CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 enrolled
Drug / intervention
Axitinib +1 moredrug
Likely dose
Axitinib 5 mgfrom 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/NCT02133742
NCT02133742Phase 1Completed
CompareCT.gov

A PHASE 1B, OPEN LABEL, DOSE FINDING STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AXITINIB (AG-013736) IN COMBINATION WITH PEMBROLIZUMAB (MK-3475) IN PATIENTS WITH ADVANCED RENAL CELL CANCER

Pfizer·interventional·Posted May 8, 2014·Updated Jul 28, 2021

In Brief

A Phase 1 clinical trial evaluating Axitinib and MK-3475 for Renal Cell Carcinoma. Completed, enrolled 52 participants across 19 sites.

Detailed Summary

Despite substantial improvements of patients outcome in advanced RCC, durable and complete response is uncommon. The majority of patients eventually develop resistance and exhibit disease progression. Combining a PD-1 inhibitor, which has shown single-agent efficacy with axitinib may provide additional clinical benefit compared to axitinib alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 8, 2014
Enrollment StartSep 16, 2014
Primary CompletionMar 31, 2017
Study CompletionJul 3, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.2 years ago

Interventions

Axitinibdrug

Axitinib at starting dose of 5 mg and 3 mg BID.

MK-3475drug

MK-3475 with two dose levels: 2 mg/kg every three weeks to find the maximum tolerated dose and continue treatment in a dose expansion phase.