NCT04187872: TORCH

LITT and Pembrolizumab in Recurrent Brain Metastasis

Terminated Phase 1 Last updated 27 December 2023

What this trial tests

Phase 1 trial testing LITT + Pembrolizumab in Melanoma in 10 participants. Terminated before completion.

Timeline

10 January 2020

Primary endpoint
1 December 2023

1 December 2023

Quick facts

Lead sponsor	University of Florida
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	10 January 2020
Primary completion	1 December 2023
Estimated completion	1 December 2023
Sites	2 locations across United States

Drugs / interventions tested

• LITT + Pembrolizumab

Conditions studied

• Melanoma — all drugs for Melanoma →
• Non-small Cell Lung Carcinoma (NSCLC) — all drugs for Non-small Cell Lung Carcinoma (NSCLC) →
• Renal Cell Carcinoma (RCC) — all drugs for Renal Cell Carcinoma (RCC) →
• Small-cell Lung Cancer — all drugs for Small-cell Lung Cancer →

Sponsor

University of Florida

Who can join

Adults 18 to 100, any sex, with Melanoma or Non-small Cell Lung Carcinoma (NSCLC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, historically controlled pilot study investigating the immune effect of Laser Interstitial ThermotHerapy (LITT)+ pembrolizumab in adult patients with a primary cancer approved by the FDA for treatment with an immune-checkpoint inhibitor who have recurrent brain metastasis after prior stereotactic radiosurgery (SRS).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
2. Brain metastases: A Society for Neuro-Oncology (SNO) consensus review on current management and future directions.
   Aizer AA, Lamba N, Ahluwalia MS, Aldape K, et al · · 2022 · cited 116× · PMID 35762249 · DOI 10.1093/neuonc/noac118
3. Laser ablation: Heating up the anti-tumor response in the intracranial compartment.
   Lerner EC, Edwards RM, Wilkinson DS, Fecci PE. · · 2022 · cited 50× · PMID 35489652 · DOI 10.1016/j.addr.2022.114311
4. Emerging principles of brain immunology and immune checkpoint blockade in brain metastases.
   Fares J, Ulasov I, Timashev P, Lesniak MS. · · 2021 · cited 40× · PMID 33893488 · DOI 10.1093/brain/awab012
5. Immune deserts in head and neck squamous cell carcinoma: A review of challenges and opportunities for modulating the tumor immune microenvironment.
   Farlow JL, Brenner JC, Lei YL, Chinn SB. · · 2021 · cited 34× · PMID 34218062 · DOI 10.1016/j.oraloncology.2021.105420
6. Immunotherapy in NSCLC Patients with Brain Metastases.
   Buriolla S, Pelizzari G, Corvaja C, Alberti M, et al · · 2022 · cited 28× · PMID 35806080 · DOI 10.3390/ijms23137068
7. The intersection between immunotherapy and laser interstitial thermal therapy: a multipronged future of neuro-oncology.
   Srinivasan ES, Sankey EW, Grabowski MM, Chongsathidkiet P, et al · · 2020 · cited 24× · PMID 32672126 · DOI 10.1080/02656736.2020.1746413
8. Merkel Cell Carcinoma: An Immunotherapy Fairy-Tale?
   Tanda ET, d'Amato AL, Rossi G, Croce E, et al · · 2021 · cited 20× · PMID 34631574 · DOI 10.3389/fonc.2021.739006