RECRUITING

A Phase 3 Study to Evaluate Petosemtamab Compared with Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared with Investigator's Choice Monotherapy Treatment in Previously Treated Patients with Incurable, Metastatic/recurrent Head and Neck Squamous Cell Carcinoma

Quick Facts

Study Start:2024-06-25

Study Completion:2029-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06496178

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Signed ICF before initiation of any study procedures. * 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. * 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. * 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. * Measurable disease as defined by RECIST v1.1 by radiologic methods. * ECOG PS of 0 or 1 * Life expectancy ≥ 12 weeks, as per investigator * Adequate organ function (as per protocol)	* 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 * 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. * 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. * 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 * 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 * Patients with known infectious diseases (as per protocol) * Pregnant or breastfeeding patients * Patient has a primary tumor site of nasopharynx (any histology).

Inclusion Criteria

Exclusion Criteria

* Signed ICF before initiation of any study procedures.
* 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.
* 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.
* 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.
* Measurable disease as defined by RECIST v1.1 by radiologic methods.
* ECOG PS of 0 or 1
* Life expectancy ≥ 12 weeks, as per investigator
* Adequate organ function (as per protocol)

* 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
* 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.
* 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.
* 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
* 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
* Patients with known infectious diseases (as per protocol)
* Pregnant or breastfeeding patients
* Patient has a primary tumor site of nasopharynx (any histology).

Contacts and Locations

Study Contact

David Yao, MD

CONTACT

+1 617 401 4499

USenquiries@merus.nl

Eduardo Pennella, MD

CONTACT

+1 617 401 4499

USenquiries@merus.nl

Study Locations (Sites)

Site 25

La Jolla, California, 92093

United States

Site 28

Palo Alto, California, 94304

United States

Site 12

Bradenton, Florida, 34205

United States

Site 9

Orlando, Florida, 32827

United States

Site 31

Indianapolis, Indiana, 46202

United States

Site 8

Louisville, Kentucky, 40202

United States

Site 5

Detroit, Michigan, 48201

United States

Site 18

Saint Louis, Missouri, 63110

United States

Site 15

Albuquerque, New Mexico, 87131

United States

Site 24

New York, New York, 10029

United States

Site 23

Cincinnati, Ohio, 45219

United States

Site 32

Columbus, Ohio, 43210

United States

Site 26

Portland, Oregon, 97213

United States

Site 34

El Paso, Texas, 79915

United States

Site 7

Houston, Texas, 77030

United States

Site 4

Salt Lake City, Utah, 84112

United States

Site 10

Blacksburg, Virginia, 24060

United States

Site 22

Charlottesville, Virginia, 22908

United States

Site 6

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: Merus N.V.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-25

Study Completion Date2029-03

Study Record Updates

Study Start Date2024-06-25

Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

HNSCC

Additional Relevant MeSH Terms

Head and Neck Squamous Cell Carcinoma