Advanced Melanoma Clinical Trial
Official title:
A Phase I Trial of Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes and ANV419 in Patients With Advanced Melanoma. The BaseTIL-03M Trial
In this study we aim to investigate safety and tolerability of tumor-infiltrating lymphocytes (TIL) adoptive cell therapy (ACT) incorporation in-vivo TIL expansion with ANV419 in patients with advanced melanoma
In brief, this trial consists of four study periods: screening, pre-treatment, treatment, and observational follow-up. In the screening period, patients are screened for trial eligibility. In the pre-treatment period, patients have excisional biopsy/surgical resection of tumor lesion(s) (tumor collection) and TILs are expanded from this lesion/these lesions (TIL expansion). Patients are permitted to receive bridging therapy outside of the study protocol. In the treatment period, patients have TIL-ACT. TIL-ACT includes a detailed procedure of preparative chemotherapy, followed by transfer of the TIL product, followed by in-vivo TIL expansion with ANV419 (2 doses). TIL transfer is defined as day 0 in the study protocol. Patients have an End of Treatment visit (14 days after the last study treatment), a safety follow-up (30 days after the last study treatment) and an efficacy follow up, which is the End of Study visit (day +90). Thereafter, patients will transfer to observational follow-up, which is conducted every 3 months until 1 year after TIL transfer. Patients who terminate the study prematurely during any of the treatment period due to e.g., disease progression, toxicity, patient wish, etc. will also transfer to observational follow-up. The regimen (TIL-ACT with ANV419) has not been tested. Review by the IDSMB (independent data safety monitoring board) will be performed after 3 patients (safety check). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05039801 -
IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT04894994 -
FLX475 in Combination With Ipilimumab in Advanced Melanoma
|
Phase 2 | |
| Completed |
NCT01621490 -
PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma
|
Phase 1 | |
| Recruiting |
NCT05098184 -
Study on TIL for the Treatment of Advanced Melanoma
|
Early Phase 1 | |
| Completed |
NCT02177110 -
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
|
||
| Completed |
NCT00197912 -
Dendritic Cell Based Therapy of Malignant Melanoma
|
Phase 1/Phase 2 | |
| Completed |
NCT04165967 -
Adoptive Tumor-infiltrating Lymphocyte Transfer With Nivolumab for Melanoma
|
Phase 1 | |
| Active, not recruiting |
NCT04495257 -
A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC)
|
Phase 1 | |
| Recruiting |
NCT05968690 -
Naltrexone and Propranolol Combined With Immunotherapy
|
Phase 1 | |
| Active, not recruiting |
NCT03200847 -
Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05105100 -
Peripheral T Cell Determinants of Response and Resistance to Pembrolizumab in Melanoma
|
||
| Completed |
NCT02171286 -
The Oncopanel Pilot (TOP) Study
|
N/A | |
| Terminated |
NCT01453361 -
Phase II FANG™ in Advanced Melanoma
|
Phase 2 | |
| Recruiting |
NCT05120024 -
Multicenter Study of Safety and Efficacy of Prolgolimab in Patients With Advanced Melanoma in Routine Clinical Practice
|
||
| Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
| Active, not recruiting |
NCT04951583 -
Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma
|
Phase 2 | |
| Recruiting |
NCT06112808 -
A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
|
Phase 1 | |
| Recruiting |
NCT01614301 -
Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04640545 -
A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma
|
Phase 1 | |
| Active, not recruiting |
NCT03086174 -
Tolerability and Pharmacokinetics of Toripalimab in Combination With Axitinib in Patients With Kidney Cancer and Melanoma
|
Phase 1 |