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Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

ConditionsRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorNational Cancer Institute (NCI)

About this trial

This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. 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. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must be between 18 and 79 years of age

Patient must have locoregionally recurrent or second primary HNSCC (oral cavity, oropharynx, larynx, hypopharynx) in a previously radiated field

Patient must have undergone surgery with gross total resection and must be randomized within 8 weeks of surgery

Positive margins and/or extra nodal extension (ENE)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carboplatin

    Drug

    Given IV

  • Cisplatin

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Intensity-Modulated Radiation Therapy

    Radiation

    Undergo IMRT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Pembrolizumab

    Biological/Vaccine

    Given IV

  • Proton Beam Radiation Therapy

    Radiation

    Undergo PBRT

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: Arm B (cisplatin, carboplatin, IMRT, PBRT)Active comparator 6 interventions
Group B: Arm C (pembrolizumab)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Kaplan-Meier estimates will be used to estimate the OS distributions. A log-rank test with one-sided 10% type I error will be used for the comparison.

Time frame
From randomization to date of death from any cause, measured at 2 years
2

Incidence of adverse events

Assessed using Common Terminology Criteria for Adverse Events. An 80% confidence interval around the hazard ratio of the two experimental arms will be calculated. Toxicity will be compared between the two treatment arms. Toxicity will be examined by arm and compared using the Fisher's exact test.

Time frame
Up to 5 years from date of registration

Secondary outcomes

1

Disease free survival

Time frame
From the date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 5 years from date of registration
2

PD-L1 expression

Defined as Combined Positive Score \>= 20 as a predictive marker of efficacy.

Time frame
Up to 5 years from date of registration

Other outcomes

Sponsors and contacts

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

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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