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

NCT02124850 | Terminated Phase 1 DMC

• 1 other identifier: VRXP-A106
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Anti-tumor response

  Change from baseline to pre-surgery

Study Arms (2)

Motolimod plus cetuximab

EXPERIMENTAL

Cohort 1: motolimod plus cetuximab

Drug: Motolimod; Drug: Cetuximab

Motolimod, cetuximab, and nivolumab

EXPERIMENTAL

Cohort 2: motolimod, cetuximab, and nivolumab

Drug: Motolimod; Drug: Cetuximab; Drug: Nivolumab

Interventions

Motolimod DRUG

Also known as: VTX-2337

Motolimod plus cetuximab; Motolimod, cetuximab, and nivolumab

Cetuximab DRUG

Also known as: Erbitux

Motolimod plus cetuximab; Motolimod, cetuximab, and nivolumab

Nivolumab DRUG

Also known as: Opdivo

Motolimod, cetuximab, and nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• https://clincancerres.aacrjournals.org/content/clincanres/early/2017/11/28/1078-0432.CCR-17-0357.full.pdf

  RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

VTX-2337; Cetuximab; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Amar Patel, MD

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 28, 2014
• Study Start: October 28, 2014
• Primary Completion: August 11, 2016
• Study Completion: October 31, 2016
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

US (1)