This study is open to adults with head and neck cancer. The purpose of this study is to find out whether combining different study medicines makes tumors shrink in people with head and neck cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing. Participants are put into 3 groups randomly. Each group receives a different combination of study medicines. All study medicines are given as an infusion into a vein at the study site. Participants can stay in the study as long as they benefit from treatment. Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
BI 770371
Pembrolizumab
Cetuximab
Norton Cancer Institute, Downtown
Louisville, Kentucky, United States
M Health Fairview Clinics and Surgery Center - Minneapolis
Minneapolis, Minnesota, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Gosford Hospital
Gosford, New South Wales, Australia
Andrew Love Cancer Centre
Geelong, Victoria, Australia
Objective response (OR) with confirmation
OR defined as the best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to response evaluation criteria in solid tumours version 1.1 (RECIST v1.1). Objective response (OR) will be defined by investigator's assessment from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent.
Time frame: Up to 27 months
Occurrence of treatment related adverse event (AE) from first treatment administration until the earliest of 90 days after the last dose, death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent
Time frame: Up to 27 months
Occurrence of treatment related AE leading to treatment discontinuation from first treatment administration until the earliest of 90 days after the last dose, death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent
Time frame: Up to 27 months
Overall survival (OS)
OS defined as the time from first treatment administration until death from any cause.
Time frame: Up to 27 months
Overall survival at 6 and 12 months (OS6 and OS12)
OS defined as being alive at 6 months or at 12 months from first treatment administration.
Time frame: At 6 months and 12 months
Progression-free survival (PFS)
PFS defined as the time from first treatment administration until disease progression (PD) according to RECIST v1.1 or death from any cause, whichever occurs earlier.
Time frame: Up to 27 months
Progression-free survival at 6 months (PFS6)
PFS defined as being alive and without progression at 6 months from first treatment administration.
Time frame: At 6 months
Duration of objective response (DOR)
DOR defined as the time from first documented CR or PR (RECIST v1.1) until the earliest of PD or death among patients with OR.
Time frame: Up to 27 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital de Amor
Barretos, Brazil
Liga Norte Riograndense contra o cancer
Natal, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, Brazil
MBAL Sveta Sofia
Sofia, Bulgaria
CTR Oscar Lambret
Lille, France
...and 41 more locations