Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Vaccines

Ipilimumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients will receive 5 administrations of autologous TriMix-DC, administrations 2, 3, 4 and 5 will be preceded by ipilimumab (a CTLA-4 blocking monoclonal antibody, at a dose of 10 mg/kg). Patients who are free from progression according to the irRC will be offered ipilimumab maintenance administrations of ipilimumab (10mg/kg q12wks).

TriMix-DC and ipilimumab

The CTLA-4 blocking monoclonal antibody ipilimumab (MDX-010, BMS-734016), has demonstrated anti-tumor activity in a subgroup of patients with Stage III (unresectable) or Stage IV melanoma (measurable per modified WHO criteria), who have received prior treatment with any regimen (non-experimental or experimental), except a CD-137 agonist or a CTLA4 inhibitor or agonist and relapsed, failed to respond (CR or PR) or did not tolerate that regimen (Wolchok, Neyns et al. 2009; O'Day, Maio et al. 2010). Ipilimumab exerts its therapeutic effect presumably by activating T-lymphocytes that infiltrate the tumor mass to destroy the malignant cells by mