Health Trials

Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer

ConditionsAdvanced Head and Neck Squamous Cell CarcinomaResectable Head and Neck Squamous Cell CarcinomaStage II Head and Neck Cutaneous Squamous Cell CarcinomaStage III Head and Neck Cutaneous Squamous Cell CarcinomaStage IV Head and Neck Cutaneous Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan Rogel Cancer Center

About this trial

This phase II trial tests how well ivonescimab before surgery works in treating patients with stage II-IV head and neck cancer that can be removed by surgery (resectable). Ivonescimab is a bispecific monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A bispecific monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).

Eligibility criteria

Qualifiers

At least 18 years of age

PD-L1 combined positive score (CPS) >= 1

Histologically documented advanced stage mucosal HNSCC (stage II-IV), for which surgery would be recommended in routine clinical practice

Primary tumor is amenable to fresh biopsy or availability of archival fresh frozen primary tissue

Disqualifiers

Prior radiation therapy for treatment of the current mucosal HNSCC (patients undergoing salvage resection are excluded)

Prior neck dissection on the side of current mucosal HNSCC

Major surgical procedures or serious trauma within 4 weeks prior to enrollment. Minor local procedures (excluding central venous catheterization, port implantation, and tumor biopsy) within 3 days prior to planned cycle 1, day 1

History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment

Trial design

Treatments tested in this trial

  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Ivonescimab
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Surgical Procedure

Treatment groups

28 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Michigan Rogel Cancer Center

Lead sponsor

Summit Therapeutics

Collaborator

Source ClinicalTrials.gov