A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients
A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients
This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
Head/Neck
Phase III
Adults
Not Available
Not Available
Choe, Jennifer
International
Vanderbilt University
02-21-2025
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Signed ICF before initiation of any study procedures.
Signed ICF before initiation of any study procedures.
Age 18 years at signing of ICF.
Age 18 years at signing of ICF.
Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
HNSCC patients progressed on or after anti-PD-1 therapy and platinum-containing therapy.
HNSCC patients progressed on or after anti-PD-1 therapy and platinum-containing therapy.
The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
Documentation of p16 status (positive or negative) by local laboratory IHC for patients with primary oropharyngeal cancer.
Documentation of p16 status (positive or negative) by local laboratory IHC for patients with primary oropharyngeal cancer.
A baseline new tumor sample unless the patient has an available tumor sample as an FFPE block with sufficient material.
A baseline new tumor sample unless the patient has an available tumor sample as an FFPE block with sufficient material.
Measurable disease as defined by RECIST v1.1 by radiologic methods.
Measurable disease as defined by RECIST v1.1 by radiologic methods.
ECOG PS of 0 or 1
ECOG PS of 0 or 1
Life expectancy 12 weeks, as per investigator
Life expectancy 12 weeks, as per investigator
Adequate organ function (as per protocol)
Adequate organ function (as per protocol)
Exclusion Criteria:
Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.
Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.
Known leptomeningeal involvement
Known leptomeningeal involvement
Any systemic anticancer therapy within 4 weeks of the first dose of study treatment.
Any systemic anticancer therapy within 4 weeks of the first dose of study treatment.
Major surgery or radiotherapy within 3 weeks of the first dose of study treatment.
Major surgery or radiotherapy within 3 weeks of the first dose of study treatment.
Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
History of hypersensitivity reaction to any of the excipients of treatment required for this study.
History of hypersensitivity reaction to any of the excipients of treatment required for this study.
Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry
Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry
History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease
History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease
Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
Patients with known infectious diseases (as per protocol)
Patients with known infectious diseases (as per protocol)
Pregnant or breastfeeding patients
Pregnant or breastfeeding patients
Patient has a primary tumor site of nasopharynx (any histology).
Patient has a primary tumor site of nasopharynx (any histology).
Signed ICF before initiation of any study procedures.
Signed ICF before initiation of any study procedures.
Age 18 years at signing of ICF.
Age 18 years at signing of ICF.
Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
HNSCC patients progressed on or after anti-PD-1 therapy and platinum-containing therapy.
HNSCC patients progressed on or after anti-PD-1 therapy and platinum-containing therapy.
The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
Documentation of p16 status (positive or negative) by local laboratory IHC for patients with primary oropharyngeal cancer.
Documentation of p16 status (positive or negative) by local laboratory IHC for patients with primary oropharyngeal cancer.
A baseline new tumor sample unless the patient has an available tumor sample as an FFPE block with sufficient material.
A baseline new tumor sample unless the patient has an available tumor sample as an FFPE block with sufficient material.
Measurable disease as defined by RECIST v1.1 by radiologic methods.
Measurable disease as defined by RECIST v1.1 by radiologic methods.
ECOG PS of 0 or 1
ECOG PS of 0 or 1
Life expectancy 12 weeks, as per investigator
Life expectancy 12 weeks, as per investigator
Adequate organ function (as per protocol)
Adequate organ function (as per protocol)
Exclusion Criteria:
Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.
Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.
Known leptomeningeal involvement
Known leptomeningeal involvement
Any systemic anticancer therapy within 4 weeks of the first dose of study treatment.
Any systemic anticancer therapy within 4 weeks of the first dose of study treatment.
Major surgery or radiotherapy within 3 weeks of the first dose of study treatment.
Major surgery or radiotherapy within 3 weeks of the first dose of study treatment.
Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
History of hypersensitivity reaction to any of the excipients of treatment required for this study.
History of hypersensitivity reaction to any of the excipients of treatment required for this study.
Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry
Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry
History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease
History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease
Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
Patients with known infectious diseases (as per protocol)
Patients with known infectious diseases (as per protocol)
Pregnant or breastfeeding patients
Pregnant or breastfeeding patients
Patient has a primary tumor site of nasopharynx (any histology).
Patient has a primary tumor site of nasopharynx (any histology).
