Health TrialsbyHealthPanel

A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

ConditionHead and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerus B.V.

About this trial

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+ head and neck squamous cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed ICF before initiation of any study procedures

Age ≥ 18 years at signing of ICF

Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.

The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.

Disqualifiers

Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days prior to randomization

Known leptomeningeal involvement

Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization

Requirement for immunosuppressive medication

Trial design

Design model

Parallel

Treatments tested in this trial

  • Petosemtamab

    Drug

    MCLA-158

  • Pembrolizumab

    Drug

    Humanized Antibody

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: Petosemtamab + PembrolizumabExperimental treatment 2 interventions
Group B: PembrolizumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time frame
Up to approximately 3 years
2

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR)

Time frame
Up to approximately 2 years

Secondary outcomes

1

Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR

Time frame
Up to approximately 2 years
2

Duration of Response (DOR) per RECIST v1.1 as assessed by BICR

Time frame
Up to approximately 2 years
3

Clinical benefit rate per RECIST v1.1 as assessed by BICR

Time frame
Up to approximately 2 years
4

Time to response (TTR) per RECIST v1.1 as assessed by BICR

Time frame
Time Frame: Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merus B.V.

Lead sponsor

Source ClinicalTrials.gov
Apply now