Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC).
The names of the study drugs used in this research study are:
* ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein) * pembrolizumab (a type of monoclonal antibody)
Eligibility criteria
Qualifiers
Participants must have histologically or cytologically confirmed, untreated and newly diagnosed, locoregionally advanced head and neck squamous cell carcinoma (HNSCC) arising from oral cavity, oropharynx (with documented HPV-negative disease if presenting with oropharyngeal SCC), larynx, or hypopharynx.
Participants should have resectable disease at baseline per the discretion of the treating surgical oncologist.
T1-2, N1-3: III
T3, any N: III, IVA, IVB
Disqualifiers
Recurrent or metastatic (M1 or IVC disease by AJCC 2017 8th edition staging) HNSCC or very early-stage HNSCC (stage I or II by AJCC 2017 8th edition staging); or head and neck cancer arising at other primary subsites such as the skin, paranasal sinuses, nasal cavity, or salivary glands.
HPV-associated oropharyngeal cancer (as determined by p16 positivity by immunohistochemistry and/or confirmatory HPV RNA ISH or PCR testing, or by plasma HPV DNA testing results).
Inoperable or surgically unresectable at baseline per the treating investigator(s).
ECOG performance status of 2 or greater.
Trial design
Treatments tested in this trial
- Ficerafusp alfa
- Pembrolizumab
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Dana-Farber Cancer Institute
Lead sponsor
Bicara Therapeutics
Collaborator
Source ClinicalTrials.gov