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Checkpoint Inhibitor

Bempegaldesleukin for Melanoma (PIVOT-12 Trial)

Phase 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 months
Awards & highlights

PIVOT-12 Trial Summary

This trial compares two immunotherapy drugs to see which is more effective in treating melanoma.

Eligible Conditions
  • Melanoma
  • Skin Cancer

PIVOT-12 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
Secondary outcome measures
Changes at 6 Months of Treatment From Baseline in Scores for the Global Health/Quality of Life (GH/QoL) and Physical Functioning Subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire
Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry.
Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry.
+5 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%
Pancreatitis
1%
Hydronephrosis
1%
Female genital tract fistula
1%
Pyelonephritis chronic
1%
Obstruction gastric
1%
Delirium
1%
Large intestinal obstruction
1%
Intestinal obstruction
1%
Diverticulum intestinal
1%
Inguinal hernia
1%
Intestinal perforation
1%
Pharyngitis
1%
Pyelonephritis
1%
Urinary tract infection enterococcal
1%
Pancreatic carcinoma metastatic
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

PIVOT-12 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Combination of bempegaldesleukin (NKTR-214) + nivolumabExperimental Treatment2 Interventions
Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.
Group II: NivolumabActive Control1 Intervention
Arm B: Participants will receive nivolumab IV alone every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Bempegaldesleukin
2020
Completed Phase 3
~380

Find a Location

Who is running the clinical trial?

Nektar TherapeuticsLead Sponsor
58 Previous Clinical Trials
9,577 Total Patients Enrolled
4 Trials studying Melanoma
1,404 Patients Enrolled for Melanoma
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,267 Total Patients Enrolled
177 Trials studying Melanoma
56,778 Patients Enrolled for Melanoma
Study DirectorStudy DirectorNektar Therapeutics
1,210 Previous Clinical Trials
488,724 Total Patients Enrolled
5 Trials studying Melanoma
929 Patients Enrolled for Melanoma

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
Future OncologyJournal
PIVOT-12: A Phase III Study of Adjuvant Bempegaldesleukin Plus Nivolumab in Resected Stage III/IV Melanoma at High Risk for Recurrence
Eggermont, Alexander MM, Paolo A Ascierto, Nikhil I Khushalani, Dirk Schadendorf, Genevieve Boland, Jeffrey Weber, Karl D Lewis, et al.. 2022. “PIVOT-12: A Phase III Study of Adjuvant Bempegaldesleukin Plus Nivolumab in Resected Stage III/IV Melanoma at High Risk for Recurrence”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2021-1286.
clinicaltrials.govStudy
Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
2020. "Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04410445.
~161 spots leftby Apr 2025
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