CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 97 enrolled
Drug / intervention
MEDI0680 +2 morebiological
Likely dose
MEDI0680 20 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/NCT02118337
NCT02118337Phase 2Completed

A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies

MedImmune LLC·interventional·Posted Apr 21, 2014·Updated Jun 1, 2021

In Brief

A Phase 2 clinical trial evaluating MEDI0680, Durvalumab, and 1 other intervention for Select Advanced Malignancies and 2 related conditions. Completed, enrolled 97 participants across 27 sites in 6 countries.

Detailed Summary

To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, France, Netherlands, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 21, 2014
Enrollment StartMay 19, 2014
Primary CompletionMar 17, 2020
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 12.2 years ago

Interventions

MEDI0680biological

Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase.

Durvalumabbiological

Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase.

Nivolumabbiological

Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase.