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Checkpoint Inhibitor

Combination Therapy for Head and Neck Cancer

Phase 1

Recruiting

Led By Kedar Kirtane, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be willing and able to undergo an apheresis procedure.

Participants given pembrolizumab monotherapy must have a composite positive score ≥ 1.

Must not have

Participants who have received any previous treatment with a PD-1 or PD-L1 inhibitor, including but not limited to: nivolumab, atezolizumab, pembrolizumab, avelumab, or durvalumab.

Participants with a serious cardiac condition, such as uncontrolled hypertension, concurrent congestive heart failure, prior history of Class III/IV cardiac disease (New York Heart Association [NYHA]), left ventricular ejection fraction (LVEF) <45% at baseline, history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment, unless approved by the Sponsor (MCC). Participants who are > 60 years of age must undergo cardiology clearance exam and cardiac stress test, unless performed within the last 6 months and there has been no clinical change with respect to heart function.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for advanced head and neck cancer. It involves giving patients a combination of chemotherapy, a drug called TIL (TBio-4101), and two other drugs called

Who is the study for?

This trial is for adults with advanced head and neck squamous cell carcinoma (HNSCC) who have seen their cancer progress despite treatment with pembrolizumab or a combination of pembrolizumab and platinum-based chemotherapy.

What is being tested?

The study tests TBio-4101, a type of tumor-infiltrating lymphocyte therapy, after chemo that reduces immune cells. It's followed by aldesleukin to boost the immune system and more pembrolizumab to help fight the cancer.

What are the potential side effects?

Possible side effects include reactions from the infusion, low blood counts, fatigue, nausea, fever due to aldesleukin; plus typical issues from immunotherapies like skin rash or inflammation in organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing and able to undergo a procedure to collect my blood cells.

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I have a score of 1 or more for pembrolizumab treatment eligibility.

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I do not have HIV, hepatitis B, or active hepatitis C.

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My cancer is a specific type that has returned or spread and hasn't been treated yet.

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I have a tumor large enough for tissue removal and assessment.

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I finished any cancer treatments 3 weeks ago, and side effects are mild except for hair loss or skin color changes.

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I am between 18 and 75 years old.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken drugs like nivolumab or pembrolizumab before.

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I do not have serious heart conditions and, if over 60, I've had a recent heart check-up.

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My lung function tests show reduced breathing capacity.

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I am not pregnant or breastfeeding.

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I have had cell therapy or an organ transplant before.

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I need long-term blood thinner treatment that can't be stopped or switched.

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I have a condition that significantly weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability

Secondary study objectives

Assess the feasibility of TBio-4101

Disease Control Rate (DCR)

Durable Response Rate (DRR)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: TIL Harvest/Standard of care Treatment PhaseExperimental Treatment2 Interventions

Participants will undergo tumor harvest for TIL and then receive 2 to 3 cycles of pembrolizumab or pembrolizumab/platinum chemotherapy (cisplatin or carboplatin / 5-FU) as per standard of care.

Group II: TBio-4101 TreatmentExperimental Treatment6 Interventions

Participants without radiographic response (progressive disease) after pembrolizumab or pembrolizumab/platinum chemotherapy, and who meet eligibility requirements, will transition to receive TBio-4101. Participants will receive TBio-4101 infusion and after completion of TBio-4101 infusion, IL-2 will be administered every 8 hours, for up to 6 doses. Finally, pembrolizumab will be administered on Day 14, Day 35, and Day 56 and Q6W (beginning Week 12) thereafter for up to 2 years until discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Pembrolizumab

2017

Completed Phase 3

~3150