A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma
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| ClinicalTrials.gov Identifier: NCT02759575 |
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Recruitment Status :
Completed
First Posted : May 3, 2016
Results First Posted : March 12, 2021
Last Update Posted : March 12, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Cancer | Drug: Pembrolizumab Radiation: Radiation Therapy Drug: Cisplatin | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 9 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Actual Study Start Date : | April 2016 |
| Actual Primary Completion Date : | January 24, 2019 |
| Actual Study Completion Date : | February 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pembrolizumab
Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
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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.
Other Name: Platinol |
- 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 ]This is the number of subjects that are laryngectomy-free at 18 months.
- Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma [ Time Frame: 12 months ]This is the number of subjects that are laryngectomy-free at 12 months.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759575
| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45219 | |
| Principal Investigator: | Vinita Takiar, MD | University of Cincinnati |
Documents provided by Vinita Takiar, University of Cincinnati:
| Responsible Party: | Vinita Takiar, Assistant Professor of Radiation Oncology, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT02759575 |
| Other Study ID Numbers: |
UCCI-HN-15-02 |
| First Posted: | May 3, 2016 Key Record Dates |
| Results First Posted: | March 12, 2021 |
| Last Update Posted: | March 12, 2021 |
| Last Verified: | March 2021 |
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Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Head and Neck Neoplasms Neoplasms by Site Cisplatin Pembrolizumab Antineoplastic Agents Antineoplastic Agents, Immunological |