NCT03638375: ACTME

TIL and Anti-PD1 in Metastatic Melanoma

Status unknown Phase 1, PHASE2 Last updated 12 December 2023

What this trial tests

Phase 1, PHASE2 trial testing Nivolumab & Tumor Infiltrating Lymphocytes with/without Interferon-Alpha in Toxicity, Drug in 34 participants. Status unknown.

Timeline

31 July 2018

Primary endpoint
29 November 2025

29 November 2025

Quick facts

Lead sponsor	Leiden University
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	31 July 2018
Primary completion	29 November 2025
Estimated completion	29 November 2025
Sites	1 location across Netherlands

Drugs / interventions tested

• Nivolumab & Tumor Infiltrating Lymphocytes with/without Interferon-Alpha — full drug profile →

Conditions studied

• Toxicity, Drug — all drugs for Toxicity, Drug →
• Adverse Drug Event — all drugs for Adverse Drug Event →
• Effects of Immunotherapy — all drugs for Effects of Immunotherapy →

Sponsor

Leiden University

Who can join

18 and older, any sex, with Toxicity, Drug or Adverse Drug Event. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The ACTME study is an investigator initiated, single center phase I/II clinical trial for patients with progressive unresectable stage III or stage IV melanoma. The trial consists of both a phase I part to determine safety and feasibility and a phase II part to evaluate first clinical activity of IFN-alpha, nivolumab and TIL. The treatment with IFN-alpha will be added after the combination of TIL and nivolumab has proven to be safe.

Publications & conference data

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

1. Adoptive cell therapy in combination with checkpoint inhibitors in ovarian cancer.
   Kverneland AH, Pedersen M, Westergaard MCW, Nielsen M, et al · · 2020 · cited 84× · PMID 32547707 · DOI 10.18632/oncotarget.27604
2. 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
3. The Current State of Treatment and Future Directions in Cutaneous Malignant Melanoma.
   Ernst M, Giubellino A. · · 2022 · cited 49× · PMID 35453572 · DOI 10.3390/biomedicines10040822
4. Adoptive tumor infiltrating lymphocytes cell therapy for cervical cancer.
   Zhu Y, Zhou J, Zhu L, Hu W, et al · · 2022 · cited 21× · PMID 35468048 · DOI 10.1080/21645515.2022.2060019
5. 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
6. Low-dose interferon-alpha preconditioning and adoptive cell therapy in patients with metastatic melanoma refractory to standard (immune) therapies: a phase I/II study.
   Verdegaal E, van der Kooij MK, Visser M, van der Minne C, et al · · 2020 · cited 19× · PMID 32238469 · DOI 10.1136/jitc-2019-000166
7. Emerging Approaches for Solid Tumor Treatment Using CAR-T Cell Therapy.
   Chung H, Jung H, Noh JY. · · 2021 · cited 18× · PMID 34830003 · DOI 10.3390/ijms222212126
8. NF-κB Signaling in Targeting Tumor Cells by Oncolytic Viruses-Therapeutic Perspectives.
   Struzik J, Szulc-Dąbrowska L. · · 2018 · cited 18× · PMID 30413032 · DOI 10.3390/cancers10110426