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Cytokine

NKTR-262 for Breast Cancer (REVEAL Trial)

Phase 1 & 2
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 the dlt window is 21 days following nktr-262 single agent administration (cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (cohorts 1 and 2), or 7 days for the same day administration (cohort 3 and higher).
Awards & highlights

Summary

This trial is testing a new cancer treatment involving a combination of drugs. The first part of the trial will test different doses to find the best one, and the second part will test how well the treatment works in different groups of patients.

Eligible Conditions
  • Breast Cancer
  • Neuroendocrine Carcinoma
  • Colorectal Cancer
  • Melanoma
  • Head and Neck Squamous Cell Carcinoma
  • Sarcoma
  • Kidney Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the dlt window is 21 days following nktr-262 single agent administration (cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (cohorts 1 and 2), or 7 days for the same day administration (cohort 3 and higher).
This trial's timeline: 3 weeks for screening, Varies for treatment, and the dlt window is 21 days following nktr-262 single agent administration (cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (cohorts 1 and 2), or 7 days for the same day administration (cohort 3 and higher). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Experiencing Dose-Limiting Toxicities (DLTS)
Objective Response Rate (ORR) Per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D)

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Trial Design

1Treatment groups
Experimental Treatment
Group I: NKTR-262 + bempegaldesleukin or + bempegaldesleukin with nivolumabExperimental Treatment3 Interventions
Phase 1: NKTR-262 in escalating doses, combined with bempegaldesleukin. The goal of this dose escalation part of the study is to establish a recommended Phase 1b dose for NKTR-262 + bempegaldesleukin with nivolumab, followed by a dose-confirmation cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~4960

Find a Location

Who is running the clinical trial?

Nektar TherapeuticsLead Sponsor
58 Previous Clinical Trials
10,252 Total Patients Enrolled
2 Trials studying Breast Cancer
248 Patients Enrolled for Breast Cancer
Study DirectorStudy DirectorNektar Therapeutics
1,264 Previous Clinical Trials
503,424 Total Patients Enrolled
28 Trials studying Breast Cancer
9,124 Patients Enrolled for Breast Cancer
~9 spots leftby Oct 2025
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