SARCOMAPhase 2NCT03282344
A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma
A Phase 2 study testing NKTR-214 and Nivolumab in people with SARCOMA, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- SARCOMA
- What is being tested?
- NKTR-214 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Sep 2017to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
- † A woman of childbearing potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).
- Male patients with WOCBP partners and female patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 11.9, for the course of the study through 7 months (male participants) or 5 months (female participants) after the last dose of study medication.
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
- Hematological
- Absolute neutrophil count (ANC) ≥1,500 /mcL
- Platelets ≥100,000 / mcL
- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
- Renal
- Serum creatinine OR Measured or calculateda creatinine clearance ≤1.5 X upper limit of normal (ULN) OR ≥60 mL/min for patient with creatinine levels > 1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl) Hepatic
- Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for patients with liver metastases
- Albumin ≥ 2.5 mg/dL Coagulation
- International Normalized Ratio [34] or Prothrombin Time [35]≤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 aCreatinine clearance should be calculated per institutional standard.
Who cannot join
- 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:
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- 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.)
- History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 years prior to enrollment. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.
- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) disease
- Patients known to be positive for active Hepatitis B (HBsAg reactive), or Hepatitis C (HCV RNA (qualitative) is detected)
- Prolonged QTcF > 450 ms for men and > 470 ms for women at Screening.
- Patients who have received a live vaccine within 30 days of the start date of the planned study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Has a known history of active TB (Bacillus Tuberculosis)
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a known history of active TB (Bacillus Tuberculosis)
- Is currently participating and receiving study therapy or using an investigational device or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Note: Patients with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- Note: If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapies.
- Hypersensitivity to nivolumab or any of its excipients.
- Hypersensitivity to NKTR-214 or any of its excipients.
- Need for > 2 antihypertensive medications for management of hypertension (including diuretics).
- Women who are pregnant or breast feeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center (only recruiting to the Vascular/Angiosarcoma cohort)
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center (only recruiting to the Vascular/Angiosarcoma cohort)
New York, New York, 10065
About this study
Official title: A Pilot Study of NKTR-214 and Nivolumab in Selected Patients With Locally Advanced/Metastatic Sarcoma (CA209-9EM)
The purpose of this study is to test any good and bad effects of the combination of study drugs called NKTR-214 and nivolumab.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKTR-214Drug
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.
NivolumabDrug
360mg (flat dose) IV infusion administered over 30 (±5) minutes every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: NKTR-214; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start12 Sep 2017
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARCOMAStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Stanford University, Rockefeller University
- Responsible party
- Sponsor
- Investigators
- Sandra D'Angelo, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282344
- Sponsor's protocol ID
- 17-366
- Status last verified
- Jul 2026
- First submitted
- 12 Sep 2017
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 35710741
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of NKTR-214 and Nivolumab in Selected Patients With Locally Advanced/Metastatic Sarcoma (CA209-9EM)
- ClinicalTrials.gov ID
- NCT03282344
- Acronym / sponsor ID
- 17-366
- Conditions
- SARCOMA
- Keywords
- NKTR-214, NIVOLUMAB, 17-366
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Stanford University, Rockefeller University
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test any good and bad effects of the combination of study drugs called NKTR-214 and nivolumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| participants ≥18 years old NKTR-214 and Nivolumab | Experimental | Drug: NKTR-214, Drug: NivolumabNKTR-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. |
| participants 12 - 17 years old NKTR-214 0.006mg/kg and Nivo | Experimental | Drug: NKTR-214, Drug: NivolumabNKTR-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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (29 listed)
- 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.
Key exclusion criteria (32 listed)
- History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
- 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:
- Evidence of clinically significant immunosuppression such as the following:
- History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 years prior to enrollment. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NKTR-2140.006mg/kg IV on day 1 and every 3 weeks thereafter will be an intravenous (IV) infusion administered over 30 (±5) minutes every 3 weeks. | Drug | participants 12 - 17 years old NKTR-214 0.006mg/kg and Nivo, participants ≥18 years old NKTR-214 and Nivolumab |
| Nivolumab360mg (flat dose) IV infusion administered over 30 (±5) minutes every 3 weeks. | Drug | participants 12 - 17 years old NKTR-214 0.006mg/kg and Nivo, participants ≥18 years old NKTR-214 and Nivolumab |
Primary outcome
number of patients with a response
Time frame: 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Derived from this study: PubMed 35710741D'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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra D'Angelo, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NKTR-214 and Nivolumab in people with SARCOMA, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with a response (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.