MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
MedImmune LLC
Study ID
NCT03089645
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 101 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI5083 monotherapy — BIOLOGICAL
    Dose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab
  • MEID5083 with Durvalumab or Tremelimumab — BIOLOGICAL
    Sequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab
  • Medi5083 with Durvalumab and Docetaxel — BIOLOGICAL
    Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel

Study Details

The purpose of this study is to evaluate the safety, pharmacokinetics and Immunogenicity of Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult subjects with advanced solid tumors.

Key Dates

Start date
Mar 21, 2017
Status verified
Jul 2020
Primary completion
Jun 23, 2020
Completion
Jun 23, 2020

Study Design

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

Arms

  • Experimental: Part 1
    MEDI5083 monotherapy followed by Durvalumab monotherapy in subjects with advanced solid tumors
  • Experimental: Part 2
    Sequential MEDI5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab in subjects with advanced solid tumors.
  • Experimental: Part 3
    Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel in subjects with IO refractory/relapsed 2/3L in NSCLC

Primary Outcome Measure

Number of participants with Adverse Events (AEs) as a measure of safety [ Time Frame: From the time of consent through 120 days after last treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
Research SiteHackensackNew Jersey07601-2191-
Research SiteProvidenceRhode Island02903-
Research SiteNashvilleTennessee37203-
Research SiteSalt Lake CityUtah84112-

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