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

PHASE3RECRUITING

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Study details:

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. HNSCC patients must have progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease, should have PD within 6 months of the last dose of platinum-containing therapy.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion 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)

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.

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).

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-06-25

Primary completion: 2028-02-01

Study completion finish: 2029-03-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06496178

Intervention or treatment

DRUG: Petosemtamab

DRUG: Investigator's Choice

Conditions

• Head and Neck Squamous Cell Carcinoma

Image related to Head and Neck Squamous Cell Carcinoma

Condition: Head and Neck Squamous Cell Carcinoma
DRUG: Petosemtamab and other drugs
Nedlands, Western Australia, Australia and more
Sponsor: Merus N.V.

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Find a site

Closest Location:

Site 30

Research sites nearby

Select from list below to view details:

Site 30
Nedlands, Western Australia, Australia
Site 3
Darlinghurst, Not Specified, Australia
Site 11
Saint Leonards, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: MCLA-158 Not Specified	DRUG: Petosemtamab MCLA-158
ACTIVE_COMPARATOR: Investigator's Choice Not Specified	DRUG: Investigator's Choice Cetuximab

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review	ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation.	Up to approximately 2 years
Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause.	Up to approximately 3 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review	PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause.	Up to approximately 2 years
Duration of Response (DOR) as Assessed by Blinded Independent Central Review	For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer.	Up to approximately 2 years
Objective Response Rate (ORR) as Assessed by Investigator Review	ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation.	Up to approximately 2 years
Progression Free Survival (PFS) as Assessed by Investigator Review	PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause.	Up to approximately 2 years
Duration of Response (DOR) as Assessed by Investigator Review	For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of the first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer.	Up to approximately 2 years
Time to Response (TTR) as Assessed by Blinded Independent Central Review	For participants with a confirmed CR or PR per RECIST v1.1, TTR was defined as the time from randomization to the first documented response per RECIST v1.1.	Up to approximately 2 years
Time to Response (TTR) as Assessed by Investigator Review	For participants with a confirmed CR or PR per RECIST v1.1, TTR was defined as the time from randomization to the first documented response per RECIST v1.1.	Up to approximately 2 years
Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review	CBR was defined as the proportion of participants with a confirmed CR or PR, or SD lasting 16 weeks for longer per RECIST v1.1	Up to approximately 2 years
Clinical Benefit Rate (CBR) as Assessed by Investigator Review	CBR was defined as the proportion of participants with a confirmed CR or PR, or SD lasting 16 weeks for longer per RECIST v1.1	Up to approximately 2 years
Number of participants Who experienced At Least One Treatment Emergent Adverse Event (TEAE)	An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who experienced at least one TEAE is presented.	Up to 30 days post-last dose
Number of participants Who experienced At Least One Serious TEAE	An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who experienced at least one serious TEAE is presented.	Up to 30 days post-last dose
Number of participants Who Discontinued Study Treatment Due to TEAEs	An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who discontinued study treatment due to TEAEs is presented.	Up to 30 days post-last dose
Number of participants Who Had Dose Modification Due to TEAEs	An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who had dose modification due to TEAEs is presented.	Up to 30 days post-last dose
Mean Change From Baseline in EORTC QLQ-C30	For the EORTC QLQ-C30, the functional scales, the symptom scales, the specific single items, and the global health and quality of life scale, will be computed according to EORTC QLQ-C30 Scoring Manual. Mean change from baseline is presented.	Up to approximately 2 years
Mean Change From Baseline in EORTC QLQ-H&N43	For the updated EORTC QLQ-H\&N43, the multi-item scales and the single-items will be computed according to EORTC QLW-HN43 Scoring Manual. Mean change from baseline is presented.	Up to approximately 2 years
Concentrations Predose And at End of Infusion	Predose and end of infusion plasma concentrations as measured from all individual plasma concentrations.	Up to first 6 cycles
Pharmacokinetic parameters	Clearance of plasma and central volume of distribution based on population PK model	Up to first 6 cycles
Incidence of anti-drug antibody (ADA)	The frequency and proportion of participants developing anti-drug antibodies.	Up to 30 days post-last dose

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References

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