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Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer

ConditionsHead and Neck Carcinoma of Unknown PrimaryLocally Recurrent Head and Neck Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Pharyngeal Squamous Cell CarcinomaResectable Head and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed either persistent and/ or locoregionally recurrent HNSCC of oral cavity, pharynx, larynx, unknown primary head and neck (H&N) squamous cell carcinoma

Resectable disease as determined by the surgeon and team

Eastern Cooperative Oncology Group (ECOG) performance status (PS) < 2

At least 18 years of age

Disqualifiers

Requirement of immunosuppressive therapy within 14 days of randomization

Salivary gland carcinomas, lip carcinoma, adenocarcinoma of the skin

Prior use of immune checkpoint blockade agent

History of human immunodeficiency virus (HIV), hepatitis B, C: Participants who test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection, those who test positive for human immunodeficiency virus (HIV) or have known acquired immunodeficiency syndrome (AIDS)

Trial design

Design model

Parallel

Treatments tested in this trial

  • External Beam Radiation Therapy

    Radiation

    Undergo EBRT

  • Intraoperative Radiation Therapy

    Radiation

    Undergo IORT

  • Pembrolizumab

    Biological/Vaccine

    Given IV

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Salvage Surgery

    Procedure/Surgery

    Undergo salvage surgery

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Arm A (pembrolizumab, salvage surgery, IORT)Experimental treatment 4 interventions
Group B: Arm B (pembrolizumab, EBRT, salvage surgery, IORT)Experimental treatment 5 interventions
Group C: Arm C (pembrolizumab, EBRT, salvage surgery, IORT)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Summarized by treatment group. All on-study adverse events (AEs), treatment-related AEs, serious (S)AEs, and treatment-related SAEs will be tabulated using worst grade per NCI CTCAE version 4.0 criteria by system organ class and preferred term. On-study lab parameters including hematology, chemistry, liver function, and renal function will also be summarized using worst grade NCI CTCAE v 4.0 criteria. Toxicity will be measured as the rate of grade 3 and 4 adverse events and will be calculated through using the exact binomial distribution method with a 2- sided 95% confidence interval.

Time frame
Up to 100 days after last dose of study drug
2

Health related quality of life

Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30. Analysis will be performed in all randomized participants who have an assessment at baseline and at least one follow-up assessment using linear mixed model for repeated measures to model the changes overtime for each arm.

Time frame
Up to 5 years

Secondary outcomes

1

Objective-response rate (ORR)

ORR including complete response rate, partial response rate, and stable disease rate will be calculated using the exact binomial distribution method with a 2- sided 95% confidence interval among patients who obtain a least one dose of study drug.

Time frame
Up to 5 years
2

Local control rate

Analyses will be conducted using Kaplan-Meier method for each arm. The hazard ratio and corresponding two-sided 95% CI will be estimated using a Cox proportional hazards model, with treatment group as a single covariate.

Time frame
From the first day of therapy to the occurrence of a local and/or regional recurrence (whichever comes first), and death from any cause other than distant metastasis, assessed up to 24 months
3

Overall survival

Analyses will be conducted using Kaplan-Meier method for each arm. The hazard ratio and corresponding two-sided 95% CI will be estimated using a Cox proportional hazards model, with treatment group as a single covariate.

Time frame
Up to 5 years
4

Progression-free survival (PFS)

Analyses will be conducted using Kaplan-Meier method for each arm. The PFS medians with 95% confidence intervals (CIs), and PFS at 6, 12, and 24 months with 95% CIs will be estimated a two-sided log-rank test. The hazard ratio and corresponding two-sided 95% CI will be estimated using a Cox proportional hazards model, with treatment group as a single covariate, stratified by the above factors.

Time frame
From the first day of the therapy to the appearance of local or regional recurrence, distant metastases, secondary primary cancer or death from any cause, assessed up to 24 months

Other outcomes

Sponsors and contacts

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

Ohio State University Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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