A Study of Etrumadenant and Zimberelimab in People With Dedifferentiated Liposarcoma

NCT05886634 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 22-277
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 7

Brief Summary

Participants will have a diagnosis of dedifferentiated liposarcoma (DDLS) that has spread beyond its original location (advanced). In addition, their DDLS either has come back after treatment (recurrent), has spread to different parts of your body (metastatic), or is unable to be removed surgically (unresectable). The purpose of this study is to find out whether the combination of etrumadenant and zimberelimab is an effective treatment for people with advanced DDLS.

Conditions

Dedifferentiated Liposarcoma; Soft Tissue Sarcoma; Sarcoma,Soft Tissue; Sarcoma; Recurrent Dedifferentiated Liposarcoma; Unresectable Dedifferentiated Liposarcoma; Metastatic Dedifferentiated Liposarcoma

Keywords

Dedifferentiated Liposarcoma; Recurrent Dedifferentiated Liposarcoma; Unresectable Dedifferentiated Liposarcoma; Metastatic Dedifferentiated Liposarcoma; Soft Tissue Sarcoma; Sarcoma, Soft Tissue; Sarcoma; DDLPS; Memorial Sloan Kettering Cancer Center; 22-277

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  To estimate the overall response rate (CR + PR per RECIST 1.1) to etrumadenant combined with zimberelimab at 24 weeks in patients with advanced Dedifferentiated Liposarcoma/DDLPS

  24 weeks

Study Arms (1)

Participants With Dedifferentiated Liposarcoma/DDLPS

EXPERIMENTAL

Participants will have a diagnosis of recurrent or metastatic Dedifferentiated Liposarcoma/DDLPS

Drug: Etrumadenant; Drug: Zimberelimab

Interventions

Etrumadenant DRUG

Will be administered PO daily for 24 weeks

Participants With Dedifferentiated Liposarcoma/DDLPS

Zimberelimab DRUG

Will be administered IV every 2 weeks for 24 weeks

Participants With Dedifferentiated Liposarcoma/DDLPS

Eligibility Criteria

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

You may qualify if:

• Diagnosis of recurrent, unresectable, or metastatic DDLPS
• The definition of recurrent disease is a patient with a primary tumor that has been successfully resected, but has recurred after primary surgery
• Any number of prior systemic therapies will be allowed
• Age ≥ 18 years at the time of informed consent
• Willing and able to provide written informed consent/assent for the trial
• Willing to comply with treatment protocol
• Adequate performance status: Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1/Karnofsky Performance Status (KPS) 70-100%
• Presence of measurable disease per RECIST v1.1
• o Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression
• QTc ≤ 480 msec using Fredericia's QT correction formula
• Adequate organ function determined within 2 weeks of treatment initiation, defined as follows:
• Hemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count ≥ 1,500/mm3 (1.0 x 109/L)
• Platelet count ≥ 75,000/mm3 (50 x 109/L)
• Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for a patient with total bilirubin level \> 1.5 x ULN

You may not qualify if:

• Patients who fulfil any of the following criteria are not eligible for admission to the study:
• Prior treatment with systemic PD-1 or PD-L1 inhibitor
• Prior treatment with an agent targeting the adenosine pathway
• Have a concurrent unrelated malignancy that requires active treatment
• o Patients with concurrent malignancies of a different tumor whose natural history or treatment will likely not interfere with the safety or efficacy assessment of the investigational drug will be eligible
• Uncontrolled intercurrent illness including active infection requiring systemic therapy or symptomatic congestive heart failure within the past 6 months
• Has known active central nervous system (CNS) metastases
• Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to study Day 1 and return to baseline of neurologic symptoms), and have no evidence of new or enlarging brain metastases. This exception does not include sarcomatous meningitis, which is excluded regardless of clinical stability.
• Patients must be on a stable or decreasing corticosteroid dose at the time of study entry; patients who require escalating doses of corticosteroids for the treatment of CNS metastases will be excluded.
• Shows 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 14 days prior to enrollment. However, in the setting of non-immune mediated indications for use, chronic/active low dose steroid use may be permitted at the discretion of the principal investigator.
• Has a known infection with HIV AND
• CD4+ T-cell (CD4+) counts \< 350 cells/uL

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553, United States

Location

MeSH Terms

Conditions

Liposarcoma; Sarcoma

Interventions

zimberelimab

Condition Hierarchy (Ancestors)

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

Study Officials

• Sandra D'Angelo, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): May 23, 2027
• Study Completion (Estimated): May 23, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (7)