Sintilimab for Angiosarcoma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 31

Duration: 24 months

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests sintilimab, an immunotherapy drug, in patients with advanced, metastatic, or recurrent angiosarcoma. Sintilimab helps the immune system recognize and attack cancer cells, aiming to control the disease.

Research Team

Vinod Ravi, M.D.

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults with advanced, metastatic, or recurrent angiosarcoma who have tried at least one chemotherapy and can't undergo more. They must be in relatively good health (ECOG <=1), have a measurable cancer lesion, expected to live at least 12 weeks, and agree to use effective contraception. Excluded are those previously treated with certain immunotherapies or suffering from conditions that could interfere with the trial.

Inclusion Criteria

I am using effective birth control and will continue for 6 months after the trial ends.

I've had a bad reaction or my cancer got worse after chemotherapy.

The amount of protein in your urine needs to be low.

Exclusion Criteria

If unsure about my eligibility, I will contact the sponsor with my full medical history.

I have been treated with specific drugs that target the immune system.

I have been on IV nutrition for less than 4 weeks due to severe malnutrition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sintilimab intravenously every 21 days for up to 24 months

24 months

1 visit every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Follow-up at 30 and 90 days, then every 60 days

Treatment Details

Interventions

• Sintilimab

Trial Overview The SiARa study is testing Sintilimab's effectiveness on angiosarcoma that has spread or returned after treatment. This phase II trial aims to see if this monoclonal antibody can help the immune system fight cancer by stopping tumor growth and spread.

Participant Groups

Group I: Treatment (sintilimab) Experimental Treatment 2 Interventions

Patients receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue to receive treatment at the discretion of the treating physician.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+