Pembrolizumab + Radiation for Locally Adv SCC of the Head and Neck (SCCHN) Not Eligible Cisplatin

• Sponsor: UNC Lineberger Comprehensive Cancer Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02609503
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 29
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 86.4
• Patients Per Site: 9.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: Pembrolizumab; Radiation: Intensity Modulated Radiation Therapy	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pembrolizumab and Radiation for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Not Eligible for Cisplatin Therapy
• Actual Study Start Date: May 16, 2016
• Anticipated Primary Completion Date: Jul 30, 2023
• Anticipated Study Completion Date: Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open label Pembrolizumab	Drug: Pembrolizumab; Pembrolizumab, 200 mg IV during cycle visits every 3-weeks for up to 6 cycles, or until toxicities are no longer tolerable; Other Names: Keytruda
Other: Radiation Intensity Modulated Radiation Therapy (IMRT)	Radiation: Intensity Modulated Radiation Therapy; Eligible participants will receive Intensity Modulated Radiation Therapy daily x 7 weeks; Other Names: IMRT

Outcome Measures

Primary Outcome Measures

1. 20 Week Progression Free Survival Rate [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

2. One Year Progression Free Survival Rate [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

3. Two Year Progression Free Survival Rate [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

4. Median Progression Free Survival [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.

Secondary Outcome Measures

1. One Year Overall Survival Rate [1 year after Day 1 of treatment]

   the proportion of patients who are alive at one year after Day 1 of treatment

2. Two Year Overall Survival Rate [2 years after Day 1 of treatment]

   the proportion of patients who are alive at two years after Day 1 of treatment

3. Proportion of Participants Who Received <95% of Intended Dose of Radiation [7 weeks]

   Evaluate the safety of the proposed regimen by Estimating the proportion of patients who receive <95% of the intended dose of radiation (i.e., <67 Gray)

4. Number of Participants With Clinically Relevant Adverse Events [Monitored continuously from D1 of treatment through 40 weeks.]

   Safety was assessed by documenting clinically relevant adverse events, defined as events reported by both the clinician and participant related to concurrent radiation plus pembrolizumab. Clinicians classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). The grading (severity) scale for each AE term: Grade (G) 1 Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; G 2 Moderate; G 3 Severe or medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated; disabling; G 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Patient assessed toxicity were classified based on the Patient-Reported Outcome version of the CTCAE (PRO-CTCAE) which measures the severity, interference, and frequency of events on a 5 point likert scale (0-4) with a higher score indicating worse or more bothersome event

5. Overall Response Rate [2 years after start of treatment]

   Overall response rate will be determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) which defines Complete Response (CR) as Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Overall Response Rate (ORR) = CR + PR/total number of subjects.

6. Complete Response Rate [2 years after start of treatment]

   complete response rate will be determined using RECIST 1.1 and is defined as the percentage of participants who achieve a Complete response (CR)-Disappearance of all target lesions. Any pathological lymph node (LN) (whether target or non-target) must have decreased in short axis to <10mm.

7. Time to Locoregional Recurrence [5 years from start of treatment]

   Time to locoregional recurrence is defined from Day 1 of treatment until the first locoregional progression

8. Time to Distant Metastasis [5 years from start of treatment]

   Time to distant metastasis is defined as the time from day 1 of treatment to progression of disease at a distant site; deaths or other progressions will be censored

9. 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]

   The FACT-HN is the FACT-General (FACT-G) and a head and neck cancer specific (HNC) subscale given at baseline, at end of treatment, and at first follow-up visit. The FACT-G is a measure of general QOL with Items rated by patients on a Likert scale from 0 to 4, assessing function in 4 domains: physical well-being (PWB) (7 items, score range 0-28), social-family well-being (SFWB) (7 items, score range 0-28), emotional well-being (EWB) (6 items, score range 0-24) and functional well-being (FWB) (7 items, score range 0-28). The HNC subscale has 12 items and a score range from 0 to 48. Higher scores represent better QOL.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

• As determined by the enrolling physician or protocol designee, ability of the patient to understand and comply with study procedures for the entire length of the study.

• Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment.

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.

• Has inadequate home environment or social support to safely complete the trial procedures.

• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

• Has received prior therapy with an anti-programmed cell death (PD-1), anti-PD-L1, anti-PD-L1, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.

• Has a known history of Human Immunodeficiency Virus (HIV) HIV 1/2 antibodies) Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C )e.g., HCV RNA [qualitative] is detected).

• Has received a live vaccine within 30 days prior to the first dose of trial treatment.

• Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland	United States	21231
2	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	United States	27599
3	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111

Sponsors and Collaborators

• UNC Lineberger Comprehensive Cancer Center
• Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: Jared Weiss, MD, UNC Lineberger Comprehensive Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 2, 2016

More Information

Additional Information:

• UNC Lineberger Comprehensive Cancer Center

Publications

None provided.

• Responsible Party: UNC Lineberger Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02609503
• Other Study ID Numbers: LCCC 1509
• First Posted: Nov 20, 2015
• Last Update Posted: Dec 8, 2021
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Head and Neck Neoplasms; Pembrolizumab

Study Results

Participant Flow

Recruitment Details	Participants were recruited from the University of North Carolina (Chapel Hill, NC), Fox Chase Cancer Center (Philadelphia, PA), and Johns Hopkins (Baltimore,MD) between February 2016 and July 2018.
Pre-assignment Detail	One potential participant was deemed ineligible during screening and therefore did not start the trial.

Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Period Title: Overall Study
STARTED	29
COMPLETED	25
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Overall Participants	29
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	63.1
Sex: Female, Male (Count of Participants)
Female	1 3.4%
Male	28 96.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.4%
Not Hispanic or Latino	28 96.6%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 3.4%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	25 86.2%
More than one race	0 0%
Unknown or Not Reported	3 10.3%
Region of Enrollment (participants) [Number]
United States	29 100%
Smoking status (Count of Participants)
Current	3 10.3%
Former	15 51.7%
Never	11 37.9%
Smoking pack years (Count of Participants)
<10 pack years	13 44.8%
>=10 pack years	16 55.2%
Performance status (Count of Participants)
0	12 41.4%
1	17 58.6%
Reason for cisplatin ineligibility (Count of Participants)
Hearing	14 48.3%
Tinnitus	6 20.7%
Renal function	5 17.2%
Diabetes	2 6.9%
Neuropathy	2 6.9%
Charleson comorbidity index score (Count of Participants)
0	6 20.7%
1	6 20.7%
2	11 37.9%
3	2 6.9%
4	3 10.3%
5	1 3.4%
Primary site (Count of Participants)
Base of tongue	10 34.5%
Tonsil	10 34.5%
Supraglottic larynx	3 10.3%
Hypopharynx	2 6.9%
Unknown primary	2 6.9%
Oral tongue	1 3.4%
Uvula	1 3.4%
Stage (Count of Participants)
I	5 17.2%
II	3 10.3%
III	11 37.9%
IVA	8 27.6%
IVB	2 6.9%
Programmed cell Death Ligand-1 (PD-L1) Modified Percent Score (MPS) (percent staining) [Median (Full Range) ]
Median (Full Range) [percent staining]	60
Programmed cell Death Ligand-1 (PD-L1) modified H-score (MHS) (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	105
Tumor-Infiltrating Lymphocytes (TIL) (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	3

Outcome Measures

1. Primary Outcome

Title	20 Week Progression Free Survival Rate
Description	the proportion of patients who are alive and free of progression from disease at 20 weeks from the start of treatment
Time Frame	20 weeks after D1 of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Measure Participants	29
Number (95% Confidence Interval) [proportion of participants]	0.90 3.1%

2. Primary Outcome

Title	One Year Progression Free Survival Rate
Description	the proportion of patients who are alive and free of progression from disease atoneyears from the start of treatment
Time Frame	1 years after D1 of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Measure Participants	29
Number (95% Confidence Interval) [proportion of participants]	0.76 2.6%

