CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 867 enrolled
Drug / intervention
MEDI4736 (Durvalumab) +1 morebiological
Likely dose
Not stated in 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/NCT03084471
NCT03084471Phase 3Completed
CompareCT.gov

An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.

AstraZeneca·interventional·Posted Mar 21, 2017·Updated Dec 22, 2022

In Brief

A Phase 3 clinical trial evaluating MEDI4736 (Durvalumab) and MEDI4736 (Durvalumab) + Tremelimumab for Advanced Solid Malignancies. Completed, enrolled 867 participants across 79 sites in 8 countries.

Detailed Summary

To evaluate the safety, tolerability, and anti-tumor activity of the combination of durvalumab + tremelimumab or durvalumab alone in different solid tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Malignancies
CountriesCanada, France, Germany, Italy, Netherlands, South Korea, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 21, 2017
Enrollment StartJun 5, 2017
Primary CompletionMar 31, 2020
Study CompletionDec 16, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.3 years ago

Interventions

MEDI4736 (Durvalumab)biological

A human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that blocks the interaction of PD-L1 (but not programmed cell death ligand-2) with PD-1 on T cells and CD80 (B7.1) on immune cells (IC).

MEDI4736 (Durvalumab) + Tremelimumabbiological

Durvalumab: A human mAb of IgG 1 kappa subclass that blocks the interaction of PD-L1 (but not programmed cell death ligand-2) with PD-1 on T cells and CD80 (B7.1) on IC. Tremelimumab: A human Ig G2 mAb that completely blocks the interaction of human CTLA-4 (cluster of differentiation \[CD\]152) with CD80 and CD86 and increase release of cytokines (interleukin \[IL\]-2 and interferon \[IFN\]-γ) from human T cells, peripheral blood mononuclear cells and whole blood.