Description:
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.
Title
- Brief Title: A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma
- 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
Clinical Trial IDs
- ORG STUDY ID:
UCCI-HN-15-02
- NCT ID:
NCT02759575
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Pembrolizumab | Keytruda | Pembrolizumab |
| Cisplatin | Platinol | Pembrolizumab |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Pembrolizumab | Experimental | Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| 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 |
| Safety Issue: | |
| 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 |
Secondary Outcome Measures
| Measure: | Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma |
| Time Frame: | 12 months |
| Safety Issue: | |
| Description: | This is the number of subjects that are laryngectomy-free at 12 months. |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Vinita Takiar |
Last Updated
March 12, 2021
