Apply to Trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

32 Participants Needed

Pembrolizumab for Sarcoma

Recruiting at 5 trial locations

Overseen ByLauren Banks, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Immunodeficiency, Autoimmune disease, others

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

Prior Safety DataThis treatment has passed at least one previous human trial

Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests pembrolizumab, a drug that aids the immune system in fighting cancer, as a treatment for certain types of sarcomas, which are rare cancers. Researchers aim to determine if the drug is effective and causes only mild side effects. Participants must have a confirmed diagnosis of pleomorphic liposarcoma, PEComa, epithelioid sarcoma, CIC-rearranged sarcoma, or sclerosing epithelioid fibrosarcoma, with cancer that has recurred or spread and lacks other treatment options. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on certain treatments like systemic steroids or have had recent cancer therapies. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that pembrolizumab is likely to be safe for humans?

A previous study found that pembrolizumab had a manageable safety profile in patients with rare and ultra-rare types of sarcoma. Common serious side effects included anemia (low red blood cell count), affecting about 8% of patients, and increased liver enzymes, seen in 6% of patients. These side effects, while significant, are considered manageable.

For those with epithelioid sarcoma, pembrolizumab proved effective and maintained a similar safety profile. Research on sclerosing epithelioid fibrosarcoma and low-grade fibromyxoid sarcoma shows that pembrolizumab is generally well-tolerated, with mostly mild to moderate side effects.

In PEComa (a type of tumor), pembrolizumab has been associated with stable disease over a long time, suggesting it works well without causing severe side effects. For CIC-rearranged sarcoma, the treatment's safety was consistent with previous trials, with only 5% of patients experiencing serious issues.

Finally, in pleomorphic liposarcoma, pembrolizumab, when used with other treatments, improved outcomes and was generally safe, indicating it can be a valid option without major risks.

Overall, pembrolizumab has been tested in various rare sarcomas, showing a consistent safety profile. Side effects are usually mild or manageable, making it a potentially safe option for patients considering joining this trial.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising for sarcoma?

Pembrolizumab stands out because it harnesses the power of the immune system to tackle sarcoma, unlike traditional chemotherapy or radiation treatments. It works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. This mechanism helps the body’s natural defenses recognize and fight the cancer more effectively. Researchers are excited about pembrolizumab's potential to offer a more targeted approach with possibly fewer side effects, providing new hope for patients with challenging sarcomas.

What evidence suggests that pembrolizumab might be an effective treatment for sarcoma?

Research has shown that pembrolizumab can help treat certain types of sarcomas, which are rare cancers. In this trial, participants will receive pembrolizumab for various sarcoma types. For epithelioid sarcoma, about 6.2% of patients respond to the treatment, with an average survival time of 19.7 months. In sclerosing epithelioid fibrosarcoma and low-grade fibromyxoid sarcoma, some patients have responded well, experiencing different durations before disease progression. Pembrolizumab has also shown promise in treating PEComa, with some patients experiencing stable disease after treatment. In CIC-rearranged sarcoma, about 34.3% of patients respond to the treatment, with some experiencing survival benefits. For pleomorphic liposarcoma, combining pembrolizumab with other treatments has improved the time patients remain disease-free. These findings suggest that pembrolizumab may enhance the immune system's ability to fight these rare sarcomas.² ³ ⁶ ⁷ ⁸

Who Is on the Research Team?

Robert Maki, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with specific ultra-rare sarcomas, including epithelioid sarcoma, pleomorphic liposarcoma, PEComa, and others. Participants must have recurrent or metastatic disease that isn't curable by other means and should have shown progression after their most recent therapy. They need measurable disease as defined by RECIST 1.1.

Inclusion Criteria

My condition is epithelioid sarcoma.

My cancer has worsened after the last treatment according to my doctor.

My condition is pleomorphic liposarcoma.

See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab Q 6 weeks IV infusion for ultra-rare sarcomas

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

Pembrolizumab

Trial Overview

The study tests Pembrolizumab's effectiveness and side effects in treating ultra-rare sarcomas. It's a PD-1 inhibitor drug that boosts the immune system to fight cancer by blocking a protein that normally restrains it.

How Is the Trial Designed?

Treatment groups

Experimental Treatment

Group I: Sclerosing epithelioid fibrosarcoma - low grade fibromyxoid sarcomaExperimental Treatment1 Intervention