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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

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