Carcinoma, Squamous Cell of Head and Neck, Recurrent Head and Neck Cancer
Conditions
Keywords
head and neck cancer, reirradiation, MK-3475, Anti-PD-1 monoclonal antibody, Squamous cell carcinoma, Keytruda, pembrolizumab
Brief summary
Eligible participants with locoregional inoperable recurrence or second primary squamous cell carcinoma of the head and neck will be treated with reirradiation combined with anti-PD-1 mAb MK-3475 (generic name: pembrolizumab, trade name Keytruda®).
Detailed description
Each participant will undergo screening and then be treated with reirradiation with 1.2 Gy BID, 5 days a week (weeks 1-5). MK-3475 (generic name: pembrolizumab, trade name Keytruda®) will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued in all participants until 3 months post completion of reirradiation, at which time a PET/CT will be done to evaluate response. Participants with progressive disease (PD) will be taken off MK-3475 and followed for survival. Participants that have a complete response (CR) will be followed clinically and radiographically, and if disease recurs may be eligible to be retreated with MK-3475 for up to one year. Participants with partial response (PR) or stable disease (SD) will continue treatment with MK-3475 for up to two years unless one of the following occurs: * documented disease progression * unacceptable adverse event(s) * intercurrent illness that prevents further administration of treatment * investigator decision to withdraw the subject * withdrawal of consent * pregnancy * noncompliance * administrative reasons (i.e. trial is closed prematurely). Participants who have not progressed at completion of 24 months of therapy will be observed, but may be eligible for 1 year of retreatment with MK-3475 if they develop recurrence/progression and qualify for retreatment as detailed in the protocol,and if the trial is still ongoing.
Interventions
RADIATIONReirradiation
Reirradiation 1.2 GY BID 5 days a week for 5 weeks.
DRUGMK-3475
MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Sponsors
Merck Sharp & Dohme LLC
Dan Zandberg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with biopsy proven locoregional recurrence or second primary SCCHN which is unresectable or the patient is unwilling to undergo resection. Determination of unresectability will be based on multidisciplinary review of each case. Inclusion Criteria: 1. Have received only prior radiation treatment course. Prior radiation course must have been with curative intent. 2. At least 6 months since completion of radiation 3. Based on prior radiation records, have had most of the tumor volume (\>50%) previously radiated at doses \> 45 Gy without exceeding spinal cord tolerance (combining previous and future radiation dose to spinal cord of \< 50 Gy). 4. Be willing to undergo percutaneous endoscopic gastrostomy (PEG) placement, if necessary. 5. Have at least one measurable area of disease based on RECIST 1.1 within the previously radiated field. 6. Have provided adequate tissue for PD-L1 analysis either from an archival tissue sample or fresh biopsy done to confirm recurrence/second primary. Archival tissue sample can only be used if done within 3 months of enrollment on the clinical trial. 7. Performance status of 0 or 1 on the ECOG Performance Scale. 8. Life expectancy greater than 12 weeks 9. Adequate organ function as defined by the protocol
Exclusion criteria
1. Presence of distant metastatic disease. 2. Is currently participating in or has participated in a study of an investigational agent or used an investigational device within 4 weeks of the first dose of treatment. 3. 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. 4. Has had a prior monoclonal antibody, chemotherapy, or targeted small molecule therapy 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. 5. History of other malignancy within 5 years with the exception of prior Squamous cell carcinoma of the head and neck, adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervix. 6. Has an active autoimmune disease 7. Has evidence of interstitial lung disease or active, non-infectious pneumonitis. 8. Has an active infection requiring systemic therapy 9. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). 10. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 11. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). 12. Has received a live vaccine within 30 days prior to the first dose of trial treatment 13. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | Up to 36 months (after starting reirradiation and MK-3475) | Number of months from the date of initiation of treatment to the date of progression of disease or death (whichever occurs first). Progressive disease, per RECIST 1.1, is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Benefit Rate (CBR) | Up to 36 months (after initiation of treatment with reirradiation and MK-3475) | The percentage of patients that have achieved a complete response, partial response, and stable disease as defined by RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Time to in Field Disease Progression | Up to 36 months (after initiation of treatment with reirradiation and MK-3475) | Number of months from initiation of treatment to progression of disease within the radiation field.Progressive disease, per RECIST 1.1, is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Overall Survival (OS) | Up to 36 months (after initiation of treatment with reirradiation and MK-3475) | Number of months from first treatment until death. Patients who are alive will be censored at the last date of patient contact. |
| Quality of Life Using EORTC QLQ-C30 - Baseline | At Baseline | Patient reported outcomes will be measured using EORTC QLQ-C30 questionnaires. This tool contains 30 items. It measures 5 functional dimensions (physical, role, cognitive, social, emotional), 6 single items (appetite loss, constipation, dyspnea, financial impact, sleep disturbance, diarrhea), 3 symptom items (fatigue, pain, nausea/vomiting) and a global health and quality of life scale. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. |
| Quality of Life Using EORTC QLQ-C30 - Cycle 3 | At Cycle 3 (Week 6) | Patient reported outcomes will be measured using EORTC QLQ-C30 questionnaires. This tool contains 30 items. It measures 5 functional dimensions (physical, role, cognitive, social, emotional), 6 single items (appetite loss, constipation, dyspnea, financial impact, sleep disturbance, diarrhea), 3 symptom items (fatigue, pain, nausea/vomiting) and a global health and quality of life scale. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. |
| Quality of Life Using EORTC QLQ-C30 - Cycle 9 | At Cycle 9 (Week 26) | Patient reported outcomes will be measured using EORTC QLQ-C30 questionnaires. This tool contains 30 items. It measures 5 functional dimensions (physical, role, cognitive, social, emotional), 6 single items (appetite loss, constipation, dyspnea, financial impact, sleep disturbance, diarrhea), 3 symptom items (fatigue, pain, nausea/vomiting) and a global health and quality of life scale. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. |
| Best Overall Response Rate (ORR) | Up to 36 months (after initiation of treatment with reirradiation and MK-3475) | The percentage of the patients who have either Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, or, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The patient's best overall response rate defined as the best response recorded from the start of the treatment until disease progression will be recorded, per RECIST 1.1. |
| Quality of Life Using EORTC QLQ-C30 - 36 Months | At 36 months | Patient reported outcomes will be measured using EORTC QLQ-C30 questionnaires. This tool contains 30 items. It measures 5 functional dimensions (physical, role, cognitive, social, emotional), 6 single items (appetite loss, constipation, dyspnea, financial impact, sleep disturbance, diarrhea), 3 symptom items (fatigue, pain, nausea/vomiting) and a global health and quality of life scale. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. |
| Quality of Life Using EORTC QLQ-H&N 35 - Baseline | At Baseline | Patient reported outcomes will be measured using the EORTC QLQ-H&N35, a 35-item questionnaire that assesses symptoms encountered specifically by patients with head and neck cancer. This measure generates 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc). Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. |
| Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | At Cycle 3 (Week 6) | Patient reported outcomes will be measured using the EORTC QLQ-H&N35, a 35-item questionnaire that assesses symptoms encountered specifically by patients with head and neck cancer. This measure generates 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc). Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. |
| Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | At Cycle 9 (Week 26) | Patient reported outcomes will be measured using the EORTC QLQ-H&N35, a 35-item questionnaire that assesses symptoms encountered specifically by patients with head and neck cancer. This measure generates 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc). Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. |
| Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | At 12 months | Patient reported outcomes will be measured using the EORTC QLQ-H&N35, a 35-item questionnaire that assesses symptoms encountered specifically by patients with head and neck cancer. This measure generates 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc). Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. |
| Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | At 36 months | Patient reported outcomes will be measured using the EORTC QLQ-H&N35, a 35-item questionnaire that assesses symptoms encountered specifically by patients with head and neck cancer. This measure generates 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc). Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. |
| Quality of Life Using EORTC QLQ-C30 - 12 Months | At 12 months | Patient reported outcomes will be measured using EORTC QLQ-C30 questionnaires. This tool contains 30 items. It measures 5 functional dimensions (physical, role, cognitive, social, emotional), 6 single items (appetite loss, constipation, dyspnea, financial impact, sleep disturbance, diarrhea), 3 symptom items (fatigue, pain, nausea/vomiting) and a global health and quality of life scale. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reirradiation + MK-3475 Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation.
Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks.
MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Reirradiation + MK-3475 |
|---|---|
| Age, Continuous | 64.17 years STANDARD_DEVIATION 8.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 37 / 48 |
| other Total, other adverse events | 46 / 48 |
| serious Total, serious adverse events | 27 / 48 |
Outcome results
Primary
Progression Free Survival
Number of months from the date of initiation of treatment to the date of progression of disease or death (whichever occurs first). Progressive disease, per RECIST 1.1, is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: Up to 36 months (after starting reirradiation and MK-3475)
Population: All treated patients who were radiologically evaluable and experienced disease progression.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reirradiation + MK-3475 | Progression Free Survival | 7.9 months |
Secondary
Best Overall Response Rate (ORR)
The percentage of the patients who have either Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, or, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The patient's best overall response rate defined as the best response recorded from the start of the treatment until disease progression will be recorded, per RECIST 1.1.
Time frame: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)
Population: All treated patients who achieved radiologic response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reirradiation + MK-3475 | Best Overall Response Rate (ORR) | 56.1 percentage of patients |
Secondary
Clinical Benefit Rate (CBR)
The percentage of patients that have achieved a complete response, partial response, and stable disease as defined by RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)
Population: All treated patients who achieved radiologic response or stable disease.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reirradiation + MK-3475 | Clinical Benefit Rate (CBR) | 78.0 percentage of participants |
Secondary
Overall Survival (OS)
Number of months from first treatment until death. Patients who are alive will be censored at the last date of patient contact.
Time frame: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)
Population: All patients enrolled in the trial.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reirradiation + MK-3475 | Overall Survival (OS) | 13.1 months |
Secondary
Quality of Life Using EORTC QLQ-C30 - 12 Months
Patient reported outcomes will be measured using EORTC QLQ-C30 questionnaires. This tool contains 30 items. It measures 5 functional dimensions (physical, role, cognitive, social, emotional), 6 single items (appetite loss, constipation, dyspnea, financial impact, sleep disturbance, diarrhea), 3 symptom items (fatigue, pain, nausea/vomiting) and a global health and quality of life scale. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: At 12 months
Population: Treated patients who completed Quality of Life evaluations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Global Health Status | 72.50 score on a scale | Standard Deviation 16.69 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Physical Functioning | 84.67 score on a scale | Standard Deviation 16.94 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Role Functioning | 85.00 score on a scale | Standard Deviation 16.57 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Emotional Functioning | 85.00 score on a scale | Standard Deviation 16.57 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Cognitive Functioning | 91.67 score on a scale | Standard Deviation 14.16 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Social Functioning | 86.67 score on a scale | Standard Deviation 23.31 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Fatigue | 14.44 score on a scale | Standard Deviation 17.41 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Nausea and Vomiting | 0.00 score on a scale | Standard Deviation 0 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Pain | 26.67 score on a scale | Standard Deviation 22.5 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Dyspnea | 6.67 score on a scale | Standard Deviation 21.08 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Insomnia | 6.67 score on a scale | Standard Deviation 21.08 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Appetite Loss | 20.00 score on a scale | Standard Deviation 23.31 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Constipation | 3.33 score on a scale | Standard Deviation 10.54 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Diarrhea | 3.33 score on a scale | Standard Deviation 10.54 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 12 Months | Financial concerns | 16.67 score on a scale | Standard Deviation 28.33 |
Secondary
Quality of Life Using EORTC QLQ-C30 - 36 Months
Patient reported outcomes will be measured using EORTC QLQ-C30 questionnaires. This tool contains 30 items. It measures 5 functional dimensions (physical, role, cognitive, social, emotional), 6 single items (appetite loss, constipation, dyspnea, financial impact, sleep disturbance, diarrhea), 3 symptom items (fatigue, pain, nausea/vomiting) and a global health and quality of life scale. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: At 36 months
Population: Treated patients who completed Quality of Life evaluations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Global Health Status | 75.00 score on a scale | Standard Deviation 22.05 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Physical Functioning | 95.56 score on a scale | Standard Deviation 3.85 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Role Functioning | 88.89 score on a scale | Standard Deviation 19.25 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Emotional Functioning | 88.89 score on a scale | Standard Deviation 12.73 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Cognitive Functioning | 94.44 score on a scale | Standard Deviation 9.62 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Social Functioning | 66.67 score on a scale | Standard Deviation 57.74 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Fatigue | 11.11 score on a scale | Standard Deviation 19.25 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Nausea and Vomiting | 0.00 score on a scale | Standard Deviation 0 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Pain | 5.56 score on a scale | Standard Deviation 9.62 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Dyspnea | 0.00 score on a scale | Standard Deviation 0 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Insomnia | 11.11 score on a scale | Standard Deviation 19.25 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Appetite Loss | 11.11 score on a scale | Standard Deviation 19.25 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Constipation | 11.11 score on a scale | Standard Deviation 19.25 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Diarrhea | 0.00 score on a scale | Standard Deviation 0 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - 36 Months | Financial concerns | 33.33 score on a scale | Standard Deviation 57.74 |
Secondary
Quality of Life Using EORTC QLQ-C30 - Baseline
Patient reported outcomes will be measured using EORTC QLQ-C30 questionnaires. This tool contains 30 items. It measures 5 functional dimensions (physical, role, cognitive, social, emotional), 6 single items (appetite loss, constipation, dyspnea, financial impact, sleep disturbance, diarrhea), 3 symptom items (fatigue, pain, nausea/vomiting) and a global health and quality of life scale. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: At Baseline
Population: Treated patients who completed Quality of Life evaluations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Global Health Status | 58.33 score on a scale | Standard Deviation 24.06 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Physical Functioning | 77.69 score on a scale | Standard Deviation 24.55 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Role Functioning | 66.33 score on a scale | Standard Deviation 30.9 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Emotional Functioning | 71.53 score on a scale | Standard Deviation 26.06 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Cognitive Functioning | 78.47 score on a scale | Standard Deviation 25.02 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Social Functioning | 66.67 score on a scale | Standard Deviation 32.43 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Fatigue | 36.34 score on a scale | Standard Deviation 29.15 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Nausea and Vomiting | 8.50 score on a scale | Standard Deviation 16.36 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Pain | 44.44 score on a scale | Standard Deviation 32.86 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Dyspnea | 13.61 score on a scale | Standard Deviation 20.32 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Insomnia | 34.69 score on a scale | Standard Deviation 35.33 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Appetite Loss | 23.61 score on a scale | Standard Deviation 30.72 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Constipation | 25.85 score on a scale | Standard Deviation 32.82 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Diarrhea | 10.20 score on a scale | Standard Deviation 23.77 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Baseline | Financial concerns | 21.09 score on a scale | Standard Deviation 30.95 |
Secondary
Quality of Life Using EORTC QLQ-C30 - Cycle 3
Patient reported outcomes will be measured using EORTC QLQ-C30 questionnaires. This tool contains 30 items. It measures 5 functional dimensions (physical, role, cognitive, social, emotional), 6 single items (appetite loss, constipation, dyspnea, financial impact, sleep disturbance, diarrhea), 3 symptom items (fatigue, pain, nausea/vomiting) and a global health and quality of life scale. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: At Cycle 3 (Week 6)
Population: Treated patients who completed Quality of Life evaluations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Global Health Status | 59.96 score on a scale | Standard Deviation 18.93 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Physical Functioning | 78.37 score on a scale | Standard Deviation 21.38 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Role Functioning | 63.01 score on a scale | Standard Deviation 32.81 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Emotional Functioning | 81.25 score on a scale | Standard Deviation 23.93 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Cognitive Functioning | 76.83 score on a scale | Standard Deviation 23.53 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Social Functioning | 73.17 score on a scale | Standard Deviation 29.32 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Fatigue | 41.46 score on a scale | Standard Deviation 28.33 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Nausea and Vomiting | 10.57 score on a scale | Standard Deviation 13.31 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Pain | 41.67 score on a scale | Standard Deviation 29.96 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Dyspnea | 16.26 score on a scale | Standard Deviation 22.51 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Insomnia | 29.27 score on a scale | Standard Deviation 30.91 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Appetite Loss | 31.67 score on a scale | Standard Deviation 32.86 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Constipation | 19.51 score on a scale | Standard Deviation 24.69 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Diarrhea | 5.69 score on a scale | Standard Deviation 14.72 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 3 | Financial concerns | 15.45 score on a scale | Standard Deviation 23.68 |
Secondary
Quality of Life Using EORTC QLQ-C30 - Cycle 9
Patient reported outcomes will be measured using EORTC QLQ-C30 questionnaires. This tool contains 30 items. It measures 5 functional dimensions (physical, role, cognitive, social, emotional), 6 single items (appetite loss, constipation, dyspnea, financial impact, sleep disturbance, diarrhea), 3 symptom items (fatigue, pain, nausea/vomiting) and a global health and quality of life scale. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: At Cycle 9 (Week 26)
Population: Treated patients who completed Quality of Life evaluations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Global Health Status | 61.00 score on a scale | Standard Deviation 24.26 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Physical Functioning | 74.93 score on a scale | Standard Deviation 30.57 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Role Functioning | 64.00 score on a scale | Standard Deviation 33.22 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Emotional Functioning | 77.78 score on a scale | Standard Deviation 24.16 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Cognitive Functioning | 75.33 score on a scale | Standard Deviation 33.03 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Social Functioning | 71.33 score on a scale | Standard Deviation 30.63 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Fatigue | 40.00 score on a scale | Standard Deviation 31.75 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Nausea and Vomiting | 8.67 score on a scale | Standard Deviation 21.58 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Pain | 40.00 score on a scale | Standard Deviation 37.27 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Dyspnea | 9.33 score on a scale | Standard Deviation 22.61 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Insomnia | 29.33 score on a scale | Standard Deviation 35.12 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Appetite Loss | 19.44 score on a scale | Standard Deviation 32.48 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Constipation | 20.00 score on a scale | Standard Deviation 30.43 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Diarrhea | 4.00 score on a scale | Standard Deviation 11.06 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-C30 - Cycle 9 | Financial concerns | 17.33 score on a scale | Standard Deviation 30.61 |
Secondary
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months
Patient reported outcomes will be measured using the EORTC QLQ-H&N35, a 35-item questionnaire that assesses symptoms encountered specifically by patients with head and neck cancer. This measure generates 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc). Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: At 12 months
Population: Treated patients who completed Quality of Life evaluations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Pain | 10.00 score on a scale | Standard Deviation 12.3 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Swallowing Problems | 52.50 score on a scale | Standard Deviation 46.98 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Sensory Problems | 30.00 score on a scale | Standard Deviation 29.19 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Speech Problems | 51.11 score on a scale | Standard Deviation 28.3 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Trouble with Social Eating | 54.17 score on a scale | Standard Deviation 41.99 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Trouble with Social Contact | 11.33 score on a scale | Standard Deviation 16.64 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Less Sexuality | 33.33 score on a scale | Standard Deviation 47.14 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Teeth Problems | 33.33 score on a scale | Standard Deviation 38.49 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Mouth Opening Problems | 74.07 score on a scale | Standard Deviation 36.43 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Dry Mouth | 66.67 score on a scale | Standard Deviation 35.14 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Sticky Saliva | 46.67 score on a scale | Standard Deviation 39.13 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Coughing | 26.67 score on a scale | Standard Deviation 34.43 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Feeling Ill | 10.00 score on a scale | Standard Deviation 22.5 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Painkiller Use | 60.00 score on a scale | Standard Deviation 51.64 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Nutritional Supplement Use | 80.00 score on a scale | Standard Deviation 42.16 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Feeding Tube Use | 50.00 score on a scale | Standard Deviation 52.7 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Weight Loss | 20.00 score on a scale | Standard Deviation 42.16 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 12 Months | Weight Gain | 10.00 score on a scale | Standard Deviation 31.62 |
Secondary
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months
Patient reported outcomes will be measured using the EORTC QLQ-H&N35, a 35-item questionnaire that assesses symptoms encountered specifically by patients with head and neck cancer. This measure generates 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc). Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: At 36 months
Population: Treated patients who completed Quality of Life evaluations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Pain | 0.00 score on a scale | Standard Deviation 0 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Swallowing Problems | 66.67 score on a scale | Standard Deviation 11.79 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Sensory Problems | 0.00 score on a scale | Standard Deviation 0 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Speech Problems | 59.26 score on a scale | Standard Deviation 16.97 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Trouble with Social Eating | 72.22 score on a scale | Standard Deviation 34.69 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Trouble with Social Contact | 33.33 score on a scale | Standard Deviation 57.74 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Less Sexuality | 33.33 score on a scale | Standard Deviation 57.74 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Teeth Problems | 22.22 score on a scale | Standard Deviation 19.25 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Mouth Opening Problems | 50.00 score on a scale | Standard Deviation 23.57 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Dry Mouth | 33.33 score on a scale | Standard Deviation 33.33 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Sticky Saliva | 44.44 score on a scale | Standard Deviation 50.92 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Coughing | 11.11 score on a scale | Standard Deviation 19.25 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Feeling Ill | 0.00 score on a scale | Standard Deviation 0 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Painkiller Use | 33.33 score on a scale | Standard Deviation 57.74 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Nutritional Supplement Use | 100.00 score on a scale | Standard Deviation 0 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Feeding Tube Use | 100.00 score on a scale | Standard Deviation 0 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Weight Loss | 0.00 score on a scale | Standard Deviation 0 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - 36 Months | Weight Gain | 0.00 score on a scale | Standard Deviation 0 |
Secondary
Quality of Life Using EORTC QLQ-H&N 35 - Baseline
Patient reported outcomes will be measured using the EORTC QLQ-H&N35, a 35-item questionnaire that assesses symptoms encountered specifically by patients with head and neck cancer. This measure generates 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc). Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: At Baseline
Population: Treated patients who completed Quality of Life evaluations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Pain | 38.89 score on a scale | Standard Deviation 33.21 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Swallowing Problems | 40.08 score on a scale | Standard Deviation 35.13 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Sensory Problems | 32.58 score on a scale | Standard Deviation 32.34 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Speech Problems | 42.68 score on a scale | Standard Deviation 31.69 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Trouble with Social Eating | 39.07 score on a scale | Standard Deviation 32.46 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Trouble with Social Contact | 16.53 score on a scale | Standard Deviation 20.07 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Less Sexuality | 25.19 score on a scale | Standard Deviation 37.54 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Teeth Problems | 21.01 score on a scale | Standard Deviation 36.08 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Mouth Opening Problems | 48.61 score on a scale | Standard Deviation 39.48 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Dry Mouth | 46.53 score on a scale | Standard Deviation 38.12 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Sticky Saliva | 45.14 score on a scale | Standard Deviation 42.66 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Coughing | 35.46 score on a scale | Standard Deviation 34.34 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Feeling Ill | 27.08 score on a scale | Standard Deviation 34.14 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Painkiller Use | 74.47 score on a scale | Standard Deviation 44.08 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Nutritional Supplement Use | 62.50 score on a scale | Standard Deviation 48.92 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Feeding Tube Use | 37.50 score on a scale | Standard Deviation 48.92 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Weight Loss | 31.25 score on a scale | Standard Deviation 46.84 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Baseline | Weight Gain | 20.83 score on a scale | Standard Deviation 41.04 |
Secondary
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3
