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

NCT ID: NCT02759575

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2021-02-28

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.

Detailed Description

This study is an open label, single arm study which will enroll patients with locally advanced squamous cell carcinomas of the larynx. Positive tumor PDL1 expression by IHC will not be required for enrollment.

All patients with receive Pembrolizumab and cisplatin in combination with radiation. Pembrolizumab 200 mg flat dose given Q21 days will begin 3 weeks prior to initiation of chemoradiation and continued through the 21-day cycle until completion of chemoradiation. Cisplatin will be given 100 mg/m2 every 21 days during radiation as per standard of care.

Pembrolizumab has well defined toxicities as single agent and has non-overlapping mechanisms of action with cisplatin and radiation. The safety of these agents used in combination has not been previously described, therefore the study will begin with a safety run-in phase 1 followed by the phase II design. See statistical section for details.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pembrolizumab

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

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

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

Radiation Therapy

Intervention Type: RADIATION

70 Gy in 35 fractions over 7 weeks

Cisplatin

Intervention Type: DRUG

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

Interventions

Pembrolizumab

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

Intervention Type: DRUG

Radiation Therapy

70 Gy in 35 fractions over 7 weeks

Intervention Type: RADIATION

Cisplatin

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

Intervention Type: DRUG

Other Intervention Names

Keytruda; Platinol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Vinita Takiar

OTHER

Sponsor Role: lead

Responsible Party

Vinita Takiar

Assistant Professor of Radiation Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vinita Takiar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35434343 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UCCI-HN-15-02

Identifier Type: -

Identifier Source: org_study_id