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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Celgene
Study ID
NCT02124850
Phase
PHASE1
Status
Terminated

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Motolimod — DRUG
  • Cetuximab — DRUG
  • Nivolumab — DRUG

Study Details

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.

Key Dates

Start date
Oct 28, 2014
Status verified
Oct 2019
Primary completion
Aug 11, 2016
Completion
Oct 31, 2016

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Motolimod plus cetuximab
    Cohort 1: motolimod plus cetuximab
  • Experimental: Motolimod, cetuximab, and nivolumab
    Cohort 2: motolimod, cetuximab, and nivolumab

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-

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By research site
University of Pittsburgh Medical Center· Pittsburgh, PA

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