Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01468896 · ClinicalTrials.gov registry record · Phase 1
Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery
A Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 2
- Study locations
NCT01468896: Active Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT01468896 is a Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 23 participants, below the 126-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01468896, a Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of recombinant interleukin-12 when given together with cetuximab and to see how well they work in treating patients with squamous cell carcinoma of the head and neck that has come back, spread to another place in the body, or cannot be removed by surgery. Recombinant interleukin-12 may stimulate the white blood cells to kill tumor cells. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread Giving recombinant interleukin-12 together with cetuximab may kill more tumor cells.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Edodekin alfa
Study Locations (2)
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2011-10-26 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 1 |
What the registry record for NCT01468896 still lists
NCT01468896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 126-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cetuximab is the first listed.
NCT01468896 reports a single indexed study location in District of Columbia, Ohio.
Frequently Asked Questions
What is clinical trial NCT01468896 about?
NCT01468896 is a clinical study titled "Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery". This phase I/II trial studies the side effects and best dose of recombinant interleukin-12 when given together with cetuximab and to see how well they work in treating patients with squamous cell carcinoma of the head and neck that has come back, spread to another place in the body, or cannot be rem...
What is the current status of trial NCT01468896?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2011-10-26. Estimated completion is 2026-03-19.
What conditions does trial NCT01468896 study?
This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Unresectable Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT01468896?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Edodekin alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT01468896?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01468896 being conducted?
This trial has 2 study locations across District of Columbia, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Head-and-neck Squamous-cell Carcinoma
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 NCT01468896's enrollment target sits among peer trials
23 23rd of 24 higher than 1 of 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Head-and-neck Squamous-cell Carcinoma 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
-
STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers
RECRUITING · Phase 1
-
A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab
RECRUITING · Phase 1
-
(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma
RECRUITING · Phase 1
-
Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma
RECRUITING · Phase 1
-
TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer
RECRUITING · Phase 1
-
An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
ACTIVE NOT RECRUITING · Phase 1
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
- NCT03616041 · 23 participants
Capsule Endoscopy for Severe Hematochezia
- NCT04348747 · 23 participants · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
- NCT04587687 · 23 participants · Phase 2
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
- NCT04715022 · 23 participants · Phase 1
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
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