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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06806852




Registration number
NCT06806852
Ethics application status
Date submitted
28/01/2025
Date registered
4/02/2025

Titles & IDs
Public title
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
Scientific title
A Phase Ib Open Label Randomised Clinical Trial to Evaluate Safety and Efficacy of BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Compared With Pembrolizumab Monotherapy for the First-line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)
Secondary ID [1] 0 0
2024-517091-38-00
Secondary ID [2] 0 0
1501-0002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 770371
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Cetuximab

Experimental: Pembrolizumab -

Experimental: Pembrolizumab + BI 770371 -

Experimental: Pembrolizumab + BI 770371 + Cetuximab -


Treatment: Drugs: BI 770371
BI 770371

Treatment: Drugs: Pembrolizumab
Pembrolizumab

Treatment: Drugs: Cetuximab
Cetuximab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response (OR) with confirmation
Timepoint [1] 0 0
Up to 27 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 27 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 27 months
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
Up to 27 months
Secondary outcome [4] 0 0
Overall survival at 6 and 12 months (OS6 and OS12)
Timepoint [4] 0 0
At 6 months and 12 months
Secondary outcome [5] 0 0
Progression-free survival (PFS)
Timepoint [5] 0 0
Up to 27 months
Secondary outcome [6] 0 0
Progression-free survival at 6 months (PFS6)
Timepoint [6] 0 0
At 6 months
Secondary outcome [7] 0 0
Duration of objective response (DOR)
Timepoint [7] 0 0
Up to 27 months

Eligibility
Key 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 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 (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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
17/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/03/2028
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Andrew Love Cancer Centre - Geelong
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kentucky
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
Brazil
State/province [3] 0 0
Barretos
Country [4] 0 0
Brazil
State/province [4] 0 0
Natal
Country [5] 0 0
Brazil
State/province [5] 0 0
São José do Rio Preto
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Sofia
Country [7] 0 0
France
State/province [7] 0 0
Lille
Country [8] 0 0
France
State/province [8] 0 0
Lyon Cedex 08
Country [9] 0 0
France
State/province [9] 0 0
Marseille
Country [10] 0 0
France
State/province [10] 0 0
Villejuif
Country [11] 0 0
Georgia
State/province [11] 0 0
Tbilisi
Country [12] 0 0
Germany
State/province [12] 0 0
Braunschweig
Country [13] 0 0
Germany
State/province [13] 0 0
Jena
Country [14] 0 0
Germany
State/province [14] 0 0
Leipzig
Country [15] 0 0
Germany
State/province [15] 0 0
Ulm
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
Hungary
State/province [17] 0 0
Gyongyos
Country [18] 0 0
Italy
State/province [18] 0 0
Meldola (fc)
Country [19] 0 0
Italy
State/province [19] 0 0
Milano
Country [20] 0 0
Italy
State/province [20] 0 0
Napoli
Country [21] 0 0
Italy
State/province [21] 0 0
Roma
Country [22] 0 0
Italy
State/province [22] 0 0
Verona
Country [23] 0 0
Japan
State/province [23] 0 0
Hokkaido, Sapporo
Country [24] 0 0
Japan
State/province [24] 0 0
Hyogo, Kobe
Country [25] 0 0
Japan
State/province [25] 0 0
Osaka, Hirakata
Country [26] 0 0
Japan
State/province [26] 0 0
Shizuoka, Sunto-gun
Country [27] 0 0
Japan
State/province [27] 0 0
Tokyo, Koto-ku
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Suwon-si
Country [30] 0 0
Mexico
State/province [30] 0 0
Ciudad de México
Country [31] 0 0
Mexico
State/province [31] 0 0
Mexico
Country [32] 0 0
Mexico
State/province [32] 0 0
Tlajomulco de Zuñiga
Country [33] 0 0
Moldova, Republic of
State/province [33] 0 0
Chisinau
Country [34] 0 0
Poland
State/province [34] 0 0
Gliwice
Country [35] 0 0
Poland
State/province [35] 0 0
Lublin
Country [36] 0 0
Romania
State/province [36] 0 0
Bucharest
Country [37] 0 0
Singapore
State/province [37] 0 0
Singapore
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Malaga
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
Thailand
State/province [41] 0 0
Bangkoknoi
Country [42] 0 0
Turkey
State/province [42] 0 0
Adana
Country [43] 0 0
Turkey
State/province [43] 0 0
Ankara
Country [44] 0 0
Turkey
State/province [44] 0 0
Istanbul
Country [45] 0 0
Turkey
State/province [45] 0 0
Izmir
Country [46] 0 0
United Kingdom
State/province [46] 0 0
London
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
clintriage.rdg@boehringer-ingelheim.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
When will data be available (start and end dates)?
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Available to whom?
For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06806852