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A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma
This study is currently recruiting participants.
Verified April 2016 by Nooshin Hashemi-Sadraei, University of Cincinnati
Sponsor:
Nooshin Hashemi-Sadraei
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Nooshin Hashemi-Sadraei, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT02759575
First received: April 26, 2016
Last updated: April 29, 2016
Last verified: April 2016
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Purpose
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 cancer. The standard of care treatment will include chemotherapy and radiation for 7 weeks.
| Condition | Intervention | Phase |
|---|---|---|
| Head and Neck Cancer | Drug: Pembrolizumab Radiation: Radiation Therapy Drug: Cisplatin | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of Chemo Radiation Plus the Anti-Programmed Death-1 (Anti-PD-1) Antibody, Pembrolizumab (MK-3475) for Locally Advanced Laryngeal Squamous Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Nooshin Hashemi-Sadraei, University of Cincinnati:
Primary Outcome Measures:
- Number of participants with Treatment-Related Grade 3 or 4 Adverse Events as Assessed by CTCAE V4.0 [ Time Frame: 30 days following completion of treatment for the first 6 participants ]Greater than 2 grade 3 or 4 adverse events that are definitely, probably or possibly related to the pembrolizumab in the first cohort of 6 participants
- Laryngectomy-free survival in locally advanced laryngeal squamous cell carcinoma [ Time Frame: 18 months ]
Secondary Outcome Measures:
- Laryngectomy-free survival in locally advanced laryngeal squamous cell carcinoma [ Time Frame: 12 months ]
| Estimated Enrollment: | 47 |
| Study Start Date: | April 2016 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pembrolizumab
Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
|
Drug: Pembrolizumab
200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
Other Name: Keytruda
Radiation: Radiation Therapy
70 Gy in 35 fractions over 7 weeks
Drug: Cisplatin
100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Biopsy-proven, previously untreated stage III or IV squamous cell carcinoma of the larynx, Primary tumor stage (T2, T3) and nodal stage (N0, N1, N2, N3).
- Measurable disease based on RECIST 1.1.
- Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
- Anticipated survival minimum of 12 months.
- Adequate labs
Exclusion Criteria:
- Patients with T1 primary tumor or T4 large volume tumor that has resulted in larynx dysfunction at baseline (for example tumor largely penetrating into base of tongue and resulting in inability to swallow at baseline)
- Prior radiation therapy to the larynx area or involved neck.
- Distant metastasis
- Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02759575
Please refer to this study by its ClinicalTrials.gov identifier: NCT02759575
Contacts
| Contact: UC Cancer Institute Clinical Trials Office | 513-584-7698 | kastla@ucmail.uc.edu |
Locations
| United States, Ohio | |
| University of Cincinnati Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| Contact: UC Cancer Institute Clinical Trials Office 513-584-7698 kastla@ucmail.uc.edu | |
| Principal Investigator: Nooshin Hashemi, MD | |
Sponsors and Collaborators
Nooshin Hashemi-Sadraei
Merck Sharp & Dohme Corp.
Investigators
| Principal Investigator: | Nooshin Hashemi, MD | University of Cincinnati |
More Information
| Responsible Party: | Nooshin Hashemi-Sadraei, Assistant Professor of Medicine, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT02759575 History of Changes |
| Other Study ID Numbers: |
UCCI-HN-15-02 |
| Study First Received: | April 26, 2016 |
| Last Updated: | April 29, 2016 |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Neoplasms by Site Pembrolizumab Cisplatin Antineoplastic Agents |
ClinicalTrials.gov processed this record on July 17, 2017