Pembrolizumab and Radiation for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Not Eligible for Cisplatin Therapy
Overview
- Phase
- Phase 2
- Intervention
- Pembrolizumab
- Conditions
- Head and Neck Cancer
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 29
- Locations
- 3
- Primary Endpoint
- 20 Week Progression Free Survival Rate
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study is being done to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation, for locally advanced squamous cell carcinoma of the head and neck patients who are not good candidates for Cisplatin.
Detailed Description
This open label, phase II trial will enroll 29 subjects in order to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation for locally advanced squamous cell carcinoma head and neck patients who are not good candidates for Cisplatin. Objectives include estimating progression free survival and overall survival, response rates, safety and toxicity, and quality of life in these patients. Correlative studies, based on serial blood collections and tumor samples, may be done under a separate protocol based on availability of archival diagnostic tissue.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be willing and able to provide written informed consent/assent for the trial
- •Be greater than or equal to 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1
- •Histologically or cytologically confirmed stage III-IV (non-metastatic) squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer. Nasopharyngeal cancer patients will be excluded.
- •Ineligible for high dose cisplatin therapy; the reason for ineligibility must be defined.
- •Demonstrate adequate organ function. All screening labs should be performed within 14 days of treatment initiation.
- •No prior curative attempts for this cancer (i.e., surgery, radiation and/or other).
- •Female patients of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. Serum pregnancy test may be required.
- •Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication.
- •Male patients should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Exclusion Criteria
- •If currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
- •Had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent.
- •Has a known additional malignancy that is metastatic, progressing or requires active treatment.
- •Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease even if resolved; patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule.
- •Has clinical or radiologic evidence of interstitial lung disease or active, non-infectious pneumonitis
- •Has an active infection requiring systemic therapy.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Arms & Interventions
Open label
Pembrolizumab
Intervention: Pembrolizumab
Radiation
Intensity Modulated Radiation Therapy (IMRT)
Intervention: Intensity Modulated Radiation Therapy
Outcomes
Primary Outcomes
20 Week Progression Free Survival Rate
Time Frame: 20 weeks after D1 of treatment
the proportion of patients who are alive and free of progression from disease at 20 weeks from the start of treatment
One Year Progression Free Survival Rate
Time Frame: 1 years after D1 of treatment
the proportion of patients who are alive and free of progression from disease atoneyears from the start of treatment
Two Year Progression Free Survival Rate
Time Frame: 2 years after D1 of treatment
the proportion of patients who are alive and free of progression from disease at two years from the start of treatment
Median Progression Free Survival
Time Frame: up to 5 years after D1 of treatment
Progression-free survival is defined as the time from D1 of treatment to progression or death from any cause. The median was not reached, thus Kaplan Meier's estimated rate at 5 years is reported.
Secondary Outcomes
- One Year Overall Survival Rate(1 year after Day 1 of treatment)
- Two Year Overall Survival Rate(2 years after Day 1 of treatment)
- Proportion of Participants Who Received <95% of Intended Dose of Radiation(7 weeks)
- Number of Participants With Clinically Relevant Adverse Events(Monitored continuously from D1 of treatment through 40 weeks.)
- Overall Response Rate(2 years after start of treatment)
- Complete Response Rate(2 years after start of treatment)
- Five Years Locoregional Recurrence Rate(5 years from start of treatment)
- Five Years Distant Metastasis Rate(5 years from start of treatment)
- Quality of Life Measured by Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN)(At baseline, 10 and 20 weeks after initiation of treatment)