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A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Head and Neck Cancer
This is Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.
Study details:
This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ HNSCC. HNSCC patients should not have had previous systemic therapy administered in the recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if PD was ≥6 months after the last platinum-containing therapy dose. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed.
In the case of cetuximab, patients who have received cetuximab with radiotherapy as a local treatment and PD was \>1 year after the last dose of cetuximab are eligible.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-09-25
Primary completion: 2028-01-01
Study completion finish: 2030-07-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06525220
Intervention or treatment
DRUG: Petosemtamab
DRUG: Pembrolizumab
Conditions
- • Head and Neck Squamous Cell Carcinoma
Find a site
Closest Location:
Site 11
Research sites nearby
Select from list below to view details:
Site 11
Blacktown, New South Wales, 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: Petosemtamab + Pembrolizumab
| DRUG: Petosemtamab
|
ACTIVE_COMPARATOR: Pembrolizumab
| DRUG: Pembrolizumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR | Not Specified | Up to approximately 2 years |
Overall Survival (OS) | Not Specified | Up to approximately 3 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR | Not Specified | Up to approximately 2 years |
Duration of Response (DOR) per RECIST v1.1 as assessed by BICR | Not Specified | Up to approximately 2 years |
Incidence and Severity of AEs and SAEs | To evaluate safety and tolerability of petosemtamab in combination with pembrolizumab | Up to 30 days post-last dose |
Frequently Asked Questions
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