A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma

This study is currently recruiting participants.

See

Contacts and Locations

Verified April 2016 by Nooshin Hashemi-Sadraei, University of Cincinnati

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 26, 2016

Last Updated Date

April 29, 2016

Start Date ^ICMJE

April 2016

Estimated Primary Completion Date

January 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Laryngectomy-free survival in locally advanced laryngeal squamous cell carcinoma [ Time Frame: 12 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma

Official Title ^ICMJE

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

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 cancer. The standard of care treatment will include chemotherapy and radiation for 7 weeks.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

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.

Study Arms

Experimental: Pembrolizumab

Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin

Interventions:

Drug: Pembrolizumab
Radiation: Radiation Therapy
Drug: Cisplatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2018

Estimated Primary Completion Date

January 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: UC Cancer Institute Clinical Trials Office

513-584-7698

kastla@ucmail.uc.edu

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02759575

Other Study ID Numbers ^ICMJE

UCCI-HN-15-02

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Nooshin Hashemi-Sadraei, University of Cincinnati

Study Sponsor ^ICMJE

Nooshin Hashemi-Sadraei

Collaborators ^ICMJE

Merck Sharp & Dohme Corp.

Investigators ^ICMJE

Principal Investigator:

Nooshin Hashemi, MD

University of Cincinnati

PRS Account

University of Cincinnati

Verification Date

April 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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