NCT02759575

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 head-and-neck-cancer

Timeline
Completed

Started Apr 2016

Typical duration for phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
1 month until next milestone

Results Posted

Study results publicly available

March 12, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

April 26, 2016

Results QC Date

February 18, 2021

Last Update Submit

March 10, 2021

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Treatment-Related Grade 3 or 4 Adverse Events as Assessed by CTCAE V4.0

    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

    30 days following completion of treatment for the first 6 participants

  • Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma

    This is the number of subjects that are laryngectomy-free at 18 months.

    18 months

Secondary Outcomes (1)

  • Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma

    12 months

Study Arms (1)

Pembrolizumab

EXPERIMENTAL

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

Drug: PembrolizumabRadiation: Radiation TherapyDrug: Cisplatin

Interventions

PembrolizumabDRUG

200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses

Also known as: Keytruda
Pembrolizumab
Radiation TherapyRADIATION

70 Gy in 35 fractions over 7 weeks

Pembrolizumab
CisplatinDRUG

100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.

Also known as: Platinol
Pembrolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

  • Frankart AJ, Sadraei NH, Huth B, Redmond KP, Barrett WL, Kurtzweil N, Riaz MK, Wise-Draper T, Rodriguez CP, Adelstein DJ, Takiar V. A phase I/II trial of concurrent immunotherapy with chemoradiation in locally advanced larynx cancer. Laryngoscope Investig Otolaryngol. 2022 Mar 17;7(2):437-443. doi: 10.1002/lio2.780. eCollection 2022 Apr.

    PMID: 35434343DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

pembrolizumabRadiotherapyCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Results Point of Contact

Title
Vinita Takiar, MD, PhD, Associate Professor
Organization
University of Cincinnati
Vinita.Takiar@UCHealth.com
(513)584-8956

Study Officials

  • Vinita Takiar, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Radiation Oncology

Study Record Dates

First Submitted

April 26, 2016

First Posted

May 3, 2016

Study Start

April 1, 2016

Primary Completion

January 24, 2019

Study Completion

February 1, 2021

Last Updated

March 12, 2021

Results First Posted

March 12, 2021

Record last verified: 2021-03

Locations

US(1)