What side effects are associated with this type of intervention?

Common treatments for sarcoma, such as CSF1R inhibitors and PD-L1 inhibitors, are associated with a range of side effects. For PD-L1 inhibitors like Avelumab, common adverse events include skin reactions, endocrine events, and immune-related effects such as pneumonitis and hepatitis. CSF1R inhibitors, while less commonly detailed, may share similar immune-related side effects. Additionally, treatments like pazopanib, sorafenib, and sunitinib, which target tyrosine kinase pathways, often result in severe adverse effects such as fatigue, hypertension, diarrhea, anorexia, and liver function abnormalities.

What prior FDA approvals exist?

The FDA has approved several treatments for sarcoma, including immune checkpoint inhibitors and targeted therapies. Avelumab, a PD-L1 inhibitor, has been approved for metastatic Merkel cell carcinoma and is being studied in combination with other agents for sarcoma. While specific FDA approvals for CSF1R inhibitors like DCC-3014 in sarcoma are not detailed, the ongoing research highlights the potential of combining immune checkpoint inhibitors with other targeted therapies to improve outcomes in sarcoma patients.

What other types of research exist?

Promising novel alternatives for sarcoma patients include: 1) Pembrolizumab (PD-1 inhibitor), which has shown activity in advanced bone and soft tissue sarcomas in the SARC028 trial. 2) Nivolumab (PD-1 inhibitor), which has demonstrated efficacy in various sarcoma subtypes, including in combination with ipilimumab (CTLA-4 inhibitor). 3) Tremelimumab (CTLA-4 inhibitor), although its efficacy in mesothelioma was not significant, it may still be considered in combination therapies. These alternatives have shown potential in clinical trials and could be considered for treatment in 2024.

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Checkpoint Inhibitor

DCC-3014 + Avelumab for Sarcoma

Phase 1

Waitlist Available

Led By Sandra D'Angelo, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safest dose of a new drug, DCC-3014, combined with an existing drug, avelumab, for patients with advanced or spreading sarcomas. The goal is to find a dose that fights cancer without causing serious side effects. Avelumab has been effective in treating various types of cancer.

Who is the study for?

Adults (18+) with advanced or metastatic sarcomas, specifically undifferentiated pleomorphic, myxofibrosarcoma, leiomyosarcoma, or dedifferentiated liposarcoma. Participants must have had at least one prior systemic therapy and show measurable disease progression. They should be in good health otherwise and willing to use effective contraception.

What is being tested?

The trial is testing the combination of DCC-3014 with Avelumab to determine the safest dose for treating advanced sarcomas without causing severe side effects. The study involves participants who meet specific criteria related to their cancer type and previous treatments.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects for drugs like DCC-3014 and Avelumab may include fatigue, infusion reactions, immune-related conditions such as thyroid disorders or pneumonitis, skin rash, nausea, and increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose

Overall Response Rate

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848

17%

Musculoskeletal and connective tissue disorders

11%

Injury, poisoning and procedural complications

Metabolism and nutrition disorders

Nervous system disorders

Endocrine disorders

General disorders and administration site conditions

Investigations

Cardiac disorders

Gastrointestinal disorders

Infections and infestations

Immune system disorders

Blood and lymphatic system disorders

Neoplasms benign, malignant and unspecified

Respiratory, thoracic and mediastinal disorders

Renal and urinary disorders

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Avelumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Advanced High-grade SarcomaExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

2017

Completed Phase 2

~2440

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for sarcoma include surgery, radiation therapy, chemotherapy, and emerging immunotherapies. Surgery and radiation aim to remove or destroy the tumor locally. Chemotherapy uses drugs to kill rapidly dividing cancer cells. Immunotherapies, such as DCC-3014 and Avelumab, represent a newer approach. DCC-3014 is a CSF1R inhibitor that targets the tumor microenvironment by inhibiting macrophages that support tumor growth. Avelumab is a PD-L1 inhibitor that helps the immune system recognize and attack cancer cells by blocking the PD-L1 protein, which tumors use to evade immune detection. These treatments are significant for sarcoma patients as they offer new avenues for targeting the disease, especially in advanced or metastatic cases where traditional therapies may be less effective.

Uncommon and peculiar soft tissue sarcomas: Multidisciplinary review and practical recommendations. Spanish Group for Sarcoma research (GEIS -GROUP). Part II.Is immunotherapy in the future of therapeutic management of sarcomas?Facts and Hopes in Immunotherapy of Soft-Tissue Sarcomas.