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Checkpoint Inhibitor

NKTR-214 for Melanoma

Phase 3

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

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 from date of randomization to date of death (up to 37 months)

Awards & highlights

Study Summary

This trial is testing a new drug, NKTR-214, to see if it is effective in treating melanoma that cannot be removed by surgery or has spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization to date of death (up to 37 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization to date of death (up to 37 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization to date of death (up to 37 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

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)

Overall Survival (OS)

Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)

Secondary outcome measures

Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)

Clinical Benefit Rate (CBR) Per Investigator

Duration of Response (DoR) Per Blinded Independent Central Review (BICR)

+10 more

Side effects data

From 2023 Phase 3 trial • 783 Patients • NCT03635983

37%

Pyrexia

31%

Fatigue

29%

Pruritus

26%

Rash

26%

Nausea

21%

Arthralgia

21%

Diarrhoea

18%

Influenza like illness

18%

Hypothyroidism

16%

Asthenia

15%

Vomiting

15%

Headache

15%

Decreased appetite

14%

Anaemia

13%

Myalgia

13%

Eosinophilia

12%

Cough

12%

Hyperthyroidism

12%

Infusion related reaction

10%

Oedema peripheral

10%

Dizziness

Chills

Hypotension

Pain in extremity

Malignant neoplasm progression

Back pain

Constipation

Insomnia

Alanine aminotransferase increased

Rash maculo-papular

Abdominal pain

Dyspnoea

Dry skin

Erythema

Abdominal pain upper

Aspartate aminotransferase increased

Vitiligo

Hypertension

Blood creatine phosphokinase increased

Lipase increased

Amylase increased

Blood creatinine increased

Cerebrovascular accident

Acute kidney injury

Infection

Urinary tract infection

Syncope

Pneumonitis

Myocarditis

Pleural effusion

Dysphagia

General physical health deterioration

Autoimmune colitis

Malignant pleural effusion

Angina pectoris

Face oedema

Gastroenteritis

Pneumonia

Hyponatraemia

Pulmonary embolism

Cellulitis

Skin infection

Groin pain

Sepsis

Colitis

Disease progression

Respiratory failure

COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Bempegaldesleukin + Nivolumab

Nivolumab

Trial Design

2Treatment groups

Experimental Treatment

Group I: MonotherapyExperimental Treatment1 Intervention

Nivolumab

Group II: CombinationExperimental Treatment2 Interventions

NKTR-214 + Nivolumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NKTR-214

2018

Completed Phase 3

~820

Nivolumab

2014

Completed Phase 3

~4750

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,639 Previous Clinical Trials

4,128,249 Total Patients Enrolled

177 Trials studying Melanoma

56,760 Patients Enrolled for Melanoma

Nektar TherapeuticsIndustry Sponsor

58 Previous Clinical Trials

9,559 Total Patients Enrolled

4 Trials studying Melanoma

1,386 Patients Enrolled for Melanoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03635983 — Phase 3

Melanoma Research Study Groups: Combination, Monotherapy

Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03635983 — Phase 3

Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03635983 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When will NKTR-214 be available for public consumption?

"There is already some evidence of efficacy, and multiple trials have shown that NKTR-214 is safe, so it received a score of 3."

Answered by AI

Does this research project have a global or local reach?

"While this study is primarily based out of three locations - Local Institution - 0018 in Boston, Massachusetts, Local Institution in Fridley, Minnesota, and Local Institution - 0188 in Ann Arbor, Michigan - it is also taking place at 58 other sites."

Answered by AI

For what type of ailment is NKTR-214 most often recommended?

"NKTR-214 is most often used to help patients with malignant neoplasms, but it can also be used to manage unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Are there any volunteers currently needed for this research project?

"The clinicaltrials.gov website indicates that this study has already completed recruitment. This trial was first posted on September 21, 2018 and was last updated on October 25, 2022. Although this study is not taking any more patients, there are 1,532 other trials that are still recruiting."

Answered by AI

Has a similar trial been conducted before?

"Since 2010, NKTR-214 has been under scientific investigation with the first Phase 1 drug trial involving 127 people. The study was sponsored by Medarex and completed in 2010. Afterwards, the medication received its Phase 1 drug approval. Now, there are 753 live studies being conducted for NKTR-214 across 2357 cities in 50 countries."

Answered by AI

Are there any other previous examples of NKTR-214 being tested in a controlled setting?

"The first study for NKTR-214 was completed in 2010. There have been a total of 242 studies completed as of now. Right now, there are 753 trials in progress, with a high concentration in the Boston area."

Answered by AI

How many total people are in this research project?

"Unfortunately, this particular study is no longer recruiting patients. It was originally posted on September 21st, 2018 but the last update was on October 25th, 2020. There are, however, 779 other trials concerning melanoma and 753 clinical trials involving NKTR-214 that are still actively looking for participants."

Answered by AI