3. Primary Outcome

Title	Two Year Progression Free Survival Rate
Description	the proportion of patients who are alive and free of progression from disease at two years from the start of treatment
Time Frame	2 years after D1 of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Measure Participants	29
Number (95% Confidence Interval) [proportion of participants]	0.71 2.4%

4. Primary Outcome

Title	Median Progression Free Survival
Description	Progression Free survival is defined as the time from D1 of treatment to progression or death from any cause.
Time Frame	up to 5 years after D1 of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	One Year Overall Survival Rate
Description	the proportion of patients who are alive at one year after Day 1 of treatment
Time Frame	1 year after Day 1 of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Measure Participants	29
Number (95% Confidence Interval) [proportion of participants]	0.86 3%

6. Secondary Outcome

Title	Two Year Overall Survival Rate
Description	the proportion of patients who are alive at two years after Day 1 of treatment
Time Frame	2 years after Day 1 of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Measure Participants	29
Number (95% Confidence Interval) [proportion of participants]	0.75 2.6%

7. Secondary Outcome

Title	Proportion of Participants Who Received <95% of Intended Dose of Radiation
Description	Evaluate the safety of the proposed regimen by Estimating the proportion of patients who receive <95% of the intended dose of radiation (i.e., <67 Gray)
Time Frame	7 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Measure Participants	29
Number [proportion of participants]	0 0%

8. Secondary Outcome

Title	Number of Participants With Clinically Relevant Adverse Events
Description	Safety was assessed by documenting clinically relevant adverse events, defined as events reported by both the clinician and participant related to concurrent radiation plus pembrolizumab. Clinicians classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). The grading (severity) scale for each AE term: Grade (G) 1 Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; G 2 Moderate; G 3 Severe or medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated; disabling; G 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Patient assessed toxicity were classified based on the Patient-Reported Outcome version of the CTCAE (PRO-CTCAE) which measures the severity, interference, and frequency of events on a 5 point likert scale (0-4) with a higher score indicating worse or more bothersome event
Time Frame	Monitored continuously from D1 of treatment through 40 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Measure Participants	29
Pain	10 34.5%
Decreased appetite	5 17.2%
Swallowing difficulty	12 41.4%
Dry mouth	24 82.8%
Fatigue	18 62.1%

9. Secondary Outcome

Title	Overall Response Rate
Description	Overall response rate will be determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) which defines Complete Response (CR) as Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Overall Response Rate (ORR) = CR + PR/total number of subjects.
Time Frame	2 years after start of treatment

Outcome Measure Data

Analysis Population Description

Two participants did not complete follow-up radiographic measurements to assess for response

Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Measure Participants	27
Count of Participants [Participants]	26 89.7%

10. Secondary Outcome

Title	Complete Response Rate
Description	complete response rate will be determined using RECIST 1.1 and is defined as the percentage of participants who achieve a Complete response (CR)-Disappearance of all target lesions. Any pathological lymph node (LN) (whether target or non-target) must have decreased in short axis to <10mm.
Time Frame	2 years after start of treatment

Outcome Measure Data

Analysis Population Description

Two participants did not complete follow-up radiographic measurements to assess for response

Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Measure Participants	27
Count of Participants [Participants]	23 79.3%

11. Secondary Outcome

Title	Time to Locoregional Recurrence
Description	Time to locoregional recurrence is defined from Day 1 of treatment until the first locoregional progression
Time Frame	5 years from start of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Time to Distant Metastasis
Description	Time to distant metastasis is defined as the time from day 1 of treatment to progression of disease at a distant site; deaths or other progressions will be censored
Time Frame	5 years from start of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Secondary Outcome

