CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
MK-3475 +3 moredrug
Likely dose
MK-3475 200mgfrom 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/NCT02348008
NCT02348008Phase 2Completed
CompareCT.gov

Phase Ib and Phase II Studies of Anti-PD-1 Antibody MK-3475 in Combination With Bevacizumab for the Treatment of Metastatic Renal Cell Carcinoma: Big Ten Cancer Research Consortium GU14-003

Arkadiusz Z. Dudek, MD·interventional·Posted Jan 28, 2015·Updated Sep 14, 2022

In Brief

A Phase 2 clinical trial evaluating MK-3475 and Bevacizumab for Clear Cell Renal Carcinoma. Completed, enrolled 61 participants across 9 sites.

Detailed Summary

This is an open label, multi-institutional, single arm study of dose escalation phase Ib cohort, followed by a phase II cohort of anti-PD-1 antibody MK-3475 in combination with bevacizumab. No randomization or blinding is involved.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClear Cell Renal Carcinoma
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, Big Ten Cancer Research Consortium

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 28, 2015
Enrollment StartMar 1, 2015
Primary CompletionDec 5, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.4 years ago

Interventions

MK-3475drug

Arm A: Phase 1b Cohort 1: 200mg IV; Arm A: Phase 1b Cohort 2: 200mg IV

Bevacizumabdrug

Arm A: Phase 1b Cohort 1: 10mg IV; Arm A: Phase 1b Cohort 2: 15mg IV

MK-3475drug

Arm B: Phase II Treatment: 200mg IV

Bevacizumabdrug

Arm B: Phase II Treatment: administered at the maximum safe dose of 10mg or 15mg as established in the Phase 1b dose escalation cohort study.