NKTR-214 + Nivolumab for Sarcoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Sandra D'Angelo, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test any good and bad effects of the combination of study drugs called NKTR-214 and nivolumab.

Research Team

Sandra D'Angelo, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I am 12 years old or older.

Coagulation: International Normalized Ratio or Prothrombin Time ≤1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening and ≤ 72 hours prior to day 1 of study treatment. If the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Exclusion Criteria

Hypersensitivity to NKTR-214 or any of its excipients.

I am not pregnant or breastfeeding.

I have had an autoimmune disease that needed treatment in the last 2 years.

Treatment Details

Interventions

• Nivolumab (Checkpoint Inhibitor)
• NKTR-214 (Immunotherapy)

Trial Overview 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.

Participant Groups

Group I: participants ≥18 years old NKTR-214 and Nivolumab Experimental Treatment 2 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 Nivo Experimental Treatment 2 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.

Nivolumab is already approved in Canada, Switzerland for the following indications:

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Rockefeller University

Collaborator

Trials

162

Recruited

16,700+

Richard P. Lifton

Rockefeller University

Chief Executive Officer since 2016

MD, PhD

Barry S. Coller

Rockefeller University

Chief Medical Officer since 2016

MD

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD