A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab
NCT ID: NCT02124850
Last Updated: 2019-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
18 participants
INTERVENTIONAL
2014-10-28
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Motolimod plus cetuximab
Cohort 1: motolimod plus cetuximab
Motolimod
Cetuximab
Motolimod, cetuximab, and nivolumab
Cohort 2: motolimod, cetuximab, and nivolumab
Motolimod
Cetuximab
Nivolumab
Interventions
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Motolimod
Cetuximab
Nivolumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx
* Macroscopic complete resection of the primary tumor must be planned
* Age ≥ 18 years
* ECOG performance status 0-1
* Adequate hematologic, renal and hepatic function
* Have signed written informed consent
* Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors
* Prior severe infusion reaction to a monoclonal antibody
* Pregnancy or breastfeeding
* Evidence of distant metastasis
* Any other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, DCIS or LCIS of the breast
* Prior history of head and neck cancer
* Prior therapy with motolimod, nivolumab, or other agents targeting PD-1/PD-L1
* Prior therapy targeting the EGFR pathway
* Acute hepatitis, known HIV, or active uncontrolled infection
* Patients with active autoimmune disease
* History of uncontrolled cardiac disease within prior 6 months
* Uncontrolled peptic or gastric ulcer disease, or gastrointestinal bleeding within prior 6 months
* Active alcohol abuse or other illness or circumstance that carries a likelihood of inability to comply with study treatment and follow-up or otherwise compromise the study's objectives
* Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment
* Live vaccine within 30 days of planned start of study therapy
* History of pneumonitis or interstitial lung disease
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Amar Patel, MD
Role: STUDY_DIRECTOR
Celgene
Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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References
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https://clincancerres.aacrjournals.org/content/clincanres/early/2017/11/28/1078-0432.CCR-17-0357.full.pdf
Other Identifiers
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VRXP-A106
Identifier Type: -
Identifier Source: org_study_id
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