Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas

NCT04242238 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 19-340
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to find the safest dose of DCC-3014 that can be given with avelumab to participants with advanced or metastatic sarcomas that will not cause serious side effects.

Conditions

Sarcoma; Advanced Sarcoma; High Grade Sarcoma; Leiomyosarcoma; Undifferentiated Pleomorphic Sarcoma; Myxofibrosarcoma; Dedifferentiated Liposarcoma

Keywords

Advanced High Grade Sarcoma; CSF1R Inhibitor; DCC-3014; Anti-PD-L1 Antibody; Anti-PD-L1; Avelumab; Memorial Sloan Kettering Cancer Center; 19-340; Leiomyosarcoma; Undifferentiated Pleomorphic Sarcoma; Myxofibrosarcoma; Dedifferentiated Liposarcoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  Identify the maximum tolerated dose (MTD) by evaluating toxicity using NCI CTCAE (version 4.03)

  1 year

• Overall Response Rate

  Best overall response rate (CR+PR) based on RECIST v1.1

  48 weeks

Study Arms (1)

Advanced High-grade Sarcoma

EXPERIMENTAL

Dose Escalation: Up to 18 pts with locally advanced or metastatic high-grade sarcomas Dose Expansion: 10 pts per each diagnosis - undifferentiated pleomorphic sarcoma or myxofibrosarcoma, Leiomyosarcoma, Dedifferentiated liposarcoma

Drug: DCC-3014; Drug: Avelumab

Interventions

DCC-3014 DRUG

DCC-3014 will be administered in pill form. Start Day 1 on first cycle and continue with dosing of DCC-3014.

Advanced High-grade Sarcoma

Avelumab DRUG

Start Day 1 on first cycle with further infusions of avelumab every 14 days

Advanced High-grade Sarcoma

Eligibility Criteria

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

You may qualify if:

• Age \>/= 18 years at the time of informed consent
• Be capable, willing, and able to provide written informed consent/assent
• Be willing to comply with clinical trial instructions and requirement, including mandatory biopsies
• Dose escalation phase: Patients must have a histologically confirmed metastatic and/or locally advanced high grade sarcoma
• Dose expansion phase: Patients must have a histologically confirmed metastatic and/or locally undifferentiated pleomorphic sarcoma, myxofibrosarcoma, leiomyosarcoma, or dedifferentiated liposarcoma
• Adequate performance status: ECOG 0 or 1/KPS 100-70%
• Patients must have at least one prior line of systemic therapy (e.g. chemotherapy, targeted or biological therapy) for their sarcoma. Prior neoadjuvant and/or adjuvant therapy will count regardless of when it was completed. Treatment naïve patients can enroll if they refuse standard of care systemic chemotherapy.
• Presence of measurable 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
• Adequate organ function determined within 28 days of treatment initiation, as defined in Table 3:
• 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 calculated (Creatinine clearance should be calculated per institutional standard) creatinine clearance (GFR can also be used in place of creatinine or CrCl):
• ≤ 1.5 x upper limit of normal (ULN) OR ≥ 60 mL/min for patient with creatinine levels \> 1.5 x institutional ULN
• 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 patient with liver metastases Albumin: ≥ 2.5mg/dL
• Coagulation Internalized Normalized Ratio (INR) or Prothrombin Time (PT): ≤ 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

You may not qualify if:

• History of unstable or deteriorating cardiovascular disease within the previous 6 months prior to screening including but not limited to the following:
• Unstable angina or myocardial infarction
• CVA/stroke
• Congestive heart failure (New York Heart Association \[NYHA\] Class III or IV)
• Uncontrolled clinically significant arrhythmias
• Evidence or clinically significant interstitial lung disease or active, noninfectious pneumonitis related to prior immunotherapy treatment
• Malabsorption syndrome or other illness that could affect oral absorption
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases or carcinomatous meningitis may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 day prior to trial treatment
• Current use of immunosuppressive medication, EXCEPT for the following:
• intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
• Systemic corticosteroids at physiologic doses \</= 10mg/day of prednisone or equivalent
• Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
• Evidence of clinically significant immunosuppression such as the following:
• Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
• Concurrent opportunistic infection

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• ENABLE MEDICINE: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Sarcoma; Leiomyosarcoma; Histiocytoma, Malignant Fibrous; Dermatofibrosarcoma; Liposarcoma

Interventions

avelumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Fibrosarcoma; Neoplasms, Adipose Tissue

Study Officials

• Sandra D'Angelo, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Standard 3+3 design

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: January 22, 2020
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)