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Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed by Surgery
NCT01696955 · View on ClinicalTrials.gov ↗
Study Summary
This randomized phase II trial studies how well cetuximab with or without tivantinib works in treating patients with head and neck cancer that has come back (recurrent), has spread to other places in the body (metastatic), or cannot be removed by surgery. Monoclonal antibodies, such as cetuximab, may interfere with the ability of tumor cells to grow and spread. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cetuximab is more effective with or without tivantinib in treating patients with head and neck cancer.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- OTHER Laboratory Biomarker Analysis
- DRUG Tivantinib
Study Locations (20)
Illinois
- Northwestern University — Chicago
- University of Chicago Comprehensive Cancer Center — Chicago
- Decatur Memorial Hospital — Decatur
- NorthShore University HealthSystem-Evanston Hospital — Evanston
- Ingalls Memorial Hospital — Harvey
- Illinois CancerCare-Peoria — Peoria
- Southern Illinois University School of Medicine — Springfield
California
- City of Hope Comprehensive Cancer Center — Duarte
- USC / Norris Comprehensive Cancer Center — Los Angeles
- University of California Davis Comprehensive Cancer Center — Sacramento
- City of Hope South Pasadena — South Pasadena
Indiana
- Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne
- Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis
Michigan
- University of Michigan Comprehensive Cancer Center — Ann Arbor
- Wayne State University/Karmanos Cancer Institute — Detroit
Minnesota
- Mayo Clinic — Rochester
- Metro Minnesota Community Oncology Research Consortium — Saint Louis Park
Arizona
- Mayo Clinic in Arizona — Scottsdale
Iowa
- University of Iowa/Holden Comprehensive Cancer Center — Iowa City
Maryland
- University of Maryland/Greenebaum Cancer Center — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2012-08-20 |
| Est. Completion | 2017-05-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01696955
The ClinicalTrials.gov registry entry for NCT01696955 describes a study currently listed as completed. It is categorized as Phase 2, 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 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Cetuximab 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: NCT01696955 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Illinois, California, 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 NCT01696955 about?
NCT01696955 is a clinical study titled "Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed by Surgery". This randomized phase II trial studies how well cetuximab with or without tivantinib works in treating patients with head and neck cancer that has come back (recurrent), has spread to other places in the body (metastatic), or cannot be removed by surgery. Monoclonal antibodies, such as cetuximab, ma...
What is the current status of trial NCT01696955?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2012-08-20. Estimated completion is 2017-05-05.
What conditions does trial NCT01696955 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01696955?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Tivantinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01696955?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01696955 being conducted?
This trial has 20 study locations across Arizona, California, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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