A study to test whether treatment with BI 770371 in combination with pembrolizumab with or without cetuximab helps people with head and neck cancer compared with pembrolizumab alone

JRCT ID: jRCT2011240074

Registered date:05/03/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Head and Neck Squamous Cell Carcinoma
• Date of first enrollment: 30/04/2025
• Target sample size: 6
• Countries of recruitment: United States,Japan,Australia,Japan,Brazil,Japan,Bulgaria,Japan,France,Japan,Georgia,Japan,Germany,Japan,Hungary,Japan,Italy,Japan,Korea, Republic of,Japan,Mexico,Japan,Moldova, Republic of,Japan,Poland,Japan,Romania,Japan,Singapore,Japan,Spain,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

- Comparator: Pembrolizumab
Drug: Pembrolizumab

- Trial intervention: Pembrolizumab + BI 770371
Drug: BI 770371
Drug: Pembrolizumab

- Trial intervention: Pembrolizumab + BI 770371 + Cetuximab
Drug: BI 770371
Drug: Pembrolizumab
Drug: Cetuximab

Outcome(s)

Primary Outcome

- Objective response (OR) with confirmation [Time Frame: 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 Outcome

- Occurrence of treatment related adverse event (AE) from first treatment administration until the earliest of death, 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) leading to treatment discontinuation from first treatment administration until the earliest of death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent [Time Frame: Up to 27 months]
- Overall survival (OS) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: At 6 months]
PFS defined as being alive and without progression at 6 months from first treatment administration.
- Duration of objective response (DOR) [Time Frame: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 recent biopsy (<3 months) is preferred, however an archival biopsy up to 12 months prior to screening could be accepted. If these requirements cannot be met, then the patient may be allowed to enter the study at Sponsor discretion, after agreement between the Investigator and 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.

Exclude 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 (SIRPa) 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 exclusion criteria apply.

Related Information

• Primary Sponsor: Suzuki Yu
• Secondary ID(s): NCT06806852