Trial Title:
A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT06064877
Condition:
Metastatic Head-and-neck Squamous-cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Recurrence
Cetuximab
Conditions: Keywords:
Recurrent
Metastatic
HPV-negative
Head and Neck
Squamous Cell Carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Double-Blind, Placebo-Controlled
Intervention:
Intervention type:
Biological
Intervention name:
Ficlatuzumab
Description:
Ficlatuzumab (AV-299) is a humanized hepatocyte growth factor (HGF) inhibitory
immunoglobulin G1 (IgG1) monoclonal antibody (mAb).
Arm group label:
Arm 1 (Investigational Arm: ficlatuzumab plus cetuximab)
Arm group label:
Arm 2 (Investigational Arm: ficlatuzumab plus cetuximab)
Other name:
AV-299
Intervention type:
Biological
Intervention name:
Cetuximab
Description:
Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.
Arm group label:
Arm 1 (Investigational Arm: ficlatuzumab plus cetuximab)
Arm group label:
Arm 2 (Investigational Arm: ficlatuzumab plus cetuximab)
Arm group label:
Arm 3 (Comparator Arm: placebo plus cetuximab)
Other name:
Erbitux
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo for this study will be normal saline
Arm group label:
Arm 3 (Comparator Arm: placebo plus cetuximab)
Summary:
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.
Detailed description:
This multicenter, randomized, double-blind, placebo-controlled Phase 3 study is designed
to compare the efficacy and safety of two dose levels of ficlatuzumab combined with
cetuximab (Arm 1 or Arm 2) to a control arm of placebo plus cetuximab (Arm 3) in
participants with R/M human papilloma virus (HPV)-negative HNSCC. Eligible participants
must have failed prior therapy with an anti-PD-1 [programmed cell death protein 1] or
PD-L1 [programmed death ligand 1] immune checkpoint inhibitor (ICI) and with
platinum-based chemotherapy, administered in combination or sequentially. Failure of
prior treatment may be due to progression of disease or intolerance to treatment. It is
anticipated that the study will enroll approximately 410 participants across 3 arms.
Criteria for eligibility:
Criteria:
Inclusion 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
Exclusion Criteria:
- 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
A full list of inclusion and exclusion criteria can be found in the protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85212
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Arizona Cancer Center
Address:
City:
Tucson
Zip:
85719
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale School of Medicine - Smilow Cancer Hospital
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Facility:
Name:
The George Washington University
Address:
City:
Washington
Zip:
20052-0042
Country:
United States
Status:
Recruiting
Facility:
Name:
AdventHealth Medical Group Oncology & Hematology at Orlando
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Facility:
Name:
Emory University
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Illinois Cancer Center
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Facility:
Name:
Mary Bird Perkins Cancer Center
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Maryland
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Siteman Cancer Center - Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwell Health Cancer Institute
Address:
City:
Lake Success
Zip:
10042
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Cincinnati - UC Health Barrett Cancer Center
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Facility:
Name:
Ohio State University, James Cancer Hospital and Solove Research Institute
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pittsburgh Medical Center - Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Facility:
Name:
Medical University of South Carolina (MUSC)
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Consultants
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
VCU Massey Cancer Center
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Facility:
Name:
Medical College of Wisconsin - Froedtert Hospital Cancer Center
Address:
City:
Milwaukee
Zip:
53202
Country:
United States
Status:
Recruiting
Facility:
Name:
St George Hospital
Address:
City:
Kogarah
Zip:
2217
Country:
Australia
Status:
Recruiting
Facility:
Name:
St. Vincent's Hospital
Address:
City:
Sydney
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Brisbane
Zip:
4102
Country:
Australia
Status:
Recruiting
Facility:
Name:
St. John of God Murdoch Hospital
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Status:
Recruiting
Facility:
Name:
Tom Baker Cancer Centre (Alberta Health Services)
Address:
City:
Calgary
Zip:
T3N 4N1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Facility:
Name:
The Ottawa Hospital Cancer Centre
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Center - University Health Network
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
McGill University Health Centre (MUHC)
Address:
City:
Montréal
Zip:
H4A3J1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Keimyung University Dongsan Hospital
Address:
City:
Daegu
Zip:
42601
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Address:
City:
Seoul
Zip:
03312
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Ajou University Hospital
Address:
City:
Suwon
Zip:
16499
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Changhua Christian Hospital
Address:
City:
Changhua
Zip:
500
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Memorial Hospital - Kaohsiung
Address:
City:
Kaohsiung
Zip:
833401
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
China Medical University Hospital (CMUH)
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Cheng-Kung University Hospital
Address:
City:
Tainan
Zip:
704017
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
112201
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Memorial Hospital - Linkou
Address:
City:
Taoyuan
Zip:
33305
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
NHS Grampian - Aberdeen Royal Infirmary
Address:
City:
Aberdeen
Zip:
AB25 2ZN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
London
Zip:
W1G 6AD
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
City Hospital Nottingham
Address:
City:
Nottingham
Zip:
NG5 1PB
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Royal Marden Hospital, Surrey
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Torbay Hospital
Address:
City:
Torquay
Zip:
TQ2 7AA
Country:
United Kingdom
Status:
Recruiting
Start date:
January 11, 2024
Completion date:
November 2027
Lead sponsor:
Agency:
AVEO Pharmaceuticals, Inc.
Agency class:
Industry
Source:
AVEO Pharmaceuticals, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06064877
