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This study is planned to test the safety and tolerability of the TIL regimen. The study will also test how well TIL fights cancer. The study will enroll children, teenagers, and young adults with solid tumors that have returned or are not responding to treatment for whom no effective standard-of-care treatment options exist.
Study details include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhabdomyosarcoma (RMS) | Experimental |
| |
| Ewing Sarcoma (EWS) | Experimental |
| |
| Primary Central Nervous System Tumor | Experimental |
| |
| Melanoma | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LN-145/LN-144 | Biological | A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of Treatment-Emergent Adverse Events | To evaluate the safety and tolerability of the TIL regimen that occurs from the start of TIL infusion and up to 30 days after TIL infusion per CTCAE. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | To evaluate the proportion of participants who have confirmed complete response (CR) or partial response (PR) per RECIST v1.1 or RAPNO. | Up to 24 months |
| Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iovance Biotherapeutics Study Team | Iovance Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Colorado | Aurora | Colorado | 80045 | United States | ||
| Johns Hopkins All Children's Hospital |
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Participants are assigned one of three arms depending on their tumor type.
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To measure the time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1 or RAPNO.
| Up to 24 months |
| Disease Control Rate | To measure by the percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) at any time or stable disease (SD) for at least 4 weeks per RECIST v1.1 or RAPNO. | Up to 24 months |
| Progression-Free Survival | To evaluate the time from the date of the TIL infusion until disease progression per RECIST v1.1 or RAPNO. | Up to 24 months |
| Overall Survival | To measure the time from the date of TIL infusion to death due to any cause. | Up to 24 months |
| St. Petersburg |
| Florida |
| 33701 |
| United States |
| Rutgers Cancer Institute | New Brunswick | New Jersey | 08901 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14203 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D008545 | Melanoma |
| D012208 | Rhabdomyosarcoma |
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
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