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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

REVEAL Trial 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

REVEAL Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

REVEAL 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
10,278 Total Patients Enrolled
2 Trials studying Breast Cancer
248 Patients Enrolled for Breast Cancer
Study DirectorStudy DirectorNektar Therapeutics
1,207 Previous Clinical Trials
489,616 Total Patients Enrolled
28 Trials studying Breast Cancer
9,124 Patients Enrolled for Breast Cancer

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
REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies
2018. "REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03435640.
~9 spots leftby Apr 2025
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