Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Akamis Bio
Study ID
NCT02636036
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • enadenotucirev — BIOLOGICAL
  • nivolumab — BIOLOGICAL

Study Details

This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with focus on CRC, SCCHN, escalation phase), not responding to standard therapy.

Key Dates

Start date
Jan 25, 2016
Status verified
Nov 2021
Primary completion
Oct 8, 2021
Completion
Oct 8, 2021

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: enadenotucirev and nivolumab

Primary Outcome Measure

Incidence, nature and severity of adverse events (safety and tolerability) in study of enadenotucirev administered in combination with a PD-1 inhibitor [ Time Frame: 12 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer Center, 1515 North Campbell Ave.TucsonArizona85724-
City of Hope Comprehensive Cancer Center, 1500 E Duarte Str.DuarteCalifornia91010-
UCLA Medical Center, 10945 Le Conte Ave, Ste. 3360Santa MonicaCalifornia90095-
Horizon Oncology Research, 1345 Unity Place, Suite 365LafayetteIndiana47905-
Henry Ford Hospital, 2799 West Grand Blvd.DetroitMichigan48202-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6307-

Find similar trials in Tucson, AZ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Arizona Cancer Center, 1515 North Campbell Ave.· Tucson, AZCity of Hope Comprehensive Cancer Center, 1500 E Duarte Str.· Duarte, CAUCLA Medical Center, 10945 Le Conte Ave, Ste. 3360· Santa Monica, CAHorizon Oncology Research, 1345 Unity Place, Suite 365· Lafayette, INHenry Ford Hospital, 2799 West Grand Blvd.· Detroit, MIVanderbilt-Ingram Cancer Center· Nashville, TN

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