DCC-3014 + Avelumab for Sarcoma

Recruiting in Palo Alto (17 mi)

Sandra P. D'Angelo, MD - MSK Sarcoma ...

Overseen bySandra D'Angelo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sandra D'Angelo, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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

See 8 more

Exclusion Criteria

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

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

See 3 more

Treatment Details

Interventions

Avelumab (Checkpoint Inhibitor)
DCC-3014 (Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

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

Avelumab is already approved in Japan for the following indications: