LiTT + Cemiplimab for Brain Cancer
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Laser Interstitial Thermal Therapy (LiTT) followed by adjuvant cemiplimab or chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension/Long-term follow-up
Participants may continue to be monitored for progression-free survival and overall survival
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
Patients in the Experimental Arm will receive adjuvant cemiplimab (at a dose of 350 mg intravenously (IV)) every 3 weeks after LiTT for a maximum total of 36 months (or until disease progression or intolerable adverse event). The first adjuvant dose of cemiplimab must be given within 14 days post-LiTT.
Patients in the Control Arm will undergo LiTT, then will receive adjuvant chemotherapy (chosen by their treating physician) for up to 12 months as per standard of care (SOC), starting within 14 days post-LiTT.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
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 ...
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cancernetwork.com
cancernetwork.com/view/laser-interstitial-thermal-therapy-shows-promise-glioblastomasLaser 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 ...
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