TIL and Anti-PD1 in Metastatic Melanoma

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

July 31, 2018

Primary Completion Date

November 29, 2025

Study Completion Date

November 29, 2025

Conditions
Toxicity, DrugAdverse Drug EventEffects of Immunotherapy
Interventions
DRUG

Nivolumab & Tumor Infiltrating Lymphocytes with/without Interferon-Alpha

"During 15 weeks patients will be treated with nivolumab (3mg/kg i.v.) once every two weeks. Four weeks after starting nivolumab, patients will receive their first TIL infusion (2.5-7.5x10\^8 T cells i.v.) once every three weeks for three infusions.~In the second group treatment with IFN-alpha (3 million IU s.c.) daily will be added one week before the first TIL infusion and will be continued for 11 weeks."

Trial Locations (1)

2333 ZA

Leiden University Medical Center, Leiden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Leiden University

OTHER