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COMPLETED Phase 1

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

NCT02636036 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • BIOLOGICAL nivolumab
  • BIOLOGICAL enadenotucirev

Study Locations (6)

California

  • City of Hope Comprehensive Cancer Center, 1500 E Duarte Str. — Duarte
  • UCLA Medical Center, 10945 Le Conte Ave, Ste. 3360 — Santa Monica

Arizona

  • University of Arizona Cancer Center, 1515 North Campbell Ave. — Tucson

Indiana

  • Horizon Oncology Research, 1345 Unity Place, Suite 365 — Lafayette

Michigan

  • Henry Ford Hospital, 2799 West Grand Blvd. — Detroit

Tennessee

  • Vanderbilt-Ingram Cancer Center — Nashville

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2016-01-25
Est. Completion 2021-10-08
Phase Phase 1

Sponsor

Akamis Bio

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02636036

The ClinicalTrials.gov registry entry for NCT02636036 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akamis Bio, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02636036 reports 6 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02636036 about?

NCT02636036 is a clinical study titled "Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors". 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.

What is the current status of trial NCT02636036?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2016-01-25. Estimated completion is 2021-10-08.

What conditions does trial NCT02636036 study?

This clinical trial studies the following conditions: Colorectal Cancer, Squamous Cell Carcinoma of the Head and Neck, Epithelial Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02636036?

The interventions under investigation include: nivolumab (BIOLOGICAL), enadenotucirev (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02636036?

This trial is sponsored by Akamis Bio, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02636036 being conducted?

This trial has 6 study locations across Arizona, California, Indiana, Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial