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Checkpoint Inhibitor

NKTR-214 + Nivolumab for Sarcoma

Phase 2

Waitlist Available

Led By Sandra D'Angelo, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a histologically confirmed metastatic and/or locally advanced sarcoma by the enrolling institution.

For histological specific cohorts, patients must have confirmed metastatic and/or locally advanced osteosarcoma, chondrosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma high grade myxofibrosarcoma (UPS/MFH/MFS), vascular sarcoma, alveolar soft part sarcoma (ASPS), dedifferentiated/pleomorphic liposarcoma, Small Blue Round CellSynovial, or leiomyosarcoma (LMS) by the enrolling institution.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing the effects of a new drug combination to see if it is safe and effective.

Who is the study for?

Adults and children (12 years and older) with various types of advanced sarcoma who have already tried at least one systemic therapy can join this trial. They must be in good health otherwise, with proper organ function, no severe heart issues or lung disease, not pregnant or breastfeeding, and willing to use contraception.Check my eligibility

What is being tested?

The study is testing the combination of two drugs: NKTR-214 and Nivolumab. These are given to patients with metastatic or locally advanced sarcoma to see if they work better together than existing treatments.See study design

What are the potential side effects?

Possible side effects include immune-related reactions that could affect different organs, flu-like symptoms from NKTR-214, fatigue, skin problems like rash or itchiness from Nivolumab, as well as potential risks common to cancer immunotherapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My sarcoma is confirmed to be advanced or has spread, as verified by tests.

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My cancer is a specific type and has spread or is advanced.

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I am 16 or older with good physical health or I am 12-15 years old with a good ability to carry out daily activities.

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I am willing to use birth control during and up to 5-7 months after the study.

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My kidney function, measured by creatinine or GFR, is within the normal range.

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My organs are working well.

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I am over 18 and agree to undergo all required biopsies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

number of patients with a response

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%

Headache

15%

Vomiting

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

Pneumonitis

Myocarditis

Pleural effusion

Dysphagia

General physical health deterioration

Autoimmune colitis

Infection

Urinary tract infection

Syncope

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: participants ≥18 years old NKTR-214 and NivolumabExperimental Treatment2 Interventions

NKTR-214 0.006mg/kg and nivolumab 360mg will be administered intravenously on day 1 of week 1 of cycle one and every 3 weeks (±3 days) thereafter.

Group II: participants 12 - 17 years old NKTR-214 0.006mg/kg and NivoExperimental Treatment2 Interventions

NKTR-214 0.006mg/kg and nivolumab 360mg will be administered intravenously on day 1 of week 1 of cycle one and every 3 weeks (±3 days) thereafter.

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterOTHER

2,967 Previous Clinical Trials

1,804,714 Total Patients Enrolled

55 Trials studying Sarcoma

18,165 Patients Enrolled for Sarcoma

Rockefeller UniversityOTHER

158 Previous Clinical Trials

16,269 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,534 Total Patients Enrolled

70 Trials studying Sarcoma

13,679 Patients Enrolled for Sarcoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03282344 — Phase 2

Sarcoma Research Study Groups: participants ≥18 years old NKTR-214 and Nivolumab, participants 12 - 17 years old NKTR-214 0.006mg/kg and Nivo

Sarcoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03282344 — Phase 2

Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03282344 — Phase 2

Frequently Asked Questions

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

Are individuals being accepted to join this research study?

"Unfortunately, this specific trial is now closed for recruitment. The posting date was September 12th 2017 and the last update occured on May 6th 2022. For those looking for other trails related to sarcoma, 443 studies are actively recruiting participants whilst 720 trials are accepting new patients interested in NKTR-214 treatment."

Answered by AI

What is the maximum participant capacity for this clinical research endeavor?

"This trial is no longer recruiting patients. The first posting was on September 12th 2017, with the last update occuring on May 6th 2022. There are currently 443 clinical trials for sarcoma and 720 studies related to NKTR-214 that are actively accepting enrollees."

Answered by AI

What conditions are addressed by NKTR-214 treatment?

"NKTR-214 is a medical intervention with potential to mitigate the effects of malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Is this experimental study the inaugural foray into its field of research?

"Currently, there are 720 ongoing studies for NKTR-214 spanning 2355 cities and 49 nations. Ono Pharmaceutical Co Ltd was the initial sponsor of a trial involving 659 individuals in 2012 which successfully completed its Phase 1 & 2 clinical trials process. Since then, an additional 254 examinations have been conducted on this drug."

Answered by AI

Has NKTR-214 received the requisite governmental sanction to be used medicinally?

"Our team at Power gauged the safety of NKTR-214 to be a 2, due to its status as an experimental drug in Phase 2 testing. This implies that there is some evidence for safety, but none yet regarding efficacy."

Answered by AI

Have any other investigations made use of NKTR-214?

"NKTR-214 was initially tested at Local Institution back in 2012, with a cumulative of 254 finished studies. At present, there are 720 active investigations - many conducted from the environs of New york City."

Answered by AI

Recent research and studies

Nature CommunicationsJournal

Pilot Study of Bempegaldesleukin in Combination with Nivolumab in Patients with Metastatic Sarcoma

D’Angelo, Sandra P., Allison L. Richards, Anthony P. Conley, Hyung Jun Woo, Mark A. Dickson, Mrinal Gounder, Ciara Kelly, et al.. 2022. “Pilot Study of Bempegaldesleukin in Combination with Nivolumab in Patients with Metastatic Sarcoma”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/s41467-022-30874-8.

clinicaltrials.govStudy

A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma

2017. "A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03282344.