NCT04165967: BaseTIL

Adoptive Tumor-infiltrating Lymphocyte Transfer With Nivolumab for Melanoma

Completed Phase 1 Last updated 10 April 2024

What this trial tests

Phase 1 trial testing Combination of TIL Transfer with anti-PD-1 Therapy and low dose IL-2 in Advanced Melanoma in 9 participants. Completed in 30 March 2023.

Timeline

17 September 2020

Primary endpoint
30 March 2023

30 March 2023

Quick facts

Lead sponsor	University Hospital, Basel, Switzerland
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	17 September 2020
Primary completion	30 March 2023
Estimated completion	30 March 2023
Sites	1 location across Switzerland

Drugs / interventions tested

• Combination of TIL Transfer with anti-PD-1 Therapy and low dose IL-2 — full drug profile →

Conditions studied

• Advanced Melanoma — all drugs for Advanced Melanoma →

Sponsor

University Hospital, Basel, Switzerland

Who can join

Adults 18 to 75, any sex, with Advanced Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to investigate safety and feasibility of a combination therapy of a tumor infiltrating lymphocytes (TIL) transfer with anti-programmed cell death protein (PD)-1 therapy in patients with metastatic melanoma that failed immunotherapy.Tumor-infiltrating lymphocytes will be expanded from resected melanoma samples from the patient and expanded TILs will be transferred to the patient after non-myeloablative chemotherapy with cyclophosphamide and fludarabine. TIL transfer will be combined with low dose Interleukin (IL)-2 and nivolumab anti-PD-1 treatment.

The study uses a personalized Investigational Medicinal Product (IMP), i.e. TIL product and in combination with IL-2 treatment and nivolumab.

Publications & conference data

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

1. Skin cancer: understanding the journey of transformation from conventional to advanced treatment approaches.
   Hasan N, Nadaf A, Imran M, Jiba U, et al · · 2023 · cited 117× · PMID 37803407 · DOI 10.1186/s12943-023-01854-3
2. Tumor Infiltrating Lymphocyte (TIL) Therapy for Solid Tumor Treatment: Progressions and Challenges.
   Zhao Y, Deng J, Rao S, Guo S, et al · · 2022 · cited 114× · PMID 36077696 · DOI 10.3390/cancers14174160
3. Tumor-Infiltrating Lymphocyte Therapy in Melanoma: Facts to the Future.
   Betof Warner A, Corrie PG, Hamid O. · · 2023 · cited 81× · PMID 36485001 · DOI 10.1158/1078-0432.ccr-22-1922
4. Emerging Novel Therapeutic Approaches for Treatment of Advanced Cutaneous Melanoma.
   Comito F, Pagani R, Grilli G, Sperandi F, et al · · 2022 · cited 20× · PMID 35053435 · DOI 10.3390/cancers14020271
5. Therapeutic approaches to enhance natural killer cell cytotoxicity.
   Stenger TD, Miller JS. · · 2024 · cited 14× · PMID 38545115 · DOI 10.3389/fimmu.2024.1356666
6. Adoptive cell therapy with tumor-infiltrating lymphocytes in combination with nivolumab in patients with advanced melanoma.
   König D, Kasenda B, Sandholzer M, Chirindel A, et al · · 2024 · cited 5× · PMID 39801681 · DOI 10.1016/j.iotech.2024.100728
7. Precision Nuclear Medicine: The Evolving Role of PET in Melanoma.
   Wright CL, Miller ED, Contreras C, Knopp MV. · · 2021 · cited 5× · PMID 34392917 · DOI 10.1016/j.rcl.2021.05.007
8. Advances in Tumor-Infiltrating Lymphocyte (TIL) as a Prognostic Factor and for Treating Invasive Cutaneous Melanoma.
   de Oliveira GAF, de Oliveira DA, Nisimoto MYSM, Rubinho R, et al · · 2024 · cited 2× · PMID 39684307 · DOI 10.3390/ijms252312596