The Addition of Pembrolizumab to Postoperative Radiotherapy in Cutaneous Squamous Cell Cancer of the Head and Neck

NCT03057613 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CASE6316
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

A small group of skin cancers of the head and neck, called resected cutaneous squamous carcinomas, are more aggressive than most cancers of this type, even after being treated with standard therapy. This trial will use stronger treatment to look at the safety and effectiveness (efficacy) of combining a drug called Pembrolizumab with radiation after a cancer has already been treated to suppress secondary tumor formation in high risk cutaneous squamous cell cancer of the head and neck. Primary Objective To assess safety by looking at the people with dose limiting responses

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

radiation; resected

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Dose Limiting Toxicities

  There will be an initial safety run in cohort consisting of an initial safety run in cohort consisting of eight patients to allow for at least six evaluable patients for dose limiting toxicities (DLTs) by the week 20 visit. If a total of 0-2 of the initial six evaluable patients experience DLTs, the safety run in will have been deemed successful and the 29 remaining planned patients will be accrued. DLT for this study is defined as the occurrence of a severe adverse event (AE) that is at least possibly related to pembrolizumab, and occurs from the initiation of treatment thru 30 days after the final administration of the study treatment

  Up to 20 weeks post treatment

• Number of Participants With Progression Free Survival

  Progression-free survival (PFS) will be calculated from treatment initiation to disease progression or death from any cause or last follow up

  Up to 1 year after beginning treatment

Study Arms (1)

Pembrolizumab + post operative radiotherapy

EXPERIMENTAL

IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks

Drug: Pembrolizumab; Radiation: IMRT 60-66Gy

Interventions

Pembrolizumab DRUG

200mg every 3 weeks for 16 weeks given by IV infusion

Pembrolizumab + post operative radiotherapy

IMRT 60-66Gy RADIATION

60-66Gy for 6 weeks

Pembrolizumab + post operative radiotherapy

Eligibility Criteria

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

You may qualify if:

• Histologic diagnosis of cutaneous squamous cell carcinoma of the head and neck that has been resected with no evidence of gross residual disease (margin positivity is acceptable)
• Patients must have undergone resection of the disease and demonstrate high risk pathologic features including:
• Node positive disease
• T2/T3N0 disease with any 1 additional feature, including:
• Recurrent Disease
• Perineural invasion
• Lymphovascular space invasion
• Poorly differentiated histology
• Positive Margins
• Satellitosis or in-transit metastases
• Patients are required to have computerized tomography (CT) neck and chest or positron emission tomography/computerized tomography (PET/CT) and have no documented evidence of distant metastases
• Patients must not have a history of the following immunosuppressive conditions:bone marrow transplantation and/or organ transplants and/or chronic rheumatic conditions that require active immunosuppressive therapy. Patients with a history of chronic lymphoid or leukemic malignancies which are not under active therapy (no active therapy within the last 3 months) will be eligible. Patients with chronic lymphoid or leukemic malignancies are eligible with or without active disease as long as they have not had treatment within the past three months.
• Patients may not have had prior therapy with a checkpoint inhibitor (e.g. anti-CTLA-4, anti-PD-1 or anti-PD-L1 therapy)
• Patients may not have had prior radiotherapy (\>30Gy) to the area requiring treatment that would result in any overlap of tissue in both fields
• Patients may have received chemotherapy or radiation for a previous, curatively treated malignancy provided at least 2 years have elapsed and there is no current evidence of disease (patients with previous or concurrent additional skin cancers are eligible)

You may not qualify if:

• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• Has a known history of active Bacillus Tuberculosis (TB)
• Hypersensitivity to pembrolizumab.
• Has a history of the following immunosuppressive conditions: bone marrow transplantation, and/or organ transplants and/or chronic rheumatic conditions that require active immunosuppressive therapy. Patients with chronic lymphoid/leukemic malignancies that have undergone treatment in the last 3 months will be ineligible.
• Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e.≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• Has had prior chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to study Day 1 or who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or a separate primary squamous cell carcinoma of the skin or a separate primary squamous cell carcinoma of the skin. Patients with chronic lymphoid or leukemic malignancies are eligible with or without active disease as long as they have not had treatment within the past three months.
• Has metastatic disease.
• Has known history of, or any evidence of active, non-infectious pneumonitis.
• Has an active infection requiring systemic therapy.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
• Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA is detected).

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (2)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Dr. Shlomo Koyfman
• Organization: Cleveland Clinic, Case Comprehensive Cancer Center

TaussigResearch@ccf.org

1-866-223-8100

Study Officials

• Shlomo Koyfman, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: 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

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 20, 2017
• Study Start: May 10, 2017
• Primary Completion: June 26, 2020
• Study Completion: September 9, 2020
• Last Updated: June 30, 2022
• Results First Posted: October 19, 2020

Record last verified: 2022-06

Locations

US (2)