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A Randomized, 2-Arm Study to Evaluate the Efficacy and Safety of CRB-701 Compared With Investigator's Choice of Capecitabine, Cetuximab, or Docetaxel in Participants With Recurrent or Metastatic Oropharyngeal Squamous Cell Carcinoma Previously Treated With Platinum-based Chemotherapy and a PD-(L)1 Inhibitor

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Trial Profile

A Randomized, 2-Arm Study to Evaluate the Efficacy and Safety of CRB-701 Compared With Investigator's Choice of Capecitabine, Cetuximab, or Docetaxel in Participants With Recurrent or Metastatic Oropharyngeal Squamous Cell Carcinoma Previously Treated With Platinum-based Chemotherapy and a PD-(L)1 Inhibitor

Status: Not yet recruiting
Phase of Trial: Phase II/III

Latest Information Update: 20 Aug 2026

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At a glance

  • Drugs CRB 701 (Primary) ; Capecitabine; Cetuximab; Docetaxel
  • Indications Head and neck cancer; Oropharyngeal cancer; Squamous cell cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms TEMPO-1
  • Sponsors Corbus Pharmaceuticals

Most Recent Events

  • 20 Aug 2026 Status changed from planning to not yet recruiting.
  • 28 Jul 2026 According to Corbus Pharmaceuticals media release, company announced that the U.S. Food and Drug Administration (FDA) has cleared the start of this trial in second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC). Company expects to initiate enrollment in TEMPO-1 in September 2026.
  • 26 May 2026 According to Corbus Pharmaceuticals media release, Corbus is on track to initiate a registrational study of CRB-701 in 2L OPSCC (TEMPO-1) in the summer of 2026. Broad alignment was reached with the U.S. FDA on the trial design for a randomized controlled study (n=250), which will explore the efficacy and safety of CRB-701 compared to investigator's choice of monotherapy with ORR as the primary endpoint for potential accelerated approval and potential full approval based on OS benefit.

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