Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2025-11-02

Brief Summary

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The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pembrolizumab

Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type DRUG

Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.

Surgery

Intervention Type PROCEDURE

gross total surgical resection

Radiation Therapy

Intervention Type RADIATION

60-66 Gy over 6 weeks

Cisplatin

Intervention Type DRUG

Weekly during radiation therapy for 6 doses only for patients with high risk pathological features

Interventions

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Pembrolizumab

Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.

Intervention Type DRUG

Surgery

gross total surgical resection

Intervention Type PROCEDURE

Radiation Therapy

60-66 Gy over 6 weeks

Intervention Type RADIATION

Cisplatin

Weekly during radiation therapy for 6 doses only for patients with high risk pathological features

Intervention Type DRUG

Other Intervention Names

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Keytruda

Eligibility Criteria

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Inclusion Criteria

* Patients eligible for resection with one or more of the following

1. Any T stage with ≥ N2 disease;
2. T4 disease, any N stage;
3. T3 Oral Cavity, any N stage; or
4. Clinical evidence of extra-capsular extension on scans.
* Must be willing to undergo definitive resection with neck dissection.
* Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
* Adequate labs
* Appropriate staging imaging.

Exclusion Criteria

* Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment.
* Nasopharyngeal or sinonasal carcinoma
* Confirmed metastatic disease
* Human Papillomavirus (HPV)+ disease of the oropharynx
* Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No