LiTT + Cemiplimab for Brain Cancer

Not yet recruiting at 1 trial location
OH
Overseen ByOmar H Butt, M.D., Ph.D.
Stay on Your Current MedsYou can continue your current medications while participating
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of combining two treatments, Laser Interstitial Thermal Therapy (LiTT) and cemiplimab (an immunotherapy drug), for individuals with recurrent glioblastoma, a type of brain cancer. Participants will receive either LiTT with cemiplimab or LiTT with standard chemotherapy selected by their doctor. This trial may suit those whose glioblastoma has returned after completing initial treatments such as surgery or chemotherapy. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received certain treatments like chemotherapy or radiation therapy within 2 weeks before starting the study treatment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Laser Interstitial Thermal Therapy (LiTT) is a safe option for treating brain tumors like glioblastomas. Research indicates that LiTT is minimally invasive, involving less cutting and being gentler on the body, which usually allows for a quick recovery. Patients often stay in the hospital for just 1-2 days after the procedure.

Cemiplimab, an immunotherapy drug already approved for certain types of cancer, has a well-understood safety profile. One study suggested that when used with LiTT, this combination is effective and generally well-tolerated by patients.

Overall, both LiTT alone and with cemiplimab have been reported as safe for patients, with manageable side effects. Always consult a healthcare provider to understand what this means for your specific situation.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Laser Interstitial Thermal Therapy (LiTT) and cemiplimab for brain cancer because it offers a novel approach by pairing a precise, heat-based method with a cutting-edge immunotherapy. Unlike standard treatments that often rely solely on chemotherapy or radiation, LiTT directly targets and destroys tumor tissue using laser-induced heat, minimizing damage to surrounding areas. Cemiplimab, an immune checkpoint inhibitor, works differently by unleashing the body's immune system to attack cancer cells. This dual approach could potentially enhance treatment effectiveness and improve outcomes for patients with brain cancer.

What evidence suggests that this trial's treatments could be effective for brain cancer?

Studies have shown that Laser Interstitial Thermal Therapy (LiTT) effectively treats brain tumors, including glioblastomas. This therapy uses a laser to heat and destroy tumor cells, extending life expectancy by about 2 months for some patients. Research indicates that LiTT can double survival rates for certain aggressive brain cancers, increasing the average survival time from 5.2 to 11.8 months. In this trial, participants in the experimental arm will receive LiTT combined with cemiplimab, an immune therapy, which may further enhance the body's ability to fight cancer cells. Meanwhile, participants in the control arm will receive LiTT followed by adjuvant chemotherapy. While LiTT is already a promising treatment, combining it with cemiplimab may lead to even better outcomes for patients with recurring glioblastoma.12345

Who Is on the Research Team?

OH

Omar H Butt, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with glioblastoma (a type of brain cancer) that has come back after treatment. Participants should be healthy enough for surgery and other treatments, and must not have conditions or medications that would interfere with the study.

Inclusion Criteria

I have grade 4 glioblastoma confirmed by biopsy, regardless of recurrence count.
I am able to care for myself and do most daily activities.
I understand the study and am willing to sign the consent form.
See 6 more

Exclusion Criteria

Pregnant or breastfeeding; people of childbearing potential must have negative pregnancy tests within 14 days of entry and within 72 hours of cemiplimab initiation if applicable
I have chronic hepatitis B and my viral load is undetectable with treatment.
I have hepatitis C that is not cured or still shows a detectable viral load.
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Laser Interstitial Thermal Therapy (LiTT) followed by adjuvant cemiplimab or chemotherapy

Up to 36 months
Every 3 weeks for cemiplimab, as per SOC for chemotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Extension/Long-term follow-up

Participants may continue to be monitored for progression-free survival and overall survival

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cemiplimab
  • Chemotherapy
  • Laser Interstitial Thermal Therapy (LiTT)

Trial Overview

The study compares two treatments: both groups get laser therapy to target the tumor, then one group gets cemiplimab (an immunotherapy drug), while the other gets a chemotherapy chosen by their doctor. Patients are randomly assigned in a 2:1 ratio.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Arm: LiTT + CemiplimabExperimental Treatment2 Interventions
Group II: Control Arm: LiTT + adjuvant chemotherapyActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

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George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

Efficacy of laser interstitial thermal therapy (LITT) for newly ...

The efficacy of LITT for the management of primary and metastatic brain tumors has not been evaluated in randomized clinical trials because of challenges with ...

Laser Interstitial Thermal Therapy (LiTT) With Cemiplimab ...

This study will assess the therapeutic efficacy of the combination of Laser Interstitial Thermal Therapy (LiTT) with adjuvant cemiplimab ...

Synergistic effects of laser interstitial thermal therapy (LITT) ...

Laser interstitial thermal therapy (LITT) has emerged as a promising minimally invasive technique for recurrent brain tumors. LITT utilizes a laser probe ...

Laser Interstitial Thermal Therapy Shows Promise for ...

MRI-guided laser interstitial thermal therapy appears to be safe and effective for glioblastomas and may add an average of 2 months to life expectancy.

Laser interstitial thermal therapy and adjuvant ...

LITT is a minimally invasive, MRI-guided thermal ablation technique for brain tumors. It is used to achieve effective cytoreduction with lower ...