Tinostamustine and Nivolumab in Advanced Melanoma
NCT03903458 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2019-04-08
Summary
This trial is a first-in-human drug combination with the first-in-class alkylating histone deacetylase inhibition (HDACi) fusion molecule Tinostamustine (EDO-S101) and the anti-PD-1 monoclonal antibody Nivolumab in patients with refractory, locally advanced or metastatic melanoma.
Conditions
- Malignant Melanoma
Interventions
- DRUG
-
Tinostamustine
First-in-human administration of the combination of Tinostamustine and Nivolumab.
Sponsors & Collaborators
-
Markus Joerger
lead OTHER
Principal Investigators
-
Markus Joerger, Prof. · Cantonal Hospital St. Gallen, Switzerland
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-07
- Primary Completion
- 2021-12-15
- Completion
- 2024-03-15
Countries
- Switzerland
Study Locations
More Related Trials
-
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
NCT03329846 ·Status: COMPLETED ·Phase: PHASE3
-
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
NCT02156804 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
NCT02388906 ·Status: COMPLETED ·Phase: PHASE3
-
PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma
NCT01621490 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1b Study of the Selective HDAC Inhibitor Mocetinostat in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma
NCT03565406 ·Status: TERMINATED ·Phase: PHASE1
-
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
NCT04099251 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma
NCT02581930 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma
NCT03259425 ·Status: TERMINATED ·Phase: PHASE2
-
Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma
NCT04493203 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma
NCT02723006 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.
NCT04835805 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy Among BRAF-Positive Melanoma Patients Treated in the Adjuvant Setting and Among BRAF-Positive Metastatic Melanoma Patients With Low Tumor Burden
NCT05611229 ·Status: COMPLETED
-
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
NCT05655312 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Nivolumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma
NCT03834233 ·Status: UNKNOWN ·Phase: PHASE2
-
Phase I of Histone Deacetylase (HDAC) Inhibitor Panobinostat With Ipilimumab With Unresectable III/IV Melanoma
NCT02032810 ·Status: COMPLETED ·Phase: PHASE1
-
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
NCT03620019 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection
NCT03980314 ·Status: COMPLETED ·Phase: PHASE1
-
Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma
NCT04091750 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma
NCT04674683 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
NCT05297565 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
NCT02967692 ·Status: TERMINATED ·Phase: PHASE3
-
Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma
NCT04375527 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma
NCT05912244 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Neoadjuvant Combination Therapy With Ipilimumab and HighDose IFN-α2b for Melanoma
NCT01608594 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Combination of Ipilimumab and Nivolumab in Patients With Melanoma
NCT02970981 ·Status: COMPLETED ·Phase: PHASE2