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

Part of paid clinical trials in Santa Rosa, California.

Sponsor
AstraZeneca
Study ID
NCT03084471
Phase
PHASE3
Status
Completed

Conditions

  • Advanced Solid Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

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) + Tremelimumab — BIOLOGICAL
    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.

Study Details

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

Key Dates

Start date
Jun 5, 2017
Status verified
Dec 2022
Primary completion
Mar 31, 2020
Completion
Dec 16, 2022

Study Design

Enrollment
867 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination therapy
    Combination therapy (durvalumab + tremelimumab) : Patients will receive the combination therapy followed by monotherapy via intravenous (IV) infusion once Q4W: * Durvalumab 1,500 mg + tremelimumab 75 mg on Week 0, for up to a maximum of 4 doses (or cycles) and * Durvalumab 1,500 mg starting 4 weeks after the last infusion of the combination or discontinuation of tremelimumab.
  • Experimental: Monotherapy
    Monotherapy (Durvalumab 1,500 mg): Patients will receive durvalumab 1,500 mg via IV infusion Q4W on Week 0.

Primary Outcome Measure

Number of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: From screening to safety follow up visit (90 days after last dose), up to approximately 3 years. ]

Locations (10)

FacilityCityStateZIPSite coordinators
Research SiteSanta RosaCalifornia95403-
Research SiteWashington D.C.District of Columbia20007-
Research SiteTinley ParkIllinois60487-
Research SiteOmahaNebraska68130-
Research SiteHackensackNew Jersey07601-
Research SiteEast SetauketNew York11733-
Research SiteGreenvilleSouth Carolina29607-
Research SiteKnoxvilleTennessee37920-
Research SiteBlacksburgVirginia24060-
Research SiteSpokaneWashington99208-

Find similar trials in Santa Rosa, CA

By research site
Research Site· Santa Rosa, CAResearch Site· Washington D.C., DCResearch Site· Tinley Park, ILResearch Site· Omaha, NEResearch Site· Hackensack, NJResearch Site· East Setauket, NY

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