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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo PET-CT and CT scan

  • Ivonescimab

    Biological/Vaccine

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET-CT scan

  • Surgical Procedure

    Procedure/Surgery

    Undergo surgical dissection

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Treatment (ivonescimab)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Major pathologic response rate

The major pathologic response (MPR) rate is defined as the proportion of patients achieving major pathologic response out of all response-evaluable patients. This proportion will be estimated as the number of patients with MPR divided by the total number of patients response-evaluable for pathologic response. This estimate will be presented along with a Wilson score 95% confidence interval.

Time frame
Up to 36 months

Secondary outcomes

1

Neoadjuvant ivonescimab related toxicities

Toxicities per Common Terminology Criteria for Adverse Events version 5.0 will be summarized by number and percentage of participants with adverse events in different categories (e.g., causal relationship, grade, etc.). All safety data will be listed individually by participant and appropriately summarized.

Time frame
Up to 36 months
2

Overall response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1

Assessed per RECIST v1.1. The estimate will be presented along with a Wilson score 95% confidence interval.

Time frame
Up to 36 months
3

Pathologic complete response rate

The estimate will be presented along with a Wilson score 95% confidence interval.

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan Rogel Cancer Center

Lead sponsor

Summit Therapeutics

Collaborator

Source ClinicalTrials.gov
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