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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06295731




Registration number
NCT06295731
Ethics application status
Date submitted
22/02/2024
Date registered
6/03/2024
Date last updated
3/06/2025

Titles & IDs
Public title
INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS=20 HNSCC
Scientific title
A Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS =20) (HexAgon-HN)
Secondary ID [1] 0 0
EU CT
Secondary ID [2] 0 0
INBRX106-01-201
Universal Trial Number (UTN)
Trial acronym
HexAgon-HN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma (HNSCC) 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 - INBRX-106
Treatment: Drugs - Pembrolizumab

Experimental: INBRX-106 plus pembrolizumab - Participants will receive INBRX-106 plus pembrolizumab, both given by intravenous (IV) infusion every 3 weeks (QW3)

Active comparator: pembrolizumab monotherapy (+ placebo in phase 3 part) - Participants will receive pembrolizumab (plus placebo in Phase 3), given by intravenous (IV) infusion every 3 weeks (QW3)


Treatment: Drugs: INBRX-106
INBRX-106 by intravenous (IV) infusion, given every 3 weeks (QW3)

Treatment: Drugs: Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 2: Objective Response Rate (ORR)
Timepoint [1] 0 0
up to 6 months
Primary outcome [2] 0 0
Phase 3: Progression-Free Survival (PFS)
Timepoint [2] 0 0
From randomization to first occurrence of progressive disease (PD) or death (up to 4 years)
Primary outcome [3] 0 0
Phase 3: Overall Survival (OS)
Timepoint [3] 0 0
From randomization until death from any cause (up to 4 years)
Secondary outcome [1] 0 0
Phase 3: Objective Response Rate (ORR)
Timepoint [1] 0 0
From randomization until treatment discontinuation (up to 2 years)
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
From the first occurrence of a documented objective response to PD or death (up to 4 years)
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR)
Timepoint [3] 0 0
From randomization until treatment discontinuation (up to 2 years)
Secondary outcome [4] 0 0
Phase 3: Time to Chemotherapy (TTCtx)
Timepoint [4] 0 0
From randomization until the start of chemotherapy or death (up to 4 years)
Secondary outcome [5] 0 0
Time to Confirmed Deterioration (TTCD) in Pain Presence and Interference
Timepoint [5] 0 0
From randomization until treatment discontinuation (up to 2 years)
Secondary outcome [6] 0 0
TTCD in physical functioning (PF)
Timepoint [6] 0 0
From randomization until treatment discontinuation (up to 2 years)
Secondary outcome [7] 0 0
TTCD in role functioning (RF)
Timepoint [7] 0 0
From randomization until treatment discontinuation (up to 2 years)
Secondary outcome [8] 0 0
TTCD in Global Health Status/quality of life (GHS/QoL)
Timepoint [8] 0 0
From randomization until treatment discontinuation (up to 2 years)
Secondary outcome [9] 0 0
Incidence and severity of Adverse Events (AEs)
Timepoint [9] 0 0
Up to approximately 24 months
Secondary outcome [10] 0 0
Number of patients who experienced abnormalities in vital signs and clinical laboratory parameters
Timepoint [10] 0 0
Up to approximately 24 months

Eligibility
Key inclusion criteria
* Has histologically or cytologically confirmed diagnosis of metastatic, recurrent head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies.
* Has tumor PD-L1 expression of CPS =20. Tumor tissue must be provided for PD-L1 biomarker analysis.
* Has human papilloma virus (HPV) testing results for oropharyngeal cancer by p16 immunohistochemistry (IHC) testing.
* Has measurable disease per RECIST 1.1 guidelines.
* Has the primary tumor location of the oral cavity, oropharynx, hypopharynx, or larynx.
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Female patients of childbearing potential must have a negative highly sensitive pregnancy test within 72 hours prior to randomization and must not be breastfeeding.
* Male and female patients of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use a highly effective method of contraception.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has primary tumor site (any histology) of nasopharynx or salivary glands or occult primary site.
* Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for locally advanced unresectable or metastatic HNSCC.

* Prior systemic therapy completed >6 months prior to signing informed consent is allowed if given as part of multimodal treatment for locoregionally advanced disease with curative intent, and no PD/recurrence occurred within 6 months of its completion. Prior systemic immunotherapy in the locoregionally advanced disease with curative intent, including but not limited to anti-PD-(L)1 agents, is allowed if PD/recurrence occurred =12 months after its completion.
* Has clinically active central nervous system metastases and/or carcinomatous meningitis.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Rapidly progressing disease or with features that may confer a high risk of tumor-associated hemorrhage or uncontrolled tumor pain.
* Current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2029
Actual
Sample size
Target
410
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
Belgium
State/province [17] 0 0
Jette
Country [18] 0 0
Belgium
State/province [18] 0 0
Namur
Country [19] 0 0
Belgium
State/province [19] 0 0
Sint-Niklaas
Country [20] 0 0
Italy
State/province [20] 0 0
Milan
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Gyeongsangnam-do
Country [22] 0 0
Malaysia
State/province [22] 0 0
Kelantan
Country [23] 0 0
Malaysia
State/province [23] 0 0
Sarawak
Country [24] 0 0
Malaysia
State/province [24] 0 0
Putrajaya
Country [25] 0 0
Poland
State/province [25] 0 0
Konin
Country [26] 0 0
Poland
State/province [26] 0 0
Piotrków Trybunalski
Country [27] 0 0
Romania
State/province [27] 0 0
Dolj
Country [28] 0 0
Romania
State/province [28] 0 0
Bucharest
Country [29] 0 0
Romania
State/province [29] 0 0
Cluj-Napoca, Cluj
Country [30] 0 0
Spain
State/province [30] 0 0
Catalonia
Country [31] 0 0
Spain
State/province [31] 0 0
Gracia
Country [32] 0 0
Spain
State/province [32] 0 0
Navarra
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Coruña
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Spain
State/province [36] 0 0
Valencia
Country [37] 0 0
Taiwan
State/province [37] 0 0
Beitou District / R.O.C.
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Aberdeen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Inhibrx Biosciences, Inc
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Lead
Address 0 0
Inhibrx Biosciences, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director - Inhibrx
Address 0 0
Country 0 0
Phone 0 0
858-500-7833
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06295731