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Trial record 2 of 6 for:    ventirx

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by VentiRx Pharmaceuticals Inc.
Sponsor:
Information provided by (Responsible Party):
VentiRx Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT02124850
First received: April 22, 2014
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Squamous Cell Carcinoma of the Head and Neck
Drug: Motolimod
Drug: Cetuximab
Drug: Nivolumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by VentiRx Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Anti-tumor response [ Time Frame: Change from baseline to pre-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02124850

Contacts
Contact: Yanyu Song (206) 973-1571 ysong@ventirx.com

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

Responsible Party: VentiRx Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02124850     History of Changes
Other Study ID Numbers: VRXP-A106 
Study First Received: April 22, 2014
Last Updated: July 20, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 09, 2016