Ivonescimab for Head and Neck Cancer

(SENIOR-HN Trial)

Overseen By Cancer AnswerLine

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: Anticoagulants, Corticosteroids

Disqualifiers: Radiation therapy, Neck dissection, Autoimmune disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 9 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ivonescimab, a bispecific monoclonal antibody, to determine its effectiveness in stopping the growth and spread of head and neck cancer before surgery. It targets individuals with stage II-IV head and neck cancer that can be surgically removed. Candidates recommended for surgery who have not undergone previous radiation or major surgery for this cancer may qualify. Participants will receive the treatment through an IV over several cycles, followed by standard surgery. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, if you are on anticoagulants or corticosteroids, there are specific conditions you must meet to participate. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that ivonescimab is likely to be safe for humans?

Research has shown that ivonescimab is generally safe for patients with certain types of head and neck cancer. Studies have found that ivonescimab, whether used alone or with another drug, is usually well-tolerated and does not cause serious side effects. Specifically, trials with patients who have PD-L1-positive recurrent or metastatic head and neck cancer reported no severe side effects related to the treatment.

The trial is currently in the middle phase of testing. While some evidence of safety exists, more information is needed to confirm these results. Overall, current research suggests that ivonescimab could be a promising and safe option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for head and neck cancer, which often involve chemotherapy, radiation, or targeted therapies, ivonescimab offers a novel approach by harnessing the power of immunotherapy. This treatment is unique because it acts as a bispecific antibody, targeting two different antigens that are involved in cancer growth. Researchers are excited about ivonescimab because it has the potential to engage the immune system more effectively, potentially leading to better outcomes and fewer side effects compared to traditional therapies. By enhancing the body's natural defense mechanisms, ivonescimab represents a promising advancement in the fight against head and neck cancer.

What evidence suggests that ivonescimab might be an effective treatment for head and neck cancer?

Research has shown that ivonescimab may help treat head and neck cancer. Studies have demonstrated that ivonescimab, used alone or with ligufalimab, effectively shrinks tumors and improves survival rates for patients with head and neck squamous cell carcinoma (HNSCC). In this trial, participants will receive ivonescimab alone. The treatment is considered safe for patients. These findings suggest that ivonescimab could effectively reduce cancer in the head and neck area. ^{1 2 3 6 7}

Who Is on the Research Team?

Paul L Swiecicki

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage II-IV head and neck cancer that can be surgically removed. Participants must have a PD-L1 score of at least 1, an ECOG performance status of 0 or 1, adequate blood cell counts, and normal liver function. They should also be able to provide a fresh biopsy or archival tissue.

Inclusion Criteria

* 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive ivonescimab IV over 60-120 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 3 cycles.

9 weeks

3 visits (in-person)

Surgery

Standard of care surgical dissection is performed 4-8 weeks after the last dose of ivonescimab.

4-8 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PET-CT, CT or MRI, and collection of blood samples.

Up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Ivonescimab

Trial Overview The trial is testing the effectiveness of Ivonescimab given before surgery in patients with resectable head and neck cancer. Ivonescimab is a bispecific monoclonal antibody designed to hinder tumor growth and spread by targeting specific antigens.

How Is the Trial Designed?

Group I: Treatment (ivonescimab) Experimental Treatment 7 Interventions

Patients receive ivonescimab IV over 60-120 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Then 4-8 weeks after last dose of ivonescimab, patient undergoes standard of care surgical dissection. Patients undergo PET-CT and may undergo biopsy at screening, as well as CT or MRI and collection of blood samples throughout the trial.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Summit Therapeutics

Industry Sponsor

Trials

18

Recruited

4,500+

Citations

1. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02456-6/fulltext

876P Evaluation of the safety and efficacy of ivonescimab ... Ivonescimab with or without ligufalimab showed promising anti-tumor activity in pts with PD-L1 positive R/M HNSCC with a favorable safety profile.

2. akesobio.com akesobio.com/en/media/akeso-news/240918-2/

Akeso Published Ivonescimab plus Ligufalimab as First- ... When combined with ligufalimab, both tumor shrinkage and survival benefits demonstrated further improvement from ivonescimab alone. Both ...

3. smmttx.com smmttx.com/wp-content/uploads/2024/09/ESMO-2024_Ivonescimab_AK117-201-poster_L4.pdf

Ivonescimab in Combination With Ligufalimab as ... • Here, we present data on the efficacy and safety of ivonescimab, both with and without ligufalimab, ... HNSCC, head and neck squamous cell ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07094685

Study Details | NCT07094685 | Ivonescimab Before ... 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 ...

5. onclive.com onclive.com/view/ivonescimab-plus-chemo-might-be-a-new-soc-in-advanced-squamous-nsclc

Ivonescimab Plus Chemo Might Be a New SOC ... - OncLive Ivonescimab plus chemotherapy significantly improved PFS over tislelizumab in advanced squamous NSCLC, with a 40% reduction in progression risk.

6. prnewswire.com prnewswire.com/news-releases/akeso-published-ivonescimab-plus-ligufalimab-as-first-line-treatment-for-pd-l1positive-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-at-esmo-2024-302248430.html

Akeso Published Ivonescimab plus Ligufalimab as First ... The safety profile of the ivonescimab for first-line treatment of PD-L1-positive R/M HNSCC was manageable, with no treatment-related adverse ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11033648/

Phase 1a dose escalation study of ivonescimab (AK112/ ... This study supports that ivonescimab has manageable safety profiles, promising efficacy signals. Several studies with ivonescimab monotherapy or ...