A study to investigate whether LJM716 in combination with cetuximab is safe and has beneficial effects in patients with advanced head and neck cancer who progressed on prior therapy

A phase Ib/II, multicenter study of LJM716 in combination with cetuximab in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005540-28-IT

Enrollment

128

Registered

2014-05-09

Start date

2014-06-11

Completion date

Unknown

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck squamous cell carcinoma MedDRA version: 17.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: ND Product Code: LJM716 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ND CAS Number: ND Current Sponsor code: LJM716 Other descriptive name: ND Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Maximum of 1 prior therapy for recurrent or metastatic disease (Phase II) ? Most recent regimen contains both platinum and cetuximab (Phase II, group B). ? ECOG Performance Status (PS) = 2. ? Recovery from all AEs of previous anti-cancer therapies, to baseline or to CTCAE Grade = 1, except for alopecia. ? Measurable disease as determined by RECIST v1.1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64

Exclusion criteria

Exclusion criteria: ? Previous anti-HER3 antibody treatment. ? Symptomatic brain metastasis. ? Prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment. ? Prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations. ? Inadequate end organ function. ? Ongoing diarrhea CTCAE Grade = 2.

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase Ib: To determine RP2D and estimate MTD of LJM716 in combination with cetuximab in patients with RM HNSCC Phase II: To access the anti-tumor activity of LJM716-cetuximab combination in cetuximab naïve (Group A) and cetuximab pretreated (Group B) patients with RM HNSCC;Secondary Objective: To further characterize the safety and tolerability of the combination To characterize the PK profiles of LJM716 and describe cetuximab concentration when used in combination To further assess the anti-tumor activity of LJM716 when administered in combination with cetuximab ;Primary end point(s): Phase Ib 1) Change from baseline of target lesions per RECIST 1.1 2) Incidence of DLTs Phase II 1) Overall response rate (ORR) per RECIST 1.1;Timepoint(s) of evaluation of this end point: Phase Ib 1) 6 months 2) 35 days Phase II 1) 6 months	—

Measure

Time frame

Main Objective: Phase Ib: To determine RP2D and estimate MTD of LJM716 in combination with cetuximab in patients with RM HNSCC Phase II: To access the anti-tumor activity of LJM716-cetuximab combination in cetuximab naïve (Group A) and cetuximab pretreated (Group B) patients with RM HNSCC;Secondary Objective: To further characterize the safety and tolerability of the combination To characterize the PK profiles of LJM716 and describe cetuximab concentration when used in combination To further assess the anti-tumor activity of LJM716 when administered in combination with cetuximab ;Primary end point(s): Phase Ib 1) Change from baseline of target lesions per RECIST 1.1 2) Incidence of DLTs Phase II 1) Overall response rate (ORR) per RECIST 1.1;Timepoint(s) of evaluation of this end point: Phase Ib 1) 6 months 2) 35 days Phase II 1) 6 months

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Secondary

Measure	Time frame
Secondary end point(s): Phase Ib and II 1) Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity. 2) Plasma concentration versus time profiles, plasma PK parameters of LJM716; concentration of cetuximab 3) Best overall response (BOR), duration of response (DOR), overall survival (OS) and PFS per RECIST 1.1;Timepoint(s) of evaluation of this end point: Phase Ib and II 1) 6 months 2) 6 months 3) 6 months for BOR, DOR, PFS; 12 months for OS	—

Measure

Time frame

Secondary end point(s): Phase Ib and II 1) Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity. 2) Plasma concentration versus time profiles, plasma PK parameters of LJM716; concentration of cetuximab 3) Best overall response (BOR), duration of response (DOR), overall survival (OS) and PFS per RECIST 1.1;Timepoint(s) of evaluation of this end point: Phase Ib and II 1) 6 months 2) 6 months 3) 6 months for BOR, DOR, PFS; 12 months for OS

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Countries

Canada, Germany, Italy, Netherlands, Singapore, Spain, Switzerland, United States

Contacts

Public ContactDrug Regulatory Affairs

NOVARTIS FARMA

info.studiclinici@novartis.com+390296541

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026