Clinical trial · Interventional
PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma
A PHASE II TRIAL OF PF-04856884 (CVX-060), A SELECTIVE ANGIOPOIETIN-2 (ANG-2) INHIBITOR IN COMBINATION WITH AG-013736 (AXITINIB) IN PATIENTS WITH PREVIOUSLY TREATED METASTATIC RENAL CELL CARCINOMA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): See termination reason in detailed description.
Summary
Brief summary (as posted)
To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736) in patients that have received one prior systemic regimen for metastatic renal cell carcinoma (mRCC) vs. axitinib alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axitinib (AG-013736) | Drug | Axitinib | ALIAS |
| PF-04856884 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM A
- description
- PF-04856884 in combination with AG-013736
- interventionNames
- Biological: PF-04856884
- Drug: Axitinib (AG-013736)
- type
- ACTIVE_COMPARATOR
- label
- ARM B
- description
- AG-013736 alone
- interventionNames
- Drug: Axitinib (AG-013736)
Primary outcomes (3)
- measure
- Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult male or female patients with histologically or cytologically confirmed renal cell cancer (RCC) with a component of clear cell subtype and evidence of metastasis * Evidence of unidimensionally measurable disease * Prior therapy: Part I: Having received 1 to 3 prior systemic regimens for treatment of mRCC * Part II: Evidence of disease progression following 1 prior regimen administered as 1st line therapy for mRCC. The prior regimen must have contained one of the following: VEGFR2 tyrosine kinase inhibitor (TKI) or other anti VEGF \[Vascular Endothelial Growth Factor\] compounds, such as bevacizumab * adequate bone marrow, liver and renal function Exclusion Criteria: Part I: * Intolerant to prior AG 013736 therapy or prior treatment with compounds which contain the core platform antibody as PF 04856884 Part II: * Prior AG 013736 therapy, more than one systemic first-line regimen for the treatment of mRCC and prior treatment with compounds which contain the core platform antibody as PF 04856884 * major surgery \<4 weeks or radiation therapy \<2 weeks prior to start of therapy * clinically significant gastrointestinal abnormalities * current use or anticipated need for drugs that are known potent CYP3A4 inhibitors and drugs that are known CYP3A4 or CYP1A2 inducers * history of bleeding diathesis or coagulopathy * Grade 3 or greater hemorrhage from any cause \<4 weeks prior to screening; * hemoptysis \>½ teaspoon of blood per day within 2 weeks prior to screening.
References
Publications (0)
Data not yet available