A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients
NCT Number: NCT06496178
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Head and Neck Squamous Cell Carcinoma
Interventions: DRUG: Petosemtamab|DRUG: Investigator's Choice|DRUG: Investigator's Choice|DRUG: Investigator's Choice
Sponsor: Merus N.V.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-25
Completion Date: 2029-03
Locations: Site 8, Louisville, Kentucky, 40202, United States|Site 5, Detroit, Michigan, 48201, United States|Site 7, Houston, Texas, 77030, United States|Site 4, Salt Lake City, Utah, 84112, United States|Site 6, Spokane, Washington, 99202, United States|Site 3, Darlinghurst, Australia|Site 1, Jerusalem, Israel|Site 2, Tel Aviv, Israel

Summary:
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.

Primary Outcome Measures: 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 Measures: 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