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

NCT03084471 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 867

Last updated 2022-12-22

Study results available
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Summary

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

Conditions

  • Advanced Solid Malignancies

Interventions

BIOLOGICAL

MEDI4736 (Durvalumab)

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).

BIOLOGICAL

MEDI4736 (Durvalumab) + Tremelimumab

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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2020-03-31
Completion
2022-12-16
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • South Korea
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03084471 on ClinicalTrials.gov