Title	Quality of Life Measured by Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN)
Description	The FACT-HN is the FACT-General (FACT-G) and a head and neck cancer specific (HNC) subscale given at baseline, at end of treatment, and at first follow-up visit. The FACT-G is a measure of general QOL with Items rated by patients on a Likert scale from 0 to 4, assessing function in 4 domains: physical well-being (PWB) (7 items, score range 0-28), social-family well-being (SFWB) (7 items, score range 0-28), emotional well-being (EWB) (6 items, score range 0-24) and functional well-being (FWB) (7 items, score range 0-28). The HNC subscale has 12 items and a score range from 0 to 48. Higher scores represent better QOL.
Time Frame	At baseline, 10 and 20 weeks after initiation of treatment

Outcome Measure Data

Analysis Population Description

Three subjects did not complete the FACT assessments and are therefore not included

Arm/Group Title	Baseline Assessment - Pembrolizumab Concomitant With and Post 7 Weeks of Radiation	Week 10 Assessment - Pembrolizumab Concomitant With and Post 7 Weeks of Radiation	Week 20 Assessment - Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	Baseline Quality of life Measurements All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.	Week 10 Quality of life Measurements All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.	Week 20 Quality of life Measurements All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
Measure Participants	26	26	26
PWB	23.26	17.63	19.81
SFWB	22.26	21.54	23.40
EWB	18.12	17.85	17.59
FWB	19.00	14.04	16.74
HNC	24.57	14.75	18.92

