Trials / Completed
CompletedNCT02493751
A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)
A PHASE 1B, OPEN-LABEL, DOSE-FINDING STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (AG-013736) IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED RENAL CELL CANCER
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab (MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab administered in combination with axitinib is estimated (dose finding portion), the dose expansion phase will be opened to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarker modulation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avelumab (MSB0010718C) | Avelumab with two dose levels: 10 mg/kg IV and 5 mg/kg IV every two weeks to find the maximum tolerated dose in combination with axitinib and continue treatment in a dose expansion. |
| DRUG | Axitinib (AG-013736) | Axitinib with two dose levels: 5 mg and 3 mg oral BID to find the maximum tolerated dose in combination with avelumab and continue treatment in a dose expansion. |
Timeline
- Start date
- 2015-10-26
- Primary completion
- 2018-04-03
- Completion
- 2021-03-04
- First posted
- 2015-07-09
- Last updated
- 2022-02-18
- Results posted
- 2019-06-21
Locations
21 sites across 3 countries: United States, Japan, United Kingdom
Source: ClinicalTrials.gov record NCT02493751. Inclusion in this directory is not an endorsement.