Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Pembrolizumab

Immunomodulating Agents

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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

Participants will receive pembrolizumab (plus placebo in Phase 3), given by intravenous (IV) infusion every 3 weeks (QW3)

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

INBRX-106

Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)

Study Director - Inhibrx

Victoria M Villaflor, MD

Santosh Nair, MD

Andrea Teague, MD

Clinical Lead

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.

Phase 2: open label; Phase 3: double-blind

INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC

Phase 2/3, Randomized Study of OX40 Agonist INBRX-106 With Pembrolizumab vs Pembrolizumab as First Line Treatment for Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1(CPS ≥20)

ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on 2 consecutive occasions ≥4 weeks apart, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

PFS is defined as the time from randomization to first occurrence of PD, as determined by the Investigator according to RECIST v 1.1, or death from any cause (whichever occurs first).

OS is the time from randomization to death due to any cause

ORR is defined as the proportion of patients with a CR or PR on 2 consecutive occasions ≥4 weeks apart, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

DOR is defined as the time from the first occurrence of a documented objective response to PD, as determined by the Investigator according to RECIST v1.1, or death from any cause (whichever occurs first)

CBR is defined as the proportion of patients with stable disease (SD) for ≥12 weeks or a CR or PR, as determined by the Investigator according to RECIST v1.1.

TTCtx is defined as the time from randomization until the start date of chemotherapy or death from any cause (whichever occurs first).

TTCD in pain presence and interference is defined as the time from randomization to the first documentation of ≥10-point increase in pain score, as determined using the European Organization for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) questionnaire

TTCD in PF is defined as the time from randomization to the first documentation of a ≥10 point decrease from baseline in the Quality of Life-Core 30 (EORTC QLQ-C30) linearly transformed PF scale score.

TTCD in RF is defined as the time from randomization to the first documentation of a ≥10 point decrease from baseline in the Quality of Life-Core 30 (EORTC QLQ-C30) linearly transformed RF scale score.

TTCD in GHS/QoL is defined as the time from randomization to the first documentation of a ≥10 point decrease from baseline in the Quality of Life-Core 30 (EORTC QLQ-C30) linearly transformed GHS/QoL scale score.

Incidence will be reported as the number of participants with at least one adverse event, with severity determined according to the National Cancer Institute Criteria for Adverse Events, version 5 (NCI CTCAE v 5.0)

Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature. Clinical laboratory parameter include hematology and biochemistry tests over the course of the study.

Spots Global Cancer Trial Database for ox40 receptor agonist