Ordastobart (INBRX-106) Add-on to Pembrolizumab in 1L HPV+ PD-L1+ R/M OPSCC (HexAgon-HN)

Condition(s) studied

Investigational drug(s) / intervention(s)

INBRX-106: INBRX-106 0.1 mg/kg by intravenous (IV) infusion, given every 3 weeks (QW3)

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

Study summary

This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody ordastobart (INBRX-106) combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with recurrent or metastatic (R/M) HPV-positive Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC) expressing PD-L1.

Eligibility

Primary outcome measure(s)

• Phase 2: Objective Response Rate by investigator (ORRinv) — From randomization to progressive disease (PD) or death (up to 1 year)
  defined as the proportion of patients with complete response (CR) or partial response (PR) on 2 consecutive occasions ≥4 weeks apart, as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
• Phase 3: Progression-Free Survival by Investigator (PFSinv) — From randomization to PD or death (up to 4 years)
  defined as the time from randomization to first occurrence of PD, as determined by the Investigator according to RECIST 1.1, or death from any cause (whichever occurs first).
• Phase 3: Overall Survival (OS) — From randomization until death from any cause (up to 4 years)
  defined as the time from randomization to death from any cause.

Trial sites (89)

+ 49 more sites — see the full list on the official registry below.

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