Informations générales (source: ClinicalTrials.gov)
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) (FIERCE-HN)
Interventional
Phase 3
AVEO Pharmaceuticals, Inc. (Voir sur ClinicalTrials)
janvier 2024
novembre 2027
19 décembre 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Assistance Publique Hopitaux de Marseille (APHM)-Hôpital La Timone - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Clinique Pasteur - Lanroze- Centre Finistérien de Radiothérapie et d'Oncologie - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Hôpital Privé des Côtes d'Armor - 22190 - Plérin - France | Contact (sur clinicalTrials) | ||||
| Pôle Santé Léonard de Vinci - 37170 - Chambray-lès-Tours - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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 5 months 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
- 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 5 months 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
A full list of inclusion and exclusion criteria can be found in the protocol.