A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)
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|ClinicalTrials.gov Identifier: NCT02493751|
Recruitment Status : Active, not recruiting
First Posted : July 9, 2015
Results First Posted : June 21, 2019
Last Update Posted : May 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Cancer||Drug: Avelumab (MSB0010718C) Drug: Axitinib (AG-013736)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 15, 2015|
|Actual Primary Completion Date :||April 3, 2018|
|Estimated Study Completion Date :||January 22, 2021|
Experimental: Dose finding phase and dose expansion phase.
To test the maximum tolerated dose of avelumab (MSB0010718C) in combination with axitinib (AG-013736)
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.
- Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: DLT observation period (from the beginning of Cycle 1 up to the end of Cycle 2 [28 days]) ]DLT: greater than or equal to (>=) Grade 3 hematologic/non-hematologic toxicity, Grade 3-4 liver-related laboratory test elevation (alanine aminotransferase, aspartate aminotransferase) with Grade 2 elevation of total bilirubin, non-hematologic Grade 3 laboratory abnormality (required medical intervention to treat participant/led to hospitalization), inability to complete >=75% of first 2 cycles doses of axitinib (from Cycle 1 Day 1 after completion of lead-in period) or 2 infusions of avelumab within DLT observation period due to investigational product related toxicity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493751
|Study Director:||Pfizer CT.gov Call Center||Pfizer|