CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 55 enrolled
Drug / intervention
Avelumab (MSB0010718C) +1 moredrug
Likely dose
Avelumab (MSB0010718C) 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02493751
NCT02493751Phase 1Completed
CompareCT.gov

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

Pfizer·interventional·Posted Jul 9, 2015·Updated Feb 18, 2022

In Brief

A Phase 1 clinical trial evaluating Avelumab (MSB0010718C) and Axitinib (AG-013736) for Renal Cell Cancer. Completed, enrolled 55 participants across 21 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Cancer
CountriesJapan, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 9, 2015
Enrollment StartOct 26, 2015
Primary CompletionApr 3, 2018
Study CompletionMar 4, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.0 years ago

Interventions

Avelumab (MSB0010718C)drug

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.

Axitinib (AG-013736)drug

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.