A Study of MEDI9197 in Subjects With Solid Tumors or CTCL and in Combination With Durvalumab and/or Palliative Radiation in Subjects With Solid Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
MedImmune LLC
Study ID
NCT02556463
Phase
PHASE1
Status
Terminated

Conditions

  • CTCL
  • Cancer
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI9197 — DRUG
    Subjects will receive MEDI9197 (every 4 weeks) as monotherapy (or MEDI9197 every 8 weeks + durvalumab every 4 weeks)(PA6)
  • durvalumab — BIOLOGICAL
    Subjects will receive durvalumab every 4 weeks

Study Details

To evaluate MEDI9197 when administered by intratumoral injection to subjects with solid tumors and in combination with durvalumab in subjects with solid tumors.

Key Dates

Start date
Nov 4, 2015
Status verified
Dec 2018
Primary completion
Oct 26, 2018
Completion
Oct 26, 2018

Study Design

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

Arms

  • Experimental: Escalation MEDI9197
    MEDI9197
  • Experimental: Escalation MEDI9197 with durvalumab
    MEDI9197 in combination with durvalumab
  • Experimental: Escalation MEDI9197 durvalumab radiation
    MEDI9197 in combination with durvalumab and palliative radiation
  • Experimental: MEDI9197 with palliative radiation
    MEDI9197 in combination with palliative radiation

Primary Outcome Measure

Safety and tolerability as determined by assessment of dose limiting toxicities and the maximum tolerated dose or maximal assessed dose per protocol of MEDI9197 when administered by intratumoral injection to subjects with solid tumor cancers [ Time Frame: From time of informed consent through 4 weeks after last dose of investigational product ]

Locations (8)

FacilityCityStateZIPSite coordinators
Research SiteSan FranciscoCalifornia94115-
Research SiteAuroraColorado80045-
Research SiteMinneapolisMinnesota55455-
Research SiteSt LouisMissouri63110-
Research SiteNew YorkNew York10029-
Research SiteChapel HillNorth Carolina27599-7305-
Research SitePhiladelphiaPennsylvania19104-
Research SiteHoustonTexas77030-

Find similar trials in San Francisco, CA

By research site
Research Site· San Francisco, CAResearch Site· Aurora, COResearch Site· Minneapolis, MNResearch Site· St Louis, MOResearch Site· New York, NYResearch Site· Chapel Hill, NC

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