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Trial Title:
INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC
NCT ID:
NCT06295731
Condition:
Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Pembrolizumab
Conditions: Keywords:
OX40 receptor agonist
PD-L1 positive
Pembrolizumab
Immunotherapy
Chemotherapy-free
HNSCC
Head and Neck Cancer
Keytruda
Oropharyngeal cancer
Hypopharyngeal cancer
Laryngeal cancer
Oral cancer
INBRX-106
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
Phase 2: open label; Phase 3: double-blind
Intervention:
Intervention type:
Drug
Intervention name:
INBRX-106
Description:
INBRX-106 by intravenous (IV) infusion, given every 3 weeks (QW3)
Arm group label:
INBRX-106 plus pembrolizumab
Arm group label:
pembrolizumab monotherapy (+ placebo in phase 3 part)
Other name:
Hexavalent OX40 agonist antibody
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)
Arm group label:
INBRX-106 plus pembrolizumab
Arm group label:
pembrolizumab monotherapy (+ placebo in phase 3 part)
Other name:
Keytruda
Summary:
This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety
of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody
pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for
patients with locally advanced recurrent or metastatic head and neck squamous cell
carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined
proportion score (CPS) ≥20.
Criteria for eligibility:
Criteria:
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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Phone:
800-826-4673
Investigator:
Last name:
Victoria M Villaflor, MD
Email:
Principal Investigator
Facility:
Name:
Mid Florida Hematology and Oncology Center
Address:
City:
Orange City
Zip:
32763
Country:
United States
Status:
Recruiting
Contact:
Phone:
866-977-6322
Investigator:
Last name:
Santosh Nair, MD
Email:
Principal Investigator
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Phone:
617-726-8054
Investigator:
Last name:
Jong Park, MD
Email:
Principal Investigator
Facility:
Name:
Washington University St. Louis
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Phone:
314-747-8092
Investigator:
Last name:
Douglas Adkins, MD
Email:
Principal Investigator
Facility:
Name:
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Contact:
Phone:
402-334-4773
Investigator:
Last name:
Yungpo B. Su, MD
Email:
Principal Investigator
Facility:
Name:
Christus St. Vincent Regional Cancer Center
Address:
City:
Santa Fe
Zip:
87505
Country:
United States
Status:
Recruiting
Contact:
Phone:
505-913-8900
Investigator:
Last name:
Andrea Teague, MD
Email:
Principal Investigator
Start date:
May 14, 2024
Completion date:
May 2029
Lead sponsor:
Agency:
Inhibrx Biosciences, Inc
Agency class:
Industry
Source:
Inhibrx Biosciences, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06295731