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Combination Product

LITT + Pembrolizumab for Brain Cancer (TORCH Trial)

Phase 1
Waitlist Available
Led By David Tran, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose pembro to 30 days post final pembro dose
Awards & highlights

TORCH Trial Summary

This trial is testing a new cancer treatment combining two existing treatments. The goal is to see if the combination can help people with brain cancer who have already tried other treatments.

Who is the study for?
Adults with certain FDA-approved primary cancers who have recurrent brain metastasis after prior radiosurgery can join. They must be suitable for LITT and pembrolizumab, have up to five new or growing lesions under 3.5 cm accessible by laser probe, able to undergo MRI scans, and a KPS score of at least 70. Participants need effective contraception and cannot have active hepatitis B/C, HIV, TB, uncontrolled illnesses or be on immunosuppressive therapy.Check my eligibility
What is being tested?
The trial is testing the combination of Laser Interstitial ThermotHerapy (LITT) with pembrolizumab in patients whose brain cancer has returned despite previous treatment. It aims to see how this combo affects the immune system's response against cancer.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs including lungs (pneumonitis), liver issues, skin reactions, hormone gland problems (like thyroid dysfunction), and infusion-related reactions.

TORCH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose pembro to 30 days post final pembro dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose pembro to 30 days post final pembro dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immune Effect of LITT plus pembrolizumab
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) of LITT plus pembrolizumab

TORCH Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with Recurrent Brain MetastesExperimental Treatment1 Intervention
Adult patients with a primary cancer approved by the FDA for treatment with an immune-checkpoint inhibitor who have recurrent brain metastasis that have failed SRS treatment will receive LITT per standard of care in combination with Pembrolizumab 200mg IV every 3 weeks (+/-3 days) up to 2 years.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,695 Total Patients Enrolled
Monteris MedicalIndustry Sponsor
9 Previous Clinical Trials
1,610 Total Patients Enrolled
David Tran, PhDPrincipal InvestigatorUniversity of Florida

Media Library

Pembrolizumab (Combination Product) Clinical Trial Eligibility Overview. Trial Name: NCT04187872 — Phase 1
Bladder Cancer Research Study Groups: Patients with Recurrent Brain Metastes
Bladder Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04187872 — Phase 1
Pembrolizumab (Combination Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04187872 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is the combination of LITT and Pembrolizumab potentially risky?

"Due to the limited data available on its safety and efficacy, our team at Power gave LITT + Pembrolizumab a score of 1."

Answered by AI

How many participants is this clinical experiment enlisting?

"Affirmative. Clinicaltrials.gov's records demonstrate that this research project, which was initially launched on January 10th 2020, is actively recruiting participants. This study requires 16 patients to be enrolled from 2 distinct sites."

Answered by AI

What other investigations have explored the dynamics of LITT and Pembrolizumab?

"Currently, 961 trials utilizing LITT + Pembrolizumab are underway with 122 in Phase 3. Although several of these research studies are based out of Houston, Texas, there is a total of 35731 sites all around the world conducting this trial."

Answered by AI

Who is eligible to participate in this research endeavor?

"To be considered for this trial, applicants must have been diagnosed with melanoma and must fall between the ages of 18 to 100. A total of 16 participants are needed."

Answered by AI

Are there vacancies in this medical trial for prospective participants?

"Affirmative. Per the data available on clinicaltrials.gov, this investigation is currently recruiting participants as of August 22nd 2022. This trial was initially posted on October 1st 2020 and requires 16 individuals from 2 separate sites to take part in the research."

Answered by AI

Does the trial accept geriatric participants?

"This medical trial is seeking participants aged 18 to 100 years old."

Answered by AI

What kind of symptoms does the combination of LITT and Pembrolizumab aim to reduce?

"Patients with malignant neoplasms are commonly treated with a combination of LITT and Pembrolizumab. This therapy is also beneficial for individuals suffering from unresectable melanoma, microsatellite instability high, or chemotherapy-induced progression."

Answered by AI
~2 spots leftby Apr 2025