717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.