ACTIVE_NOT_RECRUITING

CD40 Agonist and PD-1 Inhibitor in HNSCC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Prospective, open-label, phase 1 study of CD40 agonist (LVGN7409) and PD-1 inhibition (LVGN3616 or nivolumab) in patients with resectable Human Papillomavirus (HPV)-negative mucosal head/neck squamous cell carcinoma (HNSCC). This protocol proposes to study the safety and immunological effects of LVGN7409, a CD40 agonistic antibody, when administered in combination with PD-1 inhibition prior to surgical resection.

Official Title

Neoadjuvant/Phase 1 Study of CD40 Agonist (LVGN7409) and PD-1 Inhibitor (LVGN3616) in Patients With Resectable HPV-negative Mucosal Head/Neck Squamous Cell Carcinoma (HNSCC)

Quick Facts

Study Start:2024-07-02

Study Completion:2028-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06159621

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 1\. Signed and dated written IRB-approved informed consent. * 2\. Age ≥18 years. * 3\. Body weight \> 30kg * 4\. Human Papillomavirus (HPV)-negative histologically confirmed mucosal squamous cell head and neck cancer (oral cavity, oropharynx, larynx, hypopharynx) for which definitive surgery is planned. Sites other than oropharynx are assumed to be HPV negative unless specifically shown otherwise. Oropharynx HPV status can be determined through p16 or nucleic acid testing (ISH). * 5\. Tumor tissue sample (non-cytology specimen) available prior to Study Treatment, either via archived non-FNA (fine needle aspirate) tumor biopsy specimen or fresh biopsy * 6\. Life expectancy of at least 12 weeks. * 7\. Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count) ≥ 1.5x109 cell/ml, platelets ≥75,000 /mm3, hemoglobin ≥9.0 g/dL, total serum bilirubin within 1.5 x upper limit of normal (ULN) unless Gilbert's, AST/ALT, within 2.5 x ULN, Albumin ≥3g/dL, and all tests performed within 4 weeks prior to administration of Study Treatment. * 8\. Eastern Cooperative Oncology Group (ECOG) with no clinically significant findings as assessed by the investigator. * 9\. ECOG performance status of 0-1. * 10\. Female patients of childbearing potential who are not abstinent and intend to be sexually active with a non-sterilized male partner must use at least 1 highly effective method of contraception from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after therapy). Non-sterilized male partners of a female patient of childbearing potential must use male condom plus spermicide throughout this period. Female patients should also refrain from breastfeeding throughout this period. * 11\. Able and willing to comply with all study procedures.	* 1\. Prior history of Head and Neck Squamous Cell Carcinoma (HNSCC) for which patient has undergone surgery or radiation involving the current planned surgical site. 1. Patients with vitiligo or alopecia 2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or type 1 Diabetes Mellitus (DM) controlled with insulin. 3. Any chronic skin condition that does not require systemic therapy. 4. Patients without active autoimmune disease in the last 5 years may be included but only after consultation with the study physician. 5. Patients with celiac disease controlled by diet alone. 11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent 12. History of another active malignancy except for non-melanoma skin cancer, lentigo maligna or other carcinoma in situ 13. History of active primary immunodeficiency. Patients with Human Immunodeficiency Virus (HIV) with undetectable HIV viral loads by standard clinical assays are eligible.

Inclusion Criteria

Exclusion Criteria

* 1\. Signed and dated written IRB-approved informed consent.
* 2\. Age ≥18 years.
* 3\. Body weight \> 30kg
* 4\. Human Papillomavirus (HPV)-negative histologically confirmed mucosal squamous cell head and neck cancer (oral cavity, oropharynx, larynx, hypopharynx) for which definitive surgery is planned. Sites other than oropharynx are assumed to be HPV negative unless specifically shown otherwise. Oropharynx HPV status can be determined through p16 or nucleic acid testing (ISH).
* 5\. Tumor tissue sample (non-cytology specimen) available prior to Study Treatment, either via archived non-FNA (fine needle aspirate) tumor biopsy specimen or fresh biopsy
* 6\. Life expectancy of at least 12 weeks.
* 7\. Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count) ≥ 1.5x109 cell/ml, platelets ≥75,000 /mm3, hemoglobin ≥9.0 g/dL, total serum bilirubin within 1.5 x upper limit of normal (ULN) unless Gilbert's, AST/ALT, within 2.5 x ULN, Albumin ≥3g/dL, and all tests performed within 4 weeks prior to administration of Study Treatment.
* 8\. Eastern Cooperative Oncology Group (ECOG) with no clinically significant findings as assessed by the investigator.
* 9\. ECOG performance status of 0-1.
* 10\. Female patients of childbearing potential who are not abstinent and intend to be sexually active with a non-sterilized male partner must use at least 1 highly effective method of contraception from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after therapy). Non-sterilized male partners of a female patient of childbearing potential must use male condom plus spermicide throughout this period. Female patients should also refrain from breastfeeding throughout this period.
* 11\. Able and willing to comply with all study procedures.

* 1\. Prior history of Head and Neck Squamous Cell Carcinoma (HNSCC) for which patient has undergone surgery or radiation involving the current planned surgical site.
1. Patients with vitiligo or alopecia
2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or type 1 Diabetes Mellitus (DM) controlled with insulin.
3. Any chronic skin condition that does not require systemic therapy.
4. Patients without active autoimmune disease in the last 5 years may be included but only after consultation with the study physician.
5. Patients with celiac disease controlled by diet alone. 11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent 12. History of another active malignancy except for non-melanoma skin cancer, lentigo maligna or other carcinoma in situ 13. History of active primary immunodeficiency. Patients with Human Immunodeficiency Virus (HIV) with undetectable HIV viral loads by standard clinical assays are eligible.

Contacts and Locations

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-02

Study Completion Date2028-03-01

Study Record Updates

Study Start Date2024-07-02

Study Completion Date2028-03-01

Terms related to this study

Additional Relevant MeSH Terms

Head and Neck Squamous Cell Carcinoma