A Study of MEDI9197 in Participants with Solid Tumors or CTCL and in Combination with Durvalumab and/or Palliative Radiation in Participants with Solid Tumors

Study identifier:D6410C00001

ClinicalTrials.gov identifier:NCT02556463

EudraCT identifier:2015-005783-41

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase I, First-Time-in-Human Study of MEDI9197, a TLR 7/8 Agonist, Administered Intratumorally as a Single Agent in Subjects with Solid Tumors or CTCL and in Combination with Durvalumab and/or Palliative Radiation in Subjects with Solid Tumors

Medical condition

Solid Tumors

Phase

Phase 1

Healthy volunteers

No

Study drug

MEDI9197, MEDI9197, MEDI9197, MEDI9197, MEDI9197, MEDI9197, MEDI9197, MEDI9197, MEDI9197, MEDI9197, MEDI9197, Durvalumab, Durvalumab, Durvalumab, Durvalumab

Sex

All

Actual enrollment

53

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 04 Nov 2015
Primary Completion Date: 26 Oct 2018
Study Completion Date: 26 Oct 2018

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2019 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria