Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma

Phase II Study of Bempegaldesleukin (NKTR-214) Together With Palliative Radiation and Anti-PD-1 Checkpoint Blockade in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04936841

Enrollment

Registered

2021-06-23

Start date

2021-08-05

Completion date

2022-10-04

Last updated

2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Brief summary

This trial will evaluate safety and efficacy of the combination of anti-PD1, NKTR-214, and palliative radiation therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Twenty-four participants will be enrolled to evaluate the efficacy of this combination.

Detailed description

Following an informed consent process, participants will receive anti-PD-1 therapy with 200 mg of pembrolizumab and NKTR-214 at 0.006 mg/kg. Palliative radiation therapy will then be delivered to tumor sites causing or felt by the treating physician to have a high potential for causing symptoms with either 8 Gy X 3 or 4 Gy X 5 completed 3 to 7 days prior to cycle 2 of anti-PD1 and NKTR-214. Combined anti-PD-1 and NKTR-214 will then be delivered each subsequent cycle. Efficacy will be measured by overall response rate (ORR), progression free survival (PFS), overall survival (OS), clinical benefit (CB), and duration of response with ORR the primary outcome being compared to historical control data. Toxicity will be evaluated prior to administration of each 21-day cycle, while receiving NKTR-214 followed by every four months after the participant is off trial. Health related quality of life questionnaires will be completed with cycle 1 and 2 and then every 4 cycles thereafter.

Interventions

DRUGNKTR-214

Bempegaldesleukin (NKTR-214) is an immunotherapeutic protein prodrug specifically designed to activate the patient's immune system for the treatment of cancer by providing a controlled, sustained signal to the interleukin-2 (IL-2) receptor pathway (pharmacological classification: immunostimulatory interleukin cytokine)

DRUGanti-PD-1 therapy

immunotherapy drug, monoclonal antibody

RADIATIONPalliative Radiation

radiation to relieve symptoms

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately * Qualify for anti-PD-1 therapy based on current guidelines at the time of registration. This includes the standard requirement for the participant's tumor to have been previously determined to express PD-L1 with a combined positive score ≥ 1, as determined by an FDA-approved test. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 30 days prior to enrollment * Histologically proven diagnosis of head and neck squamous cell carcinoma that is metastatic or recurrent disease that is surgically incurable * Prior cancer treatment other than anti-PD-1 therapy must be completed at least 30 days prior to registration and the participant must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or baseline. Participants may not undergo concurrent anti-cancer treatment during treatment with protocol therapies. This includes no treatment with growth factors, tyrosine kinase inhibitors, tumor-specific antibodies, or cytotoxic chemotherapies such as cisplatin. Participants who have previously or are currently taking an anti-PD-1 therapy are eligible for this study if they meet eligibility criteria 2. Participants who have previously taken any other immune checkpoint inhibitor are eligible as long as they have completed that treatment at least 30 days prior to registration and meet all other eligibility criteria. * Participants with central nervous system (CNS) metastases are eligible if the CNS lesions are stable for at least 2 months and if tapered off treatment doses of systemic corticosteroids for at least 2 weeks prior to enrollment on the trial. Management with maintenance physiologic doses of corticosteroids (equivalent doses of prednisone ≤ 10 mg daily) is acceptable. * Participants must have an index tumor that: 1) is deemed by the treating radiation oncologist to potentially benefit from palliative radiation 2) is amenable to biopsy, 3) is ≥ 1 cm in longest dimension. * Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 30 days prior to enrollment * White blood cell (WBC) ≥ 3,000/mm3 * Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 * Hemoglobin (Hgb) ≥ 9 g/dL * Platelets ≥ 100,000/mm3 * Serum creatinine ≤ 2.0 mg/dL * Total Bilirubin ≤ 2.0 × upper limit of normal (ULN) (\< 3.0 for subjects with Gilbert's Syndrome) * Aspartate aminotransferase (AST) ≤ 3 × ULN * Alanine aminotransferase (ALT) ≤ 3 × ULN * Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment and must agree to use effective contraception during active treatment and for 5 months after last dose of pembrolizumab and/or NKTR-214. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for ≥ 12 consecutive months. * As determined by the enrolling physician or protocol designee, ability of the participant to understand and comply with study procedures for the entire length of the study

Exclusion criteria

* Subjects with significant intercurrent illnesses per physician discretion * Subjects with active or acute infections or active peptic ulcers, unless these conditions are adequately corrected or controlled, in the opinion of the treating physician * Subjects with a diagnosed auto-immune disease (exceptions: subjects with controlled diabetes mellitus type I, thyroid disease, rheumatoid arthritis, vitiligo and alopecia areata not requiring treatment with immunosuppressants are eligible) * Subjects with a history of diabetes mellitus requiring systemic therapy within the past 3 months (i.e. either oral hypoglycemic agents or insulin) must have a documented Hemoglobin A1c \< 8.0 % within 90 days of registration. * Subjects with known genetic conditions causing pre-disposition to radiotherapy (RT) toxicity (i.e.: Li-Fraumeni, ATM deficiency, active scleroderma, etc.) * Participants with a prior diagnosis of cerebrovascular accident (CVA) or transient ischemic attack (TIA) * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study) * Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least three years prior to enrollment * Prolonged Fridericia's corrected QT interval (QTcF) \> 450 ms for men and \> 470 ms for women at time of enrollment * Subjects with symptoms of ischemic cardiac disease, congestive heart failure, or myocardial infarction within 6 months of registration and/or uncontrolled cardiac rhythm disturbance * Subjects with a pulmonary embolism, deep vein thrombosis, or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (e.g., internal jugular vein thrombosis) within 3 months prior to enrollment * Patients with a history of a venous or arterial thromboembolic event must be asymptomatic prior to enrollment and must be receiving a stable regimen of therapeutic anticoagulation (low molecular weight heparin (LMWH) or direct oral anticoagulation (DOAC)). Use of coumadin is permitted; however, therapeutic dosing should target a specific international normalized ratio (INR) stable for at least 4 weeks prior to enrollment. NKTR-214 has the potential to down-regulate metabolizing enzymes for coumadin for approximately 1 week after administration of each dose of NKTR-214. Due to the possibility of drug-drug interactions between coumadin and NKTR-214, frequent monitoring of INR and ongoing consideration of dose adjustments are warranted throughout the patient's participation on study. * Subjects with significant psychiatric disabilities or seizure disorders if considered unsafe in the opinion of the treating physician * Subjects with symptomatic pleural effusions or ascites * Subjects with organ allografts * Subjects who require, or are likely to require, systemic treatment doses of corticosteroids, or other immunosuppressive drugs, or have used them within 2 weeks of registration (clarification: subjects receiving physiologic maintenance or replacement doses of systemic steroids or inhaled steroids are eligible) * Subjects with known human immunodeficiency virus (HIV) infection, active or chronic hepatitis B or hepatitis C infection, or with clinical evidence of hepatitis 15. Subjects with known hypersensitivity to IL2 or those who experienced significant immune-related AEs requiring treatment with steroids or other immunosuppressant therapy during prior treatment with ipilimumab, or anti- PD-1/PD-L1 checkpoint blockade therapy 16. Subjects who cannot provide independent, legal, informed consent

Design outcomes

Primary

Measure	Time frame	Description
Objective Response Rate (ORR)	up to 7 months (at Standard-of-care imaging 3 to 6 months after Cycle 1)	ORR is the percentage of participants whose cancer shrinks or disappears after treatment. ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST1.1, by investigator assessment.

Secondary

Measure	Time frame	Description
Overall Survival (OS)	up to 14 months (study terminated early)	OS is defined as time from day 1 of treatment until death as a result of any cause.
Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)	European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a measure of health-related quality of life for cancer patients participating in clinical trials. It scores the following domains from 0-100 where higher global or functional scores indicate increased quality of life and higher symptom scores indicate increased symptoms: Global health status (QL2), Physical functioning (PF2), Role functioning (RF2), Emotional functioning (EF), Cognitive functioning (CF), and Social functioning (SF).
Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)	European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a measure of health-related quality of life for cancer patients participating in clinical trials. It scores the following domains from 0-100 where higher symptom scores indicate increased symptoms: Fatigue (FA), Nausea and vomiting (NV), Pain (PA), Dyspnea (DY), Insomnia (SL), Appetite loss (AP), Constipation (CO), Diarrhea (DI), Financial difficulties (FI)
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)	European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire - Head and Neck (EORTC QLQ-H&N35) is comprised of the following subscales, scored from 0-100 where higher scores indicate increased symptoms: Pain (HNPA), Swallowing (HNSW), Senses problem (HNSE), Speech problems (HNSP), Trouble with social eating (HNSO), Trouble with social contact (HNSC), Less sexuality (HNSX), Teeth (HNTE), Opening mouth (HNOM), Dry mouth (HNDR), Sticky saliva (HNSS), Coughing (HNCO), Felt ill (HNFI), pain killers (HNPK), Nutritional supplements (HNNU), Feeding tube (HNFE), Weight loss (HNFL), Weight gain (HNWG)
Health Related Quality of Life as Measured by EQ-5D Participant Counts	Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)	The EQ-5D is a 5 question measure of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus an overall measure of health reported on a visual analog scale. Participant counts are reported for each of 5 dimensions: mobility, self-care, usual activities, pain / discomfort, anxiety / depression.
Number of Participants With Adverse Events Greater Than or Equal to Grade 3	up to 14 months (study terminated early)	Toxicities ≥ Grade 3 is defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicities not unrelated to treatment, will be considered treatment-related. Adverse events are evaluated by the physician graded from 1-5 where 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death.
Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	up to 14 months (study terminated early)	Toxicities ≥ Grade 3 is defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicities not unrelated to treatment, will be considered treatment-related. Adverse events are evaluated by the physician and graded from 1-5 where 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death.
Progression Free Survival (PFS)	up to 14 months (study terminated early)	PFS is the average length of time after the start of treatment in which a person is alive, and their cancer does not grow or spread. PFS is defined as the time from day 1 of treatment until the criteria for disease progression is met as defined by RECIST1.1 or death as a result of any cause.
Number of Participants With Clinical Benefit (CB)	up to 14 months (study terminated early)	CB will include confirmed complete response (CR) + confirmed partial response (PR) + stable disease at ≥ 6 months (SD) and will be determined as per RECIST1.1.
Duration of Response	up to 14 months (study terminated early)	Duration of response is the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented.

Other

Measure	Time frame	Description
Diversity and Clonality of the T Cell Receptor Repertoire by Deep Sequencing of PBMC	up to 5 years	Evaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.
Levels of Tumor Infiltrating Lymphocytes by Histology	up to 3 months	Evaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.
Levels of IFN-γ Expressing and CD122+ T Cells in Peripheral Blood Mononuclear Cells (PBMC)	up to 5 years	Evaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.
Expression of PD-L1 by Histology	up to 3 months	PD-L1 expression has been shown to predict response to immunotherapy regimens. If PD-L1 expression correlates with outcome, it could be used in the future to select patients who have greatest benefit from this regimen.

Countries

United States

Participant flow

Recruitment details

Participants were consented from August 2021 to February 2022.

Participants by arm

Arm	Count
NKTR-214, Anti-PD Therapy Plus Palliative Radiation Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2. In subsequent cycles participants will receive NKTR-214 and anti-PD-1.	5
Total	5

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	1

Baseline characteristics

Characteristic	NKTR-214, Anti-PD Therapy Plus Palliative Radiation
Age, Customized 50-59 years old	3 Participants
Age, Customized 60-69 years old	1 Participants
Age, Customized 70-79 years old	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 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	5 Participants
Region of Enrollment United States	5 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 5
other Total, other adverse events	5 / 5
serious Total, serious adverse events	1 / 5

Outcome results

Primary

Objective Response Rate (ORR)

ORR is the percentage of participants whose cancer shrinks or disappears after treatment. ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST1.1, by investigator assessment.

Time frame: up to 7 months (at Standard-of-care imaging 3 to 6 months after Cycle 1)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Objective Response Rate (ORR)	2 Participants

Secondary

Duration of Response

Duration of response is the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented.

Time frame: up to 14 months (study terminated early)

Arm	Measure	Value (MEAN)	Dispersion
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Duration of Response	6.59 months	Standard Deviation 3.7

Secondary

Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a measure of health-related quality of life for cancer patients participating in clinical trials. It scores the following domains from 0-100 where higher global or functional scores indicate increased quality of life and higher symptom scores indicate increased symptoms: Global health status (QL2), Physical functioning (PF2), Role functioning (RF2), Emotional functioning (EF), Cognitive functioning (CF), and Social functioning (SF).

Time frame: Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)

Arm	Measure	Group	Value (MEDIAN)	Dispersion
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	QL2	66.7 score on a scale	Standard Deviation 34.56
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	PF2	100 score on a scale	Standard Deviation 29.81
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	RF2	100.0 score on a scale	Standard Deviation 44.72
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	EF	66.7 score on a scale	Standard Deviation 25
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	CF	83.3 score on a scale	Standard Deviation 13.94
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	SF	83.3 score on a scale	Standard Deviation 13.9
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	CF	83.3 score on a scale	Standard Deviation 21.73
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	SF	83.3 score on a scale	Standard Deviation 20.41
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	QL2	50.0 score on a scale	Standard Deviation 22.82
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	RF2	100.0 score on a scale	Standard Deviation 22.36
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	EF	66.7 score on a scale	Standard Deviation 20.07
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	PF2	93.3 score on a scale	Standard Deviation 28.05
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	EF	87.5 score on a scale	Standard Deviation 17.18
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	CF	100.0 score on a scale	Standard Deviation 0
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	QL2	70.8 score on a scale	Standard Deviation 20.83
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	RF2	66.7 score on a scale	Standard Deviation 16.67
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	PF2	90.0 score on a scale	Standard Deviation 11.55
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	SF	100.0 score on a scale	Standard Deviation 25
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	EF	83.3 score on a scale	Standard Deviation 21.92
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	PF2	93.3 score on a scale	Standard Deviation 7.7
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	RF2	91.7 score on a scale	Standard Deviation 15.96
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	SF	91.7 score on a scale	Standard Deviation 31.55
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	CF	91.7 score on a scale	Standard Deviation 15.96
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	QL2	75.0 score on a scale	Standard Deviation 40.82
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	CF	83.3 score on a scale	Standard Deviation 25
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	RF2	83.3 score on a scale	Standard Deviation 19.25
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	PF2	93.3 score on a scale	Standard Deviation 7.7
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	SF	91.7 score on a scale	Standard Deviation 23.57
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	EF	83.3 score on a scale	Standard Deviation 21.92
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores	QL2	62.5 score on a scale	Standard Deviation 29.27

Secondary

Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a measure of health-related quality of life for cancer patients participating in clinical trials. It scores the following domains from 0-100 where higher symptom scores indicate increased symptoms: Fatigue (FA), Nausea and vomiting (NV), Pain (PA), Dyspnea (DY), Insomnia (SL), Appetite loss (AP), Constipation (CO), Diarrhea (DI), Financial difficulties (FI)

Time frame: Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)

Arm	Measure	Group	Value (MEDIAN)	Dispersion
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	FI	0.0 score on a scale	Standard Deviation 43.46
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	SL	33.3 score on a scale	Standard Deviation 27.89
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	NV	0.0 score on a scale	Standard Deviation 21.73
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	AP	33.3 score on a scale	Standard Deviation 40.82
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	DI	0.0 score on a scale	Standard Deviation 0
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	PA	33.3 score on a scale	Standard Deviation 40.14
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	CO	0.0 score on a scale	Standard Deviation 18.26
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	DY	0.0 score on a scale	Standard Deviation 14.91
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	FA	13.3 score on a scale	Standard Deviation 20.76
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	CO	0.0 score on a scale	Standard Deviation 43.46
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	AP	33.3 score on a scale	Standard Deviation 33.33
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	DY	0.0 score on a scale	Standard Deviation 18.26
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	SL	33.3 score on a scale	Standard Deviation 27.89
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	PA	33.3 score on a scale	Standard Deviation 21.73
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	FI	0.0 score on a scale	Standard Deviation 29.81
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	NV	16.7 score on a scale	Standard Deviation 19
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	FA	20.0 score on a scale	Standard Deviation 10.11
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	DI	0.0 score on a scale	Standard Deviation 0
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	AP	16.7 score on a scale	Standard Deviation 31.91
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	FA	16.7 score on a scale	Standard Deviation 9.43
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	NV	16.7 score on a scale	Standard Deviation 20.97
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	PA	25.0 score on a scale	Standard Deviation 21.52
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	DY	0.0 score on a scale	Standard Deviation 16.67
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	SL	16.7 score on a scale	Standard Deviation 31.91
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	CO	0.0 score on a scale	Standard Deviation 33.33
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	DI	0.0 score on a scale	Standard Deviation 16.67
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	FI	0.0 score on a scale	Standard Deviation 16.67
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	DY	0.0 score on a scale	Standard Deviation 16.67
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	AP	16.7 score on a scale	Standard Deviation 31.91
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	PA	25.0 score on a scale	Standard Deviation 28.87
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	CO	0.0 score on a scale	Standard Deviation 16.67
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	NV	16.7 score on a scale	Standard Deviation 25
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	FI	0.0 score on a scale	Standard Deviation 16.67
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	DI	0.0 score on a scale	Standard Deviation 16.67
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	FA	13.3 score on a scale	Standard Deviation 17.53
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	SL	16.7 score on a scale	Standard Deviation 47.14
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	FA	23.3 score on a scale	Standard Deviation 18.36
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	DY	0.0 score on a scale	Standard Deviation 16.67
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	AP	0.0 score on a scale	Standard Deviation 50
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	PA	16.7 score on a scale	Standard Deviation 39.38
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	SL	0.0 score on a scale	Standard Deviation 33.33
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	FI	0.0 score on a scale	Standard Deviation 16.67
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	DI	16.7 score on a scale	Standard Deviation 19.25
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	CO	0.0 score on a scale	Standard Deviation 16.67
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores	NV	0.0 score on a scale	Standard Deviation 16.67

Secondary

Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire - Head and Neck (EORTC QLQ-H&N35) is comprised of the following subscales, scored from 0-100 where higher scores indicate increased symptoms: Pain (HNPA), Swallowing (HNSW), Senses problem (HNSE), Speech problems (HNSP), Trouble with social eating (HNSO), Trouble with social contact (HNSC), Less sexuality (HNSX), Teeth (HNTE), Opening mouth (HNOM), Dry mouth (HNDR), Sticky saliva (HNSS), Coughing (HNCO), Felt ill (HNFI), pain killers (HNPK), Nutritional supplements (HNNU), Feeding tube (HNFE), Weight loss (HNFL), Weight gain (HNWG)

Time frame: Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)

Arm	Measure	Group	Value (MEDIAN)	Dispersion
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNTE	0 score on a scale	Standard Deviation 14.91
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSX	0 score on a scale	Standard Deviation 54.77
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSO	25 score on a scale	Standard Deviation 24.58
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNFE	20 score on a scale	Standard Deviation 44.72
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSC	0 score on a scale	Standard Deviation 12.99
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSW	8.33 score on a scale	Standard Deviation 12.63
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNWG	40 score on a scale	Standard Deviation 54.77
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNNU	60 score on a scale	Standard Deviation 54.77
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNPK	60 score on a scale	Standard Deviation 54.77
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNFI	0 score on a scale	Standard Deviation 14.91
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSE	16.67 score on a scale	Standard Deviation 21.73
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNPA	25 score on a scale	Standard Deviation 19
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNCO	33.33 score on a scale	Standard Deviation 23.57
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSS	66.67 score on a scale	Standard Deviation 18.26
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNDR	66.67 score on a scale	Standard Deviation 43.46
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSP	11.11 score on a scale	Standard Deviation 14.49
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNWL	40 score on a scale	Standard Deviation 54.77
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNOM	0 score on a scale	Standard Deviation 18.26
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSE	0 score on a scale	Standard Deviation 36.13
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNPA	33.33 score on a scale	Standard Deviation 18.26
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSW	8.33 score on a scale	Standard Deviation 18.07
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSP	0 score on a scale	Standard Deviation 21.29
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSO	16.67 score on a scale	Standard Deviation 36.13
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSC	0 score on a scale	Standard Deviation 21.29
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSX	16.67 score on a scale	Standard Deviation 41.83
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNTE	0 score on a scale	Standard Deviation 29.81
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNOM	0 score on a scale	Standard Deviation 18.26
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNDR	66.67 score on a scale	Standard Deviation 27.89
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSS	33.33 score on a scale	Standard Deviation 33.33
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNCO	66.67 score on a scale	Standard Deviation 43.46
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNFI	3.33 score on a scale	Standard Deviation 23.57
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNPK	80 score on a scale	Standard Deviation 44.72
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNNU	40 score on a scale	Standard Deviation 54.77
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNFE	20 score on a scale	Standard Deviation 44.72
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNWL	20 score on a scale	Standard Deviation 44.72
Grade 4	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNWG	20 score on a scale	Standard Deviation 44.72
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNWG	25 score on a scale	Standard Deviation 50
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSE	0 score on a scale	Standard Deviation 25
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSC	6.67 score on a scale	Standard Deviation 22.03
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNCO	3.33 score on a scale	Standard Deviation 41.93
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNFE	0 score on a scale	Standard Deviation 0
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNNU	75 score on a scale	Standard Deviation 50
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSW	20.83 score on a scale	Standard Deviation 27.64
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNPK	75 score on a scale	Standard Deviation 50
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNFI	16.67 score on a scale	Standard Deviation 31.91
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSP	16.67 score on a scale	Standard Deviation 19.25
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNPA	20.83 score on a scale	Standard Deviation 22.95
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNDR	50 score on a scale	Standard Deviation 19.25
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNTE	0 score on a scale	Standard Deviation 16.67
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSO	16.67 score on a scale	Standard Deviation 35.6
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNOM	16.67 score on a scale	Standard Deviation 19.25
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNWL	0 score on a scale	Standard Deviation 0
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSS	33.33 score on a scale	Standard Deviation 16.67
Grade 5	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSX	0 score on a scale	Standard Deviation 50
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSO	12.5 score on a scale	Standard Deviation 39.31
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNTE	0 score on a scale	Standard Deviation 16.67
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNPA	0 score on a scale	Standard Deviation 29.17
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNOM	16.67 score on a scale	Standard Deviation 19.25
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNWG	25 score on a scale	Standard Deviation 25
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNDR	50 score on a scale	Standard Deviation 43.03
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSE	8.33 score on a scale	Standard Deviation 31.55
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSS	16.67 score on a scale	Standard Deviation 31.91
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNWL	0 score on a scale	Standard Deviation 0
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNCO	16.67 score on a scale	Standard Deviation 31.91
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNFI	16.67 score on a scale	Standard Deviation 47.14
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSW	8.33 score on a scale	Standard Deviation 27.53
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNPK	50 score on a scale	Standard Deviation 57.74
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNNU	50 score on a scale	Standard Deviation 57.74
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSC	6.67 score on a scale	Standard Deviation 28.48
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNFE	0 score on a scale	Standard Deviation 0
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSX	16.67 score on a scale	Standard Deviation 47.14
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSP	5.56 score on a scale	Standard Deviation 15.71
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNCO	50 score on a scale	Standard Deviation 31.91
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSX	16.67 score on a scale	Standard Deviation 47.17
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNNU	50 score on a scale	Standard Deviation 0
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNPA	29.17 score on a scale	Standard Deviation 42.22
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSS	33.34 score on a scale	Standard Deviation 50
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNFE	0 score on a scale	Standard Deviation 0
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSO	45.83 score on a scale	Standard Deviation 55.43
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNDR	33.33 score on a scale	Standard Deviation 50
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSE	16.67 score on a scale	Standard Deviation 25
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNOM	0 score on a scale	Standard Deviation 50
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNTE	16.67 score on a scale	Standard Deviation 19.25
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSC	10 score on a scale	Standard Deviation 28.24
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNFI	0 score on a scale	Standard Deviation 33.33
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNWL	75 score on a scale	Standard Deviation 50
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSP	22.22 score on a scale	Standard Deviation 25.66
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNPK	50 score on a scale	Standard Deviation 57.74
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNSW	20.83 score on a scale	Standard Deviation 39.89
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores	HNWG	0 score on a scale	Standard Deviation 0

Secondary

Health Related Quality of Life as Measured by EQ-5D Participant Counts

The EQ-5D is a 5 question measure of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus an overall measure of health reported on a visual analog scale. Participant counts are reported for each of 5 dimensions: mobility, self-care, usual activities, pain / discomfort, anxiety / depression.

Time frame: Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Severe problems / Severe pain / Severe anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	No problems / No Pain / No Anxiety	4 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Severe problems / Severe pain / Severe anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	No problems / No Pain / No Anxiety	4 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Severe problems / Severe pain / Severe anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Slight problems / Slight pain / Slight anxiety	3 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Slight problems / Slight pain / Slight anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	No problems / No Pain / No Anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Slight problems / Slight pain / Slight anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	No problems / No Pain / No Anxiety	4 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Severe problems / Severe pain / Severe anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Moderate problems / Moderate pain / Moderate anxiety	2 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Slight problems / Slight pain / Slight anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	No problems / No Pain / No Anxiety	2 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Severe problems / Severe pain / Severe anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Slight problems / Slight pain / Slight anxiety	2 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Unable / Extreme pain / Extreme anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	No problems / No Pain / No Anxiety	3 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Severe problems / Severe pain / Severe anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Slight problems / Slight pain / Slight anxiety	2 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Severe problems / Severe pain / Severe anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Severe problems / Severe pain / Severe anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Unable / Extreme pain / Extreme anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	No problems / No Pain / No Anxiety	3 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	No problems / No Pain / No Anxiety	4 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Slight problems / Slight pain / Slight anxiety	1 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Slight problems / Slight pain / Slight anxiety	2 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Unable / Extreme pain / Extreme anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Severe problems / Severe pain / Severe anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	No problems / No Pain / No Anxiety	4 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Unable / Extreme pain / Extreme anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	No problems / No Pain / No Anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Slight problems / Slight pain / Slight anxiety	1 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Slight problems / Slight pain / Slight anxiety	2 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Moderate problems / Moderate pain / Moderate anxiety	3 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Unable / Extreme pain / Extreme anxiety	0 Participants
Grade 4	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Severe problems / Severe pain / Severe anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Severe problems / Severe pain / Severe anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Moderate problems / Moderate pain / Moderate anxiety	1 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Unable / Extreme pain / Extreme anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Slight problems / Slight pain / Slight anxiety	2 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Unable / Extreme pain / Extreme anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	No problems / No Pain / No Anxiety	2 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Severe problems / Severe pain / Severe anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Severe problems / Severe pain / Severe anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	No problems / No Pain / No Anxiety	2 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Unable / Extreme pain / Extreme anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Slight problems / Slight pain / Slight anxiety	1 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	No problems / No Pain / No Anxiety	4 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Slight problems / Slight pain / Slight anxiety	1 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	No problems / No Pain / No Anxiety	3 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Slight problems / Slight pain / Slight anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Unable / Extreme pain / Extreme anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	No problems / No Pain / No Anxiety	4 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Slight problems / Slight pain / Slight anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Severe problems / Severe pain / Severe anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Severe problems / Severe pain / Severe anxiety	0 Participants
Grade 5	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Severe problems / Severe pain / Severe anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	No problems / No Pain / No Anxiety	4 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Slight problems / Slight pain / Slight anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Severe problems / Severe pain / Severe anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	No problems / No Pain / No Anxiety	4 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Slight problems / Slight pain / Slight anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Severe problems / Severe pain / Severe anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	No problems / No Pain / No Anxiety	2 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Slight problems / Slight pain / Slight anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Moderate problems / Moderate pain / Moderate anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Severe problems / Severe pain / Severe anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Unable / Extreme pain / Extreme anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	No problems / No Pain / No Anxiety	2 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Slight problems / Slight pain / Slight anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Moderate problems / Moderate pain / Moderate anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Severe problems / Severe pain / Severe anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	No problems / No Pain / No Anxiety	3 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Slight problems / Slight pain / Slight anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Severe problems / Severe pain / Severe anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Severe problems / Severe pain / Severe anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Moderate problems / Moderate pain / Moderate anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Slight problems / Slight pain / Slight anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	No problems / No Pain / No Anxiety	2 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Severe problems / Severe pain / Severe anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	No problems / No Pain / No Anxiety	4 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	No problems / No Pain / No Anxiety	3 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	Slight problems / Slight pain / Slight anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	USUAL ACTIVITIES	No problems / No Pain / No Anxiety	4 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Slight problems / Slight pain / Slight anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Severe problems / Severe pain / Severe anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	SELF-CARE	Slight problems / Slight pain / Slight anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Moderate problems / Moderate pain / Moderate anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	Slight problems / Slight pain / Slight anxiety	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	ANXIETY / DEPRESSION	No problems / No Pain / No Anxiety	3 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	PAIN / DISCOMFORT	Unable / Extreme pain / Extreme anxiety	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)	Health Related Quality of Life as Measured by EQ-5D Participant Counts	MOBILITY	Severe problems / Severe pain / Severe anxiety	0 Participants

Secondary

Number of Participants With Adverse Events Greater Than or Equal to Grade 3

Toxicities ≥ Grade 3 is defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicities not unrelated to treatment, will be considered treatment-related. Adverse events are evaluated by the physician graded from 1-5 where 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death.

Time frame: up to 14 months (study terminated early)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Number of Participants With Adverse Events Greater Than or Equal to Grade 3	2 Participants

Secondary

Number of Participants With Clinical Benefit (CB)

CB will include confirmed complete response (CR) + confirmed partial response (PR) + stable disease at ≥ 6 months (SD) and will be determined as per RECIST1.1.

Time frame: up to 14 months (study terminated early)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Number of Participants With Clinical Benefit (CB)	2 Participants

Secondary

Overall Survival (OS)

OS is defined as time from day 1 of treatment until death as a result of any cause.

Time frame: up to 14 months (study terminated early)

Arm	Measure	Value (MEAN)	Dispersion
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Overall Survival (OS)	13.6 months	Standard Deviation 9.3

Secondary

Progression Free Survival (PFS)

PFS is the average length of time after the start of treatment in which a person is alive, and their cancer does not grow or spread. PFS is defined as the time from day 1 of treatment until the criteria for disease progression is met as defined by RECIST1.1 or death as a result of any cause.

Time frame: up to 14 months (study terminated early)

Arm	Measure	Value (MEDIAN)	Dispersion
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Progression Free Survival (PFS)	4.2 months	Standard Deviation 4.1

Secondary

Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them

Toxicities ≥ Grade 3 is defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicities not unrelated to treatment, will be considered treatment-related. Adverse events are evaluated by the physician and graded from 1-5 where 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death.

Time frame: up to 14 months (study terminated early)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Weight Loss	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Dry Mouth	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Sepsis	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Skin Ulceration	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Thrush	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Lymphocyte Count Decreased	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hyperthyroidism	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hypoalbuminemia	1 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hyponatremia	0 Participants
NKTR-214, Anti-PD Therapy Plus Palliative Radiation	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hypercalcemia	0 Participants
Grade 4	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hyponatremia	1 Participants
Grade 4	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Weight Loss	0 Participants
Grade 4	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Lymphocyte Count Decreased	1 Participants
Grade 4	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Thrush	0 Participants
Grade 4	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Dry Mouth	0 Participants
Grade 4	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hypercalcemia	1 Participants
Grade 4	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hypoalbuminemia	0 Participants
Grade 4	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Sepsis	0 Participants
Grade 4	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hyperthyroidism	0 Participants
Grade 4	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Skin Ulceration	0 Participants
Grade 5	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hypoalbuminemia	0 Participants
Grade 5	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Skin Ulceration	0 Participants
Grade 5	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Thrush	0 Participants
Grade 5	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Lymphocyte Count Decreased	0 Participants
Grade 5	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hyponatremia	0 Participants
Grade 5	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hyperthyroidism	0 Participants
Grade 5	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Weight Loss	0 Participants
Grade 5	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Hypercalcemia	0 Participants
Grade 5	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Dry Mouth	0 Participants
Grade 5	Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them	Sepsis	1 Participants

Other Pre-specified

Diversity and Clonality of the T Cell Receptor Repertoire by Deep Sequencing of PBMC

Evaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.

Time frame: up to 5 years

Other Pre-specified

Expression of PD-L1 by Histology

PD-L1 expression has been shown to predict response to immunotherapy regimens. If PD-L1 expression correlates with outcome, it could be used in the future to select patients who have greatest benefit from this regimen.

Time frame: up to 3 months

Other Pre-specified

Levels of IFN-γ Expressing and CD122+ T Cells in Peripheral Blood Mononuclear Cells (PBMC)

Evaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.

Time frame: up to 5 years

Other Pre-specified

Levels of Tumor Infiltrating Lymphocytes by Histology

Evaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.

Time frame: up to 3 months

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026

Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Objective Response Rate (ORR)

Duration of Response

Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores

Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores

Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores

Health Related Quality of Life as Measured by EQ-5D Participant Counts

Number of Participants With Adverse Events Greater Than or Equal to Grade 3

Number of Participants With Clinical Benefit (CB)

Overall Survival (OS)

Progression Free Survival (PFS)

Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them

Diversity and Clonality of the T Cell Receptor Repertoire by Deep Sequencing of PBMC

Expression of PD-L1 by Histology

Levels of IFN-γ Expressing and CD122+ T Cells in Peripheral Blood Mononuclear Cells (PBMC)

Levels of Tumor Infiltrating Lymphocytes by Histology