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NCT02759575 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2021-03-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma

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outcome · POSTED

Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
    intervention Names
    1. Drug: Pembrolizumab
    2. Radiation: Radiation Therapy
    3. Drug: Cisplatin
    label
    Pembrolizumab
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Pembrolizumab
    description
    200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
    name
    Pembrolizumab
    other Names
    1. Keytruda
    type
    DRUG
  2. arm Group Labels
    1. Pembrolizumab
    description
    70 Gy in 35 fractions over 7 weeks
    name
    Radiation Therapy
    type
    RADIATION
  3. arm Group Labels
    1. Pembrolizumab
    description
    100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
    name
    Cisplatin
    other Names
    1. Platinol
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
9
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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
    measure
    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
  2. description
    This is the number of subjects that are laryngectomy-free at 18 months.
    measure
    Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma
    time Frame
    18 months
secondary Outcomes
  1. description
    This is the number of subjects that are laryngectomy-free at 12 months.
    measure
    Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma
    time Frame
    12 months
Full study description
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.
Source references
references
  1. citation
    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
    35434343
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      requested nct id
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      primary nct id
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      source kind
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      source record id
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      source file sha256
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      payload sha256
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      payload
      clinical indication matching status
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      true
      id
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      link basis
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      nct id
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      occurrences
      1. context exact
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        end
        11
        exact text
        NCT02759575
        start
        0
      offset unit
      unicode_code_points
      query cond
      Laryngeal Cancer
      query disease state id
      ds-laryngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
      source file sha256
      fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
      source json pointer
      /studies/5/protocolSection/identificationModule/nctId
      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
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    Preserved source evidence · Not medical advice