RECRUITING

A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma

Conditions

Metastatic Head-and-neck Squamous-cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma Recurrent Metastatic HPV-negative Head and Neck Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and/or overall survival.

Official Title

A Multicenter, Randomized, Double Blind, Placebo - Controlled, Phase 3 Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV -Negative Head and Neck Squamous Cell Carcinoma. (FIERCE-HN)

Quick Facts

Study Start:2024-01-11

Study Completion:2027-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06064877

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female and ≥ 18 years of age * Histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC * Participants with oropharyngeal cancer will be required to be p16 negative and have proof of HPV-negative status submitted on the basis of a pathology report * At least 1 measurable lesion by contrast CT or MRI scan according to RECIST v.1.1. Such lesions must not have been previously irradiated; if the measurable lesion(s) has been irradiated, clear progression must be documented * Participants must have failed prior therapy with an anti-PD-1/PD-L1 ICI and with platinum-based chemotherapy administered in combination or sequentially, in either the locally advanced or R/M setting. Failure of prior treatment may be due to progression of disease or intolerance to treatment * Patient's tumor must be considered inoperable and incurable * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life expectancy of at least 12 weeks * For women of childbearing potential (WOCBP), documentation of negative serum pregnancy test within 30 days of randomization * For WOCBP and male participants whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least 60 days after the last dose of study treatment. Birth control methods which may be considered highly effective include methods that achieve a failure rate of less than 1% per year when used consistently and correctly. * Ability to give written informed consent and comply with protocol requirements * Patients with feeding tubes are eligible for the study. * Archived tissue sample must be submitted to the Sponsor-designated laboratory within 60 days of randomization for c-Met/HGF analysis	* History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cetuximab * Known or suspected untreated and uncontrolled brain metastases or leptomeningeal carcinomatosis Note: Participants with locally treated brain metastases are eligible provided 2 weeks have elapsed since local therapy. Participants are allowed to continue steroid taper during the start of study treatment. * Prior treatment with any other investigational drug or biologic agent or radiation therapy before a washout has been completed (must be completed prior to randomization): 1. 2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors 2. 3 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates 3. 4 weeks (28 days) for cell therapies 4. 2 weeks (14 days) for radiation therapy * Any unresolved and significant toxicity (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) Grade \> 2 from previous anticancer therapy (including radiation therapy), other than alopecia * Significant cardiovascular disease, including: Cardiac failure New York Heart Association class III or IV; Myocardial infarction, severe or unstable angina within 6 months prior to randomization; History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) * Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the participant's involvement in the study or interfere with the interpretation of study results * History of prior malignancy within 2 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early-stage prostate cancer, without evidence of recurrence; participants may or may not be on maintenance therapy) * Female participants who are pregnant or breastfeeding

Inclusion Criteria

Exclusion Criteria

* Male or female and ≥ 18 years of age
* Histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC
* Participants with oropharyngeal cancer will be required to be p16 negative and have proof of HPV-negative status submitted on the basis of a pathology report
* At least 1 measurable lesion by contrast CT or MRI scan according to RECIST v.1.1. Such lesions must not have been previously irradiated; if the measurable lesion(s) has been irradiated, clear progression must be documented
* Participants must have failed prior therapy with an anti-PD-1/PD-L1 ICI and with platinum-based chemotherapy administered in combination or sequentially, in either the locally advanced or R/M setting. Failure of prior treatment may be due to progression of disease or intolerance to treatment
* Patient's tumor must be considered inoperable and incurable
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life expectancy of at least 12 weeks
* For women of childbearing potential (WOCBP), documentation of negative serum pregnancy test within 30 days of randomization
* For WOCBP and male participants whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least 60 days after the last dose of study treatment. Birth control methods which may be considered highly effective include methods that achieve a failure rate of less than 1% per year when used consistently and correctly.
* Ability to give written informed consent and comply with protocol requirements
* Patients with feeding tubes are eligible for the study.
* Archived tissue sample must be submitted to the Sponsor-designated laboratory within 60 days of randomization for c-Met/HGF analysis

* History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cetuximab
* Known or suspected untreated and uncontrolled brain metastases or leptomeningeal carcinomatosis Note: Participants with locally treated brain metastases are eligible provided 2 weeks have elapsed since local therapy. Participants are allowed to continue steroid taper during the start of study treatment.
* Prior treatment with any other investigational drug or biologic agent or radiation therapy before a washout has been completed (must be completed prior to randomization):
1. 2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors
2. 3 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates
3. 4 weeks (28 days) for cell therapies
4. 2 weeks (14 days) for radiation therapy
* Any unresolved and significant toxicity (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) Grade \> 2 from previous anticancer therapy (including radiation therapy), other than alopecia
* Significant cardiovascular disease, including: Cardiac failure New York Heart Association class III or IV; Myocardial infarction, severe or unstable angina within 6 months prior to randomization; History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
* Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the participant's involvement in the study or interfere with the interpretation of study results
* History of prior malignancy within 2 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early-stage prostate cancer, without evidence of recurrence; participants may or may not be on maintenance therapy)
* Female participants who are pregnant or breastfeeding

Contacts and Locations

Study Contact

Clinical Trials Office

CONTACT

+1.857.400.0101

clinical@aveooncology.com

Study Locations (Sites)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85212

United States

The University of Arizona Cancer Center

Tucson, Arizona, 85719

United States

Yale School of Medicine - Smilow Cancer Hospital

New Haven, Connecticut, 06511

United States

The George Washington University

Washington, District of Columbia, 20052-0042

United States

AdventHealth Medical Group Oncology & Hematology at Orlando

Orlando, Florida, 32804

United States

Emory University

Atlanta, Georgia, 30308

United States

University of Illinois Cancer Center

Chicago, Illinois, 60612

United States

University of Kansas Cancer Center

Westwood, Kansas, 66205

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809

United States

University of Maryland

Baltimore, Maryland, 21201

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Siteman Cancer Center - Washington University

Saint Louis, Missouri, 63110

United States

Montefiore Medical Center

Bronx, New York, 10461

United States

Northwell Health Cancer Institute

Lake Success, New York, 10042

United States

University of Cincinnati - UC Health Barrett Cancer Center

Cincinnati, Ohio, 45219

United States

Ohio State University, James Cancer Hospital and Solove Research Institute

Columbus, Ohio, 43210

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

University of Pittsburgh Medical Center - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Oncology Consultants

Houston, Texas, 77030

United States

VCU Massey Cancer Center

Richmond, Virginia, 23298

United States

Medical College of Wisconsin - Froedtert Hospital Cancer Center

Milwaukee, Wisconsin, 53202

United States

Collaborators and Investigators

Sponsor: AVEO Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-11

Study Completion Date2027-11

Study Record Updates

Study Start Date2024-01-11

Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

Recurrent
Metastatic
HPV-negative
Head and Neck
Squamous Cell Carcinoma

Additional Relevant MeSH Terms

Metastatic Head-and-neck Squamous-cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma