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

NCT03282344 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 17-366
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

SARCOMA

Keywords

NKTR-214; NIVOLUMAB; 17-366

Outcome Measures

Primary Outcomes (1)

• number of patients with a response

  Primary Response Criteria (RECIST 1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease \[1\]: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters whi le on study.

  2 years

Study Arms (2)

participants ≥18 years old NKTR-214 and Nivolumab

EXPERIMENTAL

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.

Drug: NKTR-214; Drug: Nivolumab

participants 12 - 17 years old NKTR-214 0.006mg/kg and Nivo

EXPERIMENTAL

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.

Drug: NKTR-214; Drug: Nivolumab

Interventions

NKTR-214 DRUG

0.006mg/kg IV on day 1 and every 3 weeks thereafter will be an intravenous (IV) infusion administered over 30 (±5) minutes every 3 weeks.

participants 12 - 17 years old NKTR-214 0.006mg/kg and Nivo; participants ≥18 years old NKTR-214 and Nivolumab

Nivolumab DRUG

360mg (flat dose) IV infusion administered over 30 (±5) minutes every 3 weeks.

participants 12 - 17 years old NKTR-214 0.006mg/kg and Nivo; participants ≥18 years old NKTR-214 and Nivolumab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age ≥ 12 years at the time of informed consent
• Be capable, willing, and able to provide written informed consent/assent. For patients \< 18 years of age, their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
• Be willing to comply with clinical trial instructions and requirements.
• Patients ≥ 18 years must be willing to comply with the mandatory biopsies.
• 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.
• Note: Patients with confirmed sarcoma with histologies not defined by the above cohorts will be enrolled into the "Other" cohort.
• Adequate performance status:
• Participants ≥16 years ECOG 0 or 1/KPS 100-70%
• Participants \<12-15 years Lanksky 100-70%
• Patients must have at least one prior line of systemic therapy (e.g.chemotherapy, immunotherapy, targeted or biological therapy) for their sarcoma if standard treatment is appropriate. Treatment naïve patients may be enrolled if they have refused standard systemic treatment. Prior adjuvant therapy will not count provided it was completed more than 6 months previously.
• Presence of measureable disease per RECIST v1.1.Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.
• On echocardiogram, documented left ventricular ejection fraction \>45%. Patients may instead have a multigated acquisition (MUGA) scan instead of transthoracic echocardiogram (TTE).
• Adequate organ function
• 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.

You may not qualify if:

• History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
• Unstable angina or myocardial infarction.
• Congestive heart failure (New York Heart Association \[NYHA\] Class III or IV).
• Uncontrolled clinically significant arrhythmias.
• Evidence of clinically significant interstitial lung disease or has known history of, or any evidence of active, non-infectious pneumonitis. .
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided:
• No current brain metastasis lesion greated than 2 cm. Patients with prior metastasis lesions greater than 2 cm that have been removed by surgical and/or radiotherapy may be enrolled if the lesion has been stable since surgery or radiotherapy.
• No new or progressing brain metastatis of any size
• No stereotactic radiation or craniotomy within 4 weeks of Cycle 1 Day 1
• They are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment
• No clinically signifigant symptoms secondary to brain metastases(This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.)
• Evidence of clinically significant immunosuppression such as the following:
• Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
• Concurrent opportunistic infection
• Receiving systemic immunosuppressive therapy (\> 2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within 2 months prior to enrollment. (Steroids for pre-medication for imaging studies are allowed.)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• M.D. Anderson Cancer Center: collaborator
• Stanford University: collaborator
• Rockefeller University: collaborator

Study Sites (2)

Memorial Sloan Kettering Cancer Center (only recruiting to the Vascular/Angiosarcoma cohort)

New York, New York, 10065, United States

Location

MD Anderson Cancer Center (only recruiting to the Vascular/Angiosarcoma cohort)

Houston, Texas, 77030, United States

Location

Related Publications (1)

• D'Angelo SP, Richards AL, Conley AP, Woo HJ, Dickson MA, Gounder M, Kelly C, Keohan ML, Movva S, Thornton K, Rosenbaum E, Chi P, Nacev B, Chan JE, Slotkin EK, Kiesler H, Adamson T, Ling L, Rao P, Patel S, Livingston JA, Singer S, Agaram NP, Antonescu CR, Koff A, Erinjeri JP, Hwang S, Qin LX, Donoghue MTA, Tap WD. Pilot study of bempegaldesleukin in combination with nivolumab in patients with metastatic sarcoma. Nat Commun. 2022 Jun 16;13(1):3477. doi: 10.1038/s41467-022-30874-8.

  PMID: 35710741 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Sarcoma

Interventions

bempegaldesleukin; Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sandra D'Angelo, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, multi-center, pilot study to evaluate the efficacy of NKTR- 214 in combination with nivolumab in patients with selected locally advanced/metastatic, high grade sarcoma.

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 13, 2017
• Study Start: September 12, 2017
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (2)