Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Anti-Infective Agents

Analgesics

Antibodies

Antibodies, Monoclonal

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Pembrolizumab

Aldesleukin

Immunomodulating Agents

Immunoglobulins

Muromonab-CD3

Interleukin-2

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Analgesics, Non-Narcotic

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

All patients will receive LN-144 therapy, consisting of these steps:

1. Harvest (surgical resection of tumor tissue) to provide the autologous tissue that serves as the source of LN-144.
2. Production of LN-144 investigational product (IP) at a central Good Manufacturing Practice (GMP) facility
3. A 5-day nonmyeloablative lymphodepletion (NMA-LD) preparative regimen
4. Infusion of the LN-144 product (Day 0)
5. Administration of IV interleukin-2 (IL-2) for ≤ 6 doses.
6. Infusion of pembrolizumab 200 mg (Week 12) every 3 weeks for up to 1 year (17 cycles)

LN-144 is composed of autologous TIL, which are obtained from an individual participant's tumor and expanded ex vivo through cell culture in the presence of the cytokine IL-2 and muromonab CD3, a monoclonal antibody (mAb) to human CD3 (OKT3). Participants will be given LN-144 on day 0 of the study.

LN-144

60 mg/kg of cyclophosphamide will be given intravenously to participants on days -5 and -4 of the study as a part of the NMA-LD regimen

a total of 78 mg/kg Mesna will be given to participants on days -5 and -4 of the study to prevent hemorrhagic cystitis that can be caused by the cyclophosphamide used in the NMA-LD regimen

25 mg/m2 of fludarabine will be given intravenously to participants on days -5 through -1 of the study as a part of the NMA-LD regimen

IL-2 IV administrations at a dose of 600,000 IU/kg may begin as soon as 3 hours after, but no later than 24 hours after, completion of the LN-144 infusion on Day 0. Additional IL-2 doses will be given approximately every 8 to 12 hours for up to 6 total doses

Interleukin-2 (IL-2)

Up to 17 cycles of Pembrolizumab 200mg every 3 weeks starting at Week 12 will occur for up to 1 year during the post-treatment efficacy follow-up

James Isaacs, MD

The purpose of this study is to evaluate the efficacy of adjuvant adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin-2 (IL-2) after a nonmyeloablative lymphodepletion (NMA-LD) preparative regimen, followed by Pembrolizumab.

Primary:

• To evaluate the efficacy of LN-144 with adjuvant Pembrolizumab in Stage IIIb-d melanoma patients as assessed by 6 and 12-month relapse-free survival (RFS)

Secondary:

* To further evaluate the efficacy of LN-144 with adjuvant Pembrolizumab in Stage IIIb-d melanoma patients using overall survival (OS) and distant metastasis-free survival
* To characterize the safety profile of LN-144 in Stage IIIb-d melanoma patients as measured by the incidence of Grade ≥ 3 treatment emergent adverse events (TEAEs) within 3 months of LN-144 administration
* To identify location of relapse
* Rate of achievable recruitment for duration of planned recruitment period

Efficacy & Safety for LN144 With Pembrolizumab With High Risk Stage IIIb-dResectable Melanoma

A Phase I Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN144) With Adjuvant Pembrolizumab for Treatment of Immunotherapy Naïve Patients With High Risk Stage IIIb-dResectable Melanoma

measured as the rate of RFS (Relapse-Free Survival)

measured by the incidence Serous Adverse Events (SAE)

measured using overall survival (OS). This is the length of time from the start of treatment to a given time point that measures participants on the study that are still alive

measured using Relapse-free survival described as the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer

measured using distant metastasis-free survival (DMFS). This is the length of time from the start of treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.

Incidence of adverse events following LN144 administration

In participants who relapse, the location of the relapse will be located using standard imaging and physical exam

The number of participants enrolled will be counted in which an "achievable" recruitment is considered to be 1 participant every 2-3 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy & Safety for LN144 With Pembrolizumab With High Risk Stage IIIb-dResectable Melanoma	NCT06190249	Stage IIIB Mela... Stage IIIC Mela... Stage IIID Mela...	LN-144 Cyclophosphamid... Mesna Fludarabine Interleukin-2 (... Pembrolizumab	18 Years -	Case Comprehensive Cancer Center
Efficacy & Safety for LN144 With Pembrolizumab With High Risk Stage IIIb-dResectable Melanoma	NCT06190249	Stage IIIB Mela... Stage IIIC Mela... Stage IIID Mela...	LN-144 Cyclophosphamid... Mesna Fludarabine Interleukin-2 (... Pembrolizumab	18 Years -	Case Comprehensive Cancer Center

Spots Global Cancer Trial Database for ln144

Every month we try and update this database with for ln144 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ln144

Every month we try and update this database with for ln144 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ln144 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.