Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients

Novartis

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Head and Neck Squamous Cell Carcinoma

Treatments

Biological: LJM716

Biological: cetuximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02143622

CLJM716X2104

Details and patient eligibility

About

To establish whether LJM716 in combination with cetuximab is safe and has beneficial effects in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

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. Other protocol-defined inclusion/exclusion criteria may apply