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

NCT02641093 | Active Not Recruiting Phase 2 Results DMC

• 1 other identifier: UCCI-HN-15-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment Related Adverse Effects

  Number of participants with treatment related adverse effects as assessed using CTCAE v4.0 of pembrolizumab when combined with radiation alone and chemoradiation. Compared as percentage of grade 3 and 4 adverse events with historical control percentages.

  All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution.

• Disease Free Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation

  • High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins.

  1 year

• Disease Free Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation

  • Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins.

  1 year

Secondary Outcomes (3)

• Tumor Immune Response to Pembrolizumab as Defined by PD-L1 CPS in the Baseline Tumor Tissue

  1 week between receiving a pre-surgery dose of pembrolizumab and surgery when the biopsy was taken

• Overall Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation

  1 year

• Overall Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation

  1 year

Study Arms (1)

Pembrolizumab

EXPERIMENTAL

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

Drug: Pembrolizumab; Procedure: Surgery; Radiation: Radiation Therapy; Drug: Cisplatin

Interventions

Pembrolizumab DRUG

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

Also known as: Keytruda

Pembrolizumab

Surgery PROCEDURE

gross total surgical resection

Pembrolizumab

Radiation Therapy RADIATION

60-66 Gy over 6 weeks

Pembrolizumab

Cisplatin DRUG

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

Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for resection with one or more of the following
• Any T stage with ≥ N2 disease;
• T4 disease, any N stage;
• T3 Oral Cavity, any N stage; or
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Trisha Wise-Draper: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

University of Louisville - James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

pembrolizumab; Surgical Procedures, Operative; Radiotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Trisha Wise-Draper, MD, PhD
• Organization: University of Cincinnati

wiseth@ucmail.uc.edu

513 558 2826

Study Officials

• Trisha Wise-Draper, MD, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 29, 2015
• Study Start: January 1, 2016
• Primary Completion: April 16, 2021
• Study Completion (Estimated): November 2, 2026
• Last Updated: May 4, 2026
• Results First Posted: May 6, 2023

Record last verified: 2026-04

Locations

US (6)