A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients
PHASE3ACTIVE_NOT_RECRUITING
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.
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.
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).
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06496178
Intervention or treatment
DRUG: Petosemtamab
DRUG: Investigator's Choice
DRUG: Investigator's Choice
DRUG: Investigator's Choice
Conditions
- Head and Neck Squamous Cell Carcinoma
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Research sites nearby
Closest Location:
Site 3
Select from list below to view details:
Site 3
Darlinghurst, Australia
Site 170
Herston, Australia
Site 38
Melbourne, Australia
Site 30
Nedlands, Australia
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Who is running the clinical trial?
MN
Merus N.V.
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
| Drug: Petosemtamab |
ACTIVE_COMPARATOR: Investigator's Choice
| Drug: Investigator's Choice |
What is the study measuring?
Primary Outcome
| Measure | Description | 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
| Measure | Description | 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 PatientsOther trials to consider
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