A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02124850
Recruitment Status : Unknown
Verified July 2016 by VentiRx Pharmaceuticals Inc..
Recruitment status was:  Recruiting
First Posted : April 28, 2014
Last Update Posted : July 22, 2016
Information provided by (Responsible Party):
VentiRx Pharmaceuticals Inc.

Brief Summary:
Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab, motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before surgery. The primary objective of the study is to determine the extent to which the administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and nivolumab modulates immune biomarkers (NK, mDC and T cell activation as well as tumor infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. An exploratory objective of the study is to assess whether modulation of biomarkers as described above can predict anti-tumor response.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: Motolimod Drug: Cetuximab Drug: Nivolumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Study of Neoadjuvant Immune Biomarker Modulation With Cetuximab Plus Motolimod and With Cetuximab Plus Motolimod Plus Nivolumab
Study Start Date : September 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Motolimod plus cetuximab
Cohort 1: motolimod plus cetuximab
Drug: Motolimod
Other Name: VTX-2337

Drug: Cetuximab
Other Name: Erbitux

Experimental: Motolimod, cetuximab, and nivolumab
Cohort 2: motolimod, cetuximab, and nivolumab
Drug: Motolimod
Other Name: VTX-2337

Drug: Cetuximab
Other Name: Erbitux

Drug: Nivolumab
Other Name: Opdivo

Primary Outcome Measures :
  1. The change in immune biomarkers including FcγR genotype, NK activation, tumor infiltration and serum cytokines, mDC, T cell activation, and tumor-antigen specific cytotoxic T lymphocyte induction. [ Time Frame: change from baseline to up to 4 weeks ]

Other Outcome Measures:
  1. Anti-tumor response [ Time Frame: Change from baseline to pre-surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously untreated stage II, III, or IVA histologically or cytologically confirmed squamous cell carcinoma of the head and neck
  • 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

Exclusion Criteria:

  • Subjects who fail to meet inclusion criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02124850

Contact: Yanyu Song (206) 973-1571

United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Carrie Muniz    412-623-6121   
Principal Investigator: Robert Ferris, MD, PhD         
Sponsors and Collaborators
VentiRx Pharmaceuticals Inc.
Principal Investigator: Robert Ferris, MD, PhD University of Pittsburgh

Responsible Party: VentiRx Pharmaceuticals Inc. Identifier: NCT02124850     History of Changes
Other Study ID Numbers: VRXP-A106
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs