Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
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.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically confirmed metastatic or recurrent HNSCC of the primary tumour location of oral cavity, oropharynx, hypopharynx, and larynx not amenable to locoregional treatment with curative intent. * Willingness to provide pretreatment (baseline) biopsy/tissue to the sponsor (fresh or archival one). A newly obtained biopsy is preferred but an archival sample is acceptable, with tumor tissue (formalin fixed paraffin embedded \[FFPE\] block preferred, or at least 10 freshly sectioned unstained FFPE slides) from a core or excisional biopsy. Any deviation from this rule requires approval by the sponsor. Details on the requirements for archival tumour tissue and on biopsy sample collection are provided in the Laboratory Manual. * Patients who have not received prior systemic treatment for metastatic or recurrent HNSCC. Systemic therapy (including cetuximab) which was completed more than 6 months prior to progression of disease if given as part of multimodal treatment for locally advanced disease is allowed. * Patients who do not have contraindications to pembrolizumab monotherapy according to pembrolizumab local label, guidelines, treatment standards, regulations or the document (label of another country if pembrolizumab local label is not available) provided in the investigator site file (ISF) by the sponsor. * Patients who do not have contraindications to treatment with cetuximab according to cetuximab local label, guidelines, treatment standards, regulations, or the document (label of another country if cetuximab local label is not available) provided in the ISF by the sponsor. * Presence of at least one measurable non-central nervous system (CNS) lesion (according to RECIST v1.1.). * Further inclusion criteria apply.
Exclusion criteria
* Nasopharyngeal carcinoma (NPC) of any histology, primary tumour location at nasal cavity, paranasal sinuses of any histology, any cancer of unknown primary. * Any tumour location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery, or radiation therapy), such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture. * Patients with progressive HNSCC within 6 months of completion of systemic therapy for locoregionally advanced disease with curative intent. * Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or endpoint assessment. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to trial entry, have discontinued corticosteroid treatment for these metastases and are clinically stable, off anticonvulsants for at least 4 weeks and are neurologically stable before enrollment. * Patients for whom single agent pembrolizumab is not the preferred treatment (e.g. patients for whom chemotherapy or anti-PD-1 in combination with chemotherapy is considered the preferred therapy by the investigator or treating physician). * Prior treatment with any anti signal regulatory protein alpha (SIRPα) or anti-integrin-associated protein (CD47) agent, regardless of treatment intent. * Prior cancer treatment with any anti PD-1 or anti PD-L1 agent or with an agent directed to another stimulatory or co-inhibitory Tcell receptor (e.g. CTLA-4, OX 40, CD137), regardless of treatment intent. * Prior allogeneic stem cell or solid organ transplantation. * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response (OR) with confirmation | Up to 27 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Up to 27 months | — |
| Overall survival (OS) | Up to 27 months | OS defined as the time from first treatment administration until death from any cause. |
| Overall survival at 6 and 12 months (OS6 and OS12) | At 6 months and 12 months | OS defined as being alive at 6 months or at 12 months from first treatment administration. |
| Progression-free survival (PFS) | Up to 27 months | 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. |
| Progression-free survival at 6 months (PFS6) | At 6 months | PFS defined as being alive and without progression at 6 months from first treatment administration. |
| Duration of objective response (DOR) | Up to 27 months | 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. |
Countries
Australia, Brazil, Bulgaria, France, Georgia, Germany, Hungary, Italy, Japan, Mexico, Moldova, Poland, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTBoehringer Ingelheim
Outcome results
None listed