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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Ficerafusp alfa
DrugBifunctional antibody and recombinant fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol.
Pembrolizumab
DrugMonoclonal antibody, single-dose vial, via intravenous infusion per protocol.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Ficerafusp Alfa plus PembrolizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Pathologic Treatment Response-2 (pTR-2) Rate
pTR-2 rate is defined as ≥50% pathological response of the primary tumor using the surgical specimen following neoadjuvant therapy as established by 2 independent pathologists.
Time frame
Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment.Secondary outcomes
1
Median Event-free survival (EFS)
EFS is defined as the time from date of surgery to first invasive local, regional, distant recurrence, or death due to any cause. Participants alive without disease are censored at date of last disease evaluation. Median EFS is estimated based on the Kaplan-Meier method. Disease recurrence is established by 2 independent pathologists.
Time frame
Disease assessed every 3 months up to 24 months from date of surgery (+42 days from start of neoadjuvant therapy).2
Median Overall Survival
OS is defined as the time from study registration until death due to any cause, or censored at the date last known alive. Median OS is estimated based on the Kaplan-Meier method.
Time frame
Survival assessed every 3 months up to 24 months from date of surgery (+42 days from start of neoadjuvant therapy).3
Pathologic Response Rate by PD-LI Combined positive score (CPS) Subgroup
Pathologic response rate is defined as ≥50% pathological response of the primary tumor using the surgical specimen following neoadjuvant therapy as established by 2 independent pathologists. PD-LI expression will be evaluated per established methods and PD-LI CPS ranges from 0-100.
Time frame
Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment.4
Major Pathologic Response Rate
MPR rate is defined as the percentage of participants with ≥90% pathological response of the primary tumor and lymph nodes using the surgical specimen following neoadjuvant therapy as established by 2 independent pathologists.
Time frame
Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
Bicara Therapeutics
Collaborator
Source ClinicalTrials.gov