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

PHASE3CompletedINTERVENTIONAL
Enrollment

867

Participants

Timeline

Start Date

June 5, 2017

Primary Completion Date

March 31, 2020

Study Completion Date

December 16, 2022

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."

Trial Locations (79)

6189

Research Site, Nice

10408

Research Site, Goyang-si

11733

Research Site, East Setauket

13005

Research Site, Marseille

13585

Research Site, Berlin

20007

Research Site, Washington D.C.

20089

Research Site, Rozzano

20141

Research Site, Milan

20246

Research Site, Hamburg

21034

Research Site, Dijon

24060

Research Site, Blacksburg

24116

Research Site, Kiel

25030

Research Site, Besançon

29607

Research Site, Greenville

29609

Research Site, Brest

30029

Research Site, Nîmes

31059

Research Site, Toulouse

33075

Research Site, Bordeaux

33076

Research Site, Bordeaux

33100

Research Site, Udine

33332

Research Site, Gütersloh

33611

Research Site, Bielefeld

34298

Research Site, Montpellier

35128

Research Site, Padua

37044

Research Site, Tours

37920

Research Site, Knoxville

41124

Research Site, Modena

44805

Research Site, Saint-Herblain

45136

Research Site, Essen

47014

Research Site, Meldola

47179

Research Site, Duisburg

48100

Research Site, Ravenna

48149

Research Site, Münster

49241

Research Site, Busan

52100

Research Site, Arezzo

56126

Research Site, Pisa

59000

Research Site, Lille

60126

Research Site, Ancona

60487

Research Site, Tinley Park

67065

Research Site, Strasbourg

68130

Research Site, Omaha

69373

Research Site, Lyon

69495

Research Site, Pierre-Bénite

70124

Research Site, Bari

70174

Research Site, Stuttgart

73100

Research Site, Lecce

75010

Research Site, Paris

76031

Research Site, Rouen

83100

Research Site, Avellino

86021

Research Site, Poitiers

91054

Research Site, Erlangen

94805

Research Site, Villejuif

95126

Research Site, Catania

95403

Research Site, Santa Rosa

97080

Research Site, Würzburg

99208

Research Site, Spokane

07601

Research Site, Hackensack

E1C 6Z8

Research Site, Moncton

L6R 3J7

Research Site, Brampton

L8V 5C2

Research Site, Hamilton

K7L 5P9

Research Site, Kingston

N6A 4L6

Research Site, London

L3Y 2P9

Research Site, Newmarket

M4N 3M5

Research Site, Toronto

M5G 2M9

Research Site, Toronto

J4V 2H1

Research Site, Greenfield Park

G1R 2J6

Research Site, Québec

01307

Research Site, Dresden

07747

Research Site, Jena

00128

Research Site, Roma

00152

Research Site, Roma

2333 ZA

Research Site, Leiden

03722

Research Site, Seoul

05505

Research Site, Seoul

EC1A 7BE

Research Site, London

W1G 6AD

Research Site, London

W6 8RF

Research Site, London

NE7 7DN

Research Site, Newcastle

S10 2SJ

Research Site, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY