A Study to Evaluate MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors

Part of paid clinical trials in Santa Monica, California.

Sponsor
MedImmune LLC
Study ID
NCT02705482
Phase
PHASE1
Status
Completed

Conditions

  • Select Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI0562 — BIOLOGICAL
    Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
  • Tremelimumab — BIOLOGICAL
    Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
  • Durvalumab — BIOLOGICAL
    Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.

Study Details

The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.

Key Dates

Start date
Mar 30, 2016
Status verified
Aug 2019
Primary completion
Aug 7, 2019
Completion
Aug 7, 2019

Study Design

Enrollment
58 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: MEDI0562 and durvalumab
    MEDI0562 and durvalumab
  • Experimental: Arm B: MEDI0562 and tremelimumab
    MEDI0562 and tremelimumab

Primary Outcome Measure

Safety as defined by the presence of adverse events (AE), serious adverse events (SAE), and dose limiting toxicities (DLT). [ Time Frame: From time of informed consent through 12 weeks after ending treatment with investigational product ]

Locations (9)

FacilityCityStateZIPSite coordinators
Research SiteSanta MonicaCalifornia90404-
Research SiteChicagoIllinois60611-
Research SiteSt LouisMissouri63110-
Research SiteAlbuquerqueNew Mexico87106-
Research SiteNew YorkNew York10032-
Research SiteHuntersvilleNorth Carolina28078-
Research SitePortlandOregon97213-
Research SiteNashvilleTennessee37203-
Research SiteHoustonTexas77030-

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