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Checkpoint Inhibitor

CD40 Agonist + PD-1 Inhibitor for Head and Neck Cancer

Phase 1
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
3. Body weight > 30kg
2. Age ≥18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the safety and immune system effects of a combination of two drugs, LVGN7409 and LVGN3616, in patients with a specific type of head and neck cancer.

Who is the study for?
Adults over 18 with HPV-negative squamous cell carcinoma in the head and neck area, who are not pregnant, can join this trial. They must weigh more than 30kg, have a life expectancy of at least 12 weeks, and agree to use effective contraception. Their cancer should be resectable (can be removed by surgery), they need to have a sample of their tumor available for study, and their major organs must function well.
What is being tested?
The trial is testing LVGN7409 (a CD40 agonist) combined with LVGN3616 (a PD-1 inhibitor) on patients before they undergo surgical removal of their cancer. It's an early-phase study looking at how safe these drugs are together and what effects they have on the immune system.
What are the potential side effects?
Potential side effects may include reactions related to stimulating the immune system such as flu-like symptoms, fatigue, skin reactions or potential organ inflammation due to increased immune activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My body weight is more than 30kg.
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I am 18 years old or older.
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I have a non-FNA tumor tissue sample available for the study.
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My blood, liver, and kidney functions are within normal ranges required for the study.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Pathological Response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Arm A: PD1Active Control1 Intervention
Subjects in this arm will receive one dose of LVGN3616 (300mg).
Group II: Arm B: PD1 + CD40Active Control2 Interventions
Subjects in this arm will receive one dose of LVGN3616 (300mg) followed by one dose of CD40 LVGN7409 (1mg/kg).

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,601 Total Patients Enrolled
~13 spots leftby Mar 2028
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