Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
AstraZeneca
Study ID
NCT02558894
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MEDI4736 monotherapy — DRUG
    MEDI4736 via IV infusion.
  • tremelimumab+MEDI4736 — DRUG
    tremelimumab+MEDI4736 via IV infusion.

Study Details

A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.

Key Dates

Start date
Nov 16, 2015
Status verified
Jul 2018
Primary completion
Jun 15, 2017
Completion
Jun 15, 2017

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MEDI4736 monotherapy
    MEDI4736 via IV infusion.
  • Experimental: tremelimumab+MEDI4736
    MEDI4736+tremelimumab via IV infusion.

Primary Outcome Measure

Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteTampaFlorida33612-
Research SiteNew YorkNew York10065-

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