Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02636036 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Colorectal Cancer and Squamous Cell Carcinoma of the Head and Neck, sponsored by Akamis Bio.

Completed
Registry status
Phase 1
Development phase
51
Enrollment target
6
Study locations

NCT02636036: Completed Phase 1 study of Colorectal Cancer and Squamous Cell Carcinoma of the Head and Neck, sponsored by Akamis Bio.

NCT02636036 is a Phase 1 study of Colorectal Cancer and Squamous Cell Carcinoma of the Head and Neck that has completed, run by Akamis Bio. The registered enrollment target is 51 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02636036, a Phase 1 study of Colorectal Cancer and Squamous Cell Carcinoma of the Head and Neck, has completed, sponsored by Akamis Bio.

COMPLETED
Registry status
Phase 1
Development phase
51 participants
Enrollment target
6
Study locations

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.

Primary Outcome

Review of adverse events including serious adverse events (SAEs), adverse events meeting protocol defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death

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
Akamis Bio

6 total trials

What the finished NCT02636036 record still lists

NCT02636036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower).

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.

NCT02636036 lists 6 locations in 5 states (California, Arizona, Indiana).

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.

What interventions are being tested in trial NCT02636036?

The interventions under investigation include: nivolumab (BIOLOGICAL), enadenotucirev (BIOLOGICAL).

Who is sponsoring clinical trial NCT02636036?

This trial is sponsored by Akamis Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Colorectal Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02636036's enrollment target sits among peer trials

51 269th of 381 higher than 111 of 381 other Colorectal Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02701153 · 51 participants · NA

    Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

  • NCT03663790 · 51 participants · NA

    Effects of Gait Retraining on Lower Extremity Biomechanics

  • NCT03874052 · 51 participants · Phase 1

    Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

  • NCT04704661 · 51 participants · Phase 1

    Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT02636036, the US trial registry maintained by the National Library of Medicine. NCT02636036 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.