Patient reported outcomes will be measured using the EORTC QLQ-H&N35, a 35-item questionnaire that assesses symptoms encountered specifically by patients with head and neck cancer. This measure generates 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc). Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: At Cycle 3 (Week 6)
Population: Treated patients who completed Quality of Life evaluations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Pain | 41.87 score on a scale | Standard Deviation 32.09 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Swallowing Problems | 45.83 score on a scale | Standard Deviation 34.47 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Sensory Problems | 43.24 score on a scale | Standard Deviation 29.52 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Speech Problems | 43.54 score on a scale | Standard Deviation 27.89 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Trouble with Social Eating | 47.97 score on a scale | Standard Deviation 32.89 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Trouble with Social Contact | 16.75 score on a scale | Standard Deviation 23.79 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Less Sexuality | 30.56 score on a scale | Standard Deviation 39.14 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Teeth Problems | 16.24 score on a scale | Standard Deviation 29.49 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Mouth Opening Problems | 54.47 score on a scale | Standard Deviation 37.83 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Dry Mouth | 51.22 score on a scale | Standard Deviation 35.82 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Sticky Saliva | 62.50 score on a scale | Standard Deviation 35.56 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Coughing | 37.40 score on a scale | Standard Deviation 30 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Feeling Ill | 21.95 score on a scale | Standard Deviation 29.45 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Painkiller Use | 82.93 score on a scale | Standard Deviation 38.09 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Nutritional Supplement Use | 56.10 score on a scale | Standard Deviation 50.24 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Feeding Tube Use | 58.54 score on a scale | Standard Deviation 49.88 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Weight Loss | 50.00 score on a scale | Standard Deviation 50.64 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 | Weight Gain | 22.50 score on a scale | Standard Deviation 42.29 |
Secondary
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9
Patient reported outcomes will be measured using the EORTC QLQ-H&N35, a 35-item questionnaire that assesses symptoms encountered specifically by patients with head and neck cancer. This measure generates 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc). Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Time frame: At Cycle 9 (Week 26)
Population: Treated patients who completed Quality of Life evaluations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Pain | 29.33 score on a scale | Standard Deviation 25.13 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Swallowing Problems | 31.75 score on a scale | Standard Deviation 33.61 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Sensory Problems | 32.54 score on a scale | Standard Deviation 34.35 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Speech Problems | 40.10 score on a scale | Standard Deviation 29.35 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Trouble with Social Eating | 32.25 score on a scale | Standard Deviation 29.97 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Trouble with Social Contact | 20.27 score on a scale | Standard Deviation 26.28 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Less Sexuality | 32.54 score on a scale | Standard Deviation 40.99 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Teeth Problems | 27.54 score on a scale | Standard Deviation 39.76 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Mouth Opening Problems | 48.00 score on a scale | Standard Deviation 43.12 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Dry Mouth | 52.00 score on a scale | Standard Deviation 33.44 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Sticky Saliva | 52.00 score on a scale | Standard Deviation 36.11 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Coughing | 31.94 score on a scale | Standard Deviation 26.88 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Feeling Ill | 16.00 score on a scale | Standard Deviation 29.06 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Painkiller Use | 68.00 score on a scale | Standard Deviation 47.61 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Nutritional Supplement Use | 62.50 score on a scale | Standard Deviation 49.45 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Feeding Tube Use | 36.00 score on a scale | Standard Deviation 48.99 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Weight Loss | 33.33 score on a scale | Standard Deviation 48.15 |
| Reirradiation + MK-3475 | Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 | Weight Gain | 16.00 score on a scale | Standard Deviation 37.42 |
Secondary
Time to in Field Disease Progression
Number of months from initiation of treatment to progression of disease within the radiation field.Progressive disease, per RECIST 1.1, is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)
Population: Zero patients with results.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reirradiation + MK-3475 | Time to in Field Disease Progression | 13.1 months |