Clincosm LogoSign in Get a demo

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

Sponsor
Celgene (Industry)
Overall Status
Terminated
CT.gov ID
NCT02124850
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
24.1
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 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
Actual Study Start Date :
Oct 28, 2014
Actual Primary Completion Date :
Aug 11, 2016
Actual Study Completion Date :
Oct 31, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Motolimod plus cetuximab

Cohort 1: motolimod plus cetuximab

Drug: Motolimod
Other Names:
  • VTX-2337

    • Drug: Cetuximab
    Other Names:
  • Erbitux

    		•
    Experimental: Motolimod, cetuximab, and nivolumab

    Cohort 2: motolimod, cetuximab, and nivolumab

    Drug: Motolimod
    Other Names:
  • VTX-2337

    • Drug: Cetuximab
    Other Names:
  • Erbitux

    • Drug: Nivolumab
    Other Names:
  • Opdivo

    		•

    Outcome Measures

    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. [change from baseline to up to 4 weeks]

    Other Outcome Measures

    1. Anti-tumor response [Change from baseline to pre-surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232

    Sponsors and Collaborators

    • Celgene

    Investigators

    • Study Director: Amar Patel, MD, Celgene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT02124850
    Other Study ID Numbers:
    • VRXP-A106
    First Posted:
    Apr 28, 2014
    Last Update Posted:
    Oct 25, 2019
    Last Verified:
    Oct 1, 2019
    Additional relevant MeSH terms:
    Squamous Cell Carcinoma of Head and Neck
    Nivolumab
    Cetuximab

    Study Results

    No Results Posted as of Oct 25, 2019