A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma

NCT03254927 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CDX3379-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

Brief Summary

This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining CDX-3379 and cetuximab. The study will enroll patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed.

Conditions

Advanced Head and Neck Squamous Cell Carcinoma

Keywords

Erbitux; Cetuximab; Oral Cancer; Oropharyngeal cancer; Laryngeal cancer; Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The percentage of patients who achieve a complete response or partial response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1), Complete Response (CR) = disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.

  The proportion of evaluable patients who achieve a best overall response of complete or partial response according to RECIST 1.1 assessed up to 24 months.

Secondary Outcomes (6)

• Clinical Benefit Response (CBR)

  Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 2 years

• Duration of Response (DOR)

  First occurrence of a documented objective response to disease progression or death (up to approximately 2 years)

• Progression-free Survival (PFS)

  From first dose to the first occurrence of disease progression or death due to any cause (up to approximately 2 years)

• Overall Survival (OS)

  The time from start of study drug to death from any cause (up to approximately 2 years)

• Incidence of Adverse Events [Safety and Tolerability]

  Following at least one dose of study treatment through 30 days after last dose of CDX-3379.

Study Arms (1)

CDX-3379 and cetuximab

EXPERIMENTAL

During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression.

Drug: CDX-3379 and cetuximab

Interventions

CDX-3379 and cetuximab DRUG

Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.

CDX-3379 and cetuximab

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed head and neck squamous cell carcinoma.
• Human papilloma virus (HPV) negative tumor.
• Prior treatment with a check-point inhibitor targeting PD-1, unless not a candidate.
• Prior treatment with cetuximab with tumor progression during or within 6 months after completing treatment.
• Measurable disease.
• Life expectancy ≥ 12 weeks.
• If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 6 months following last treatment.
• Willingness to undergo a tumor biopsy prior to starting treatment (or if biopsy is not feasible, provide archival tissue).

You may not qualify if:

• Previous treatment with CDX-3379 or other anti-ErbB3 targeted agents.
• Nasal, paranasal sinus, or nasopharyngeal carcinoma, aside from WHO Type I and II (keratinizing, non-EBV positive) nasopharyngeal carcinoma which will be allowed.
• Major surgery within 4 weeks prior to first dose of study treatment.
• Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
• Monoclonal based therapies within 4 weeks (excluding cetuximab) and all other immunotherapy within 2 weeks prior to first dose of study treatment.
• Other prior malignancy, active within 3 years, except for localized prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin, stage 1 differentiated thyroid cancer or ductal carcinoma in situ of the breast.
• Active, untreated central nervous system metastases.
• Active autoimmune disease or documented history of autoimmune disease.
• Significant cardiovascular disease including CHF or poorly controlled hypertension.

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (10)

The University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Rush University Medical center

Chicago, Illinois, 60612, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University of Pennsylvania Hospital, Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Duvvuri U, George J, Kim S, Alvarado D, Neumeister VM, Chenna A, Gedrich R, Hawthorne T, LaVallee T, Grandis JR, Bauman JE. Molecular and Clinical Activity of CDX-3379, an Anti-ErbB3 Monoclonal Antibody, in Head and Neck Squamous Cell Carcinoma Patients. Clin Cancer Res. 2019 Oct 1;25(19):5752-5758. doi: 10.1158/1078-0432.CCR-18-3453. Epub 2019 Jul 15.

  PMID: 31308059 DERIVED

MeSH Terms

Conditions

Mouth Neoplasms; Oropharyngeal Neoplasms; Laryngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Study was terminated early due to unfavorable risk/benefit profile.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Celldex Therapeutics

info@celldex.com

844-723-9363

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 21, 2017
• Study Start: March 27, 2018
• Primary Completion: September 16, 2020
• Study Completion: December 16, 2020
• Last Updated: April 3, 2023
• Results First Posted: April 3, 2023

Record last verified: 2023-03

Locations

US (10)