Adverse Events

Time Frame	From day 1 of treatment up to 40 weeks after the end of treatment
Arm/Group Title	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
Arm/Group Description	All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT) as per standard of care. The total dose will be 70 Gray(Gy) at 2Gy/fraction, 35 fractions, Monday to Friday, for 7 weeks. Starting on the first day of radiotherapy, patients will be treated with pembrolizumab 200 milligrams (mg) intravenous (IV) every 3 weeks for 6 doses.
All Cause Mortality
	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
	Affected / at Risk (%)	# Events
Total	7/29 (24.1%)
Serious Adverse Events
	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
	Affected / at Risk (%)	# Events
Total	6/29 (20.7%)
Gastrointestinal disorders
Constipation	2/29 (6.9%)
Dysphagia	1/29 (3.4%)
Esophagitis	1/29 (3.4%)
General disorders
Fever	1/29 (3.4%)
Hepatobiliary disorders
Cholecystitis	1/29 (3.4%)
Investigations
Weight loss	1/29 (3.4%)
Metabolism and nutrition disorders
Dehydration	1/29 (3.4%)
Hyponatremia	1/29 (3.4%)
Musculoskeletal and connective tissue disorders
Generalized muscle weakness	1/29 (3.4%)
Psychiatric disorders
Confusion	1/29 (3.4%)
Renal and urinary disorders
Urinary retention	1/29 (3.4%)
Respiratory, thoracic and mediastinal disorders
Aspiration	1/29 (3.4%)
Other (Not Including Serious) Adverse Events
	Pembrolizumab Concomitant With and Post 7 Weeks of Radiation
	Affected / at Risk (%)	# Events
Total	29/29 (100%)
Blood and lymphatic system disorders
Anemia	13/29 (44.8%)
Lymph node pain	1/29 (3.4%)
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify	1/29 (3.4%)
Ear pain	2/29 (6.9%)
Tinnitus	1/29 (3.4%)
Endocrine disorders
Hypothyroidism	2/29 (6.9%)
Eye disorders
Blurred vision	2/29 (6.9%)
Eye disorders - Other, specify	1/29 (3.4%)
Gastrointestinal disorders
Abdominal pain	1/29 (3.4%)
Constipation	21/29 (72.4%)
Diarrhea	5/29 (17.2%)
Dry mouth	24/29 (82.8%)
Dysphagia	11/29 (37.9%)
Gastroesophageal reflux disease	4/29 (13.8%)
Mucositis oral	24/29 (82.8%)
Nausea	16/29 (55.2%)
Oral pain	4/29 (13.8%)
Vomiting	3/29 (10.3%)
General disorders
Chills	4/29 (13.8%)
Edema limbs	2/29 (6.9%)
Fatigue	19/29 (65.5%)
Fever	3/29 (10.3%)
Flu like symptoms	1/29 (3.4%)
Neck edema	1/29 (3.4%)
Non-cardiac chest pain	1/29 (3.4%)
Pain	4/29 (13.8%)
Immune system disorders
Allergic reaction	1/29 (3.4%)
Infections and infestations
Bronchial infection	1/29 (3.4%)
Mucosal infection	7/29 (24.1%)
Papulopustular rash	1/29 (3.4%)
Salivary gland infection	1/29 (3.4%)
Tooth infection	1/29 (3.4%)
Upper respiratory infection	1/29 (3.4%)
Injury, poisoning and procedural complications
Dermatitis radiation	24/29 (82.8%)
Fall	1/29 (3.4%)
Tracheal hemorrhage	1/29 (3.4%)
Investigations
Alanine aminotransferase increased	5/29 (17.2%)
Alkaline phosphatase increased	4/29 (13.8%)
Aspartate aminotransferase increased	5/29 (17.2%)
Blood bilirubin increased	8/29 (27.6%)
Creatinine increased	3/29 (10.3%)
Lymphocyte count decreased	26/29 (89.7%)
Neutrophil count decreased	3/29 (10.3%)
Platelet count decreased	4/29 (13.8%)
Weight gain	1/29 (3.4%)
Weight loss	25/29 (86.2%)
White blood cell decreased	12/29 (41.4%)
Metabolism and nutrition disorders
Anorexia	5/29 (17.2%)
Dehydration	4/29 (13.8%)
Hypercalcemia	3/29 (10.3%)
Hyperglycemia	2/29 (6.9%)
Hyperkalemia	3/29 (10.3%)
Hypermagnesemia	4/29 (13.8%)
Hypoalbuminemia	9/29 (31%)
Hypocalcemia	3/29 (10.3%)
Hypoglycemia	2/29 (6.9%)
Hypokalemia	3/29 (10.3%)
Hypomagnesemia	2/29 (6.9%)
Hyponatremia	4/29 (13.8%)
Musculoskeletal and connective tissue disorders
Arthritis	2/29 (6.9%)
Back pain	1/29 (3.4%)
Myalgia	1/29 (3.4%)
Trismus	1/29 (3.4%)
Nervous system disorders
Dizziness	1/29 (3.4%)
Dysgeusia	24/29 (82.8%)
Dysphasia	1/29 (3.4%)
Headache	3/29 (10.3%)
Memory impairment	1/29 (3.4%)
Nervous system disorders - Other, specify	2/29 (6.9%)
Paresthesia	1/29 (3.4%)
Tremor	2/29 (6.9%)
Psychiatric disorders
Anxiety	3/29 (10.3%)
Depression	2/29 (6.9%)
Insomnia	4/29 (13.8%)
Renal and urinary disorders
Acute kidney injury	1/29 (3.4%)
Urinary retention	1/29 (3.4%)
Respiratory, thoracic and mediastinal disorders
Cough	7/29 (24.1%)
Dyspnea	1/29 (3.4%)
Hoarseness	3/29 (10.3%)
Laryngeal edema	2/29 (6.9%)
Laryngeal hemorrhage	5/29 (17.2%)
Respiratory, thoracic and mediastinal disorders - Other, specify	1/29 (3.4%)
Sneezing	1/29 (3.4%)
Sore throat	10/29 (34.5%)
Voice alteration	1/29 (3.4%)
Skin and subcutaneous tissue disorders
Alopecia	1/29 (3.4%)
Dry skin	2/29 (6.9%)
Hyperhidrosis	1/29 (3.4%)
Pruritus	3/29 (10.3%)
Rash maculo-papular	10/29 (34.5%)
Skin and subcutaneous tissue disorders - Other, specify	1/29 (3.4%)
Skin hyperpigmentation	1/29 (3.4%)
Surgical and medical procedures
Surgical and medical procedures - Other, specify	1/29 (3.4%)
Vascular disorders
Hypotension	1/29 (3.4%)
Lymphedema	3/29 (10.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.