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Cytokine

Bempegaldesleukin for Head and Neck Cancers

Phase 2 & 3
Waitlist Available
Research Sponsored by Nektar Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights

Study Summary

This study is evaluating whether a combination of a drug and a vaccine is more effective than the vaccine alone.

Eligible Conditions
  • Head and Neck Cancers
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate
Overall Survival
Secondary outcome measures
Change in Global Health Status/Quality of Life
Percentage of Patients With Treatment-Emergent Adverse Events and Serious Adverse Events
Progression-Free Survival
+1 more

Side effects data

From 2022 Phase 2 trial • 192 Patients • NCT03785925
44%
Pyrexia
31%
Fatigue
31%
Decreased appetite
30%
Anaemia
30%
Diarrhoea
29%
Nausea
23%
Constipation
23%
Pruritus
21%
Pruritus generalised
21%
Urinary tract infection
19%
Vomiting
19%
Arthralgia
19%
Asthenia
17%
Oedema peripheral
16%
Haematuria
15%
Hypothyroidism
14%
Chills
14%
Eosinophilia
13%
Blood creatinine increased
13%
Influenza like illness
12%
Dizziness
12%
Hypotension
12%
Back pain
11%
Cough
11%
Rash
10%
Dyspnoea
10%
Headache
9%
Hyperthyroidism
9%
Rash maculo-papular
8%
Abdominal pain
8%
Gamma-glutamyltransferase increased
8%
Insomnia
8%
Rash generalised
7%
Musculoskeletal pain
7%
Weight decreased
7%
Dry skin
7%
Hyponatraemia
7%
Pain in extremity
6%
Blood alkaline phosphatase increased
6%
Myalgia
6%
Infusion related reaction
6%
Dry mouth
6%
Amylase increased
6%
Aspartate aminotransferase increased
6%
Hypertension
5%
Acute kidney injury
5%
Face oedema
5%
Alanine aminotransferase increased
5%
Fall
2%
Pulmonary embolism
2%
Pneumonia
2%
Urosepsis
2%
Corona virus infection
1%
Hepatic failure
1%
Ileus
1%
Nephritis
1%
Pyelonephritis acute
1%
Bone pain
1%
Confusional state
1%
Cholecystitis
1%
Intestinal perforation
1%
Pancreatitis
1%
Pancreatic carcinoma metastatic
1%
Hydronephrosis
1%
Female genital tract fistula
1%
Pyelonephritis chronic
1%
Obstruction gastric
1%
Delirium
1%
Intestinal obstruction
1%
Diverticulum intestinal
1%
Inguinal hernia
1%
Pharyngitis
1%
Pyelonephritis
1%
Large intestinal obstruction
1%
Urinary tract infection enterococcal
1%
Atrial fibrillation
1%
Cardiac failure
1%
Renal abscess
1%
Upper respiratory tract infection
1%
Vascular device infection
1%
Bladder neck obstruction
1%
General physical health deterioration
1%
Sepsis
1%
Spinal cord infection
1%
Rectal haemorrhage
1%
Retroperitoneal haemorrhage
1%
Myocarditis
1%
Deep vein thrombosis
1%
Peripheral ischaemia
1%
Dehydration
1%
Cerebrovascular accident
1%
Bacterial sepsis
1%
Escherichia urinary tract infection
1%
Gastroenteritis viral
1%
Herpes zoster
1%
Lung infection
1%
Peritonitis
1%
Chronic kidney disease
1%
Kidney congestion
1%
Renal failure
1%
Urinary retention
1%
Urinary tract discomfort
1%
Urinary tract obstruction
1%
Sudden death
1%
Musculoskeletal chest pain
1%
Pathological fracture
1%
Polymyalgia rheumatica
1%
Acute myocardial infarction
1%
Cardio-respiratory arrest
1%
Peripheral arterial occlusive disease
1%
Peripheral artery thrombosis
1%
Thrombophlebitis superficial
1%
Hyperglycaemia
1%
Hypervolaemia
1%
Type 2 diabetes mellitus
1%
Febrile neutropenia
1%
Haemorrhagic anaemia
1%
Cerebral infarction
1%
Cerebral microembolism
1%
Lung disorder
1%
Cervical vertebral fracture
1%
Lumbar vertebral fracture
1%
Procedural pain
1%
Breast cancer
1%
Malignant melanoma in situ
1%
Perineal pain
1%
Scrotal pain
1%
Cutaneous vasculitis
1%
Stevens-Johnson syndrome
1%
Hypophysitis
1%
Drug hypersensitivity
1%
Device occlusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BEMPEG + PembrolizumabExperimental Treatment2 Interventions
Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).
Group II: Pembrolizumab MonotherapyActive Control1 Intervention
Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bempegaldesleukin
2020
Completed Phase 3
~380
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,891 Previous Clinical Trials
5,060,420 Total Patients Enrolled
Nektar TherapeuticsLead Sponsor
58 Previous Clinical Trials
10,341 Total Patients Enrolled
SFJ Pharmaceuticals, Inc.Industry Sponsor
5 Previous Clinical Trials
1,165 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)
2022. "BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04969861.
~0 spots leftby Apr 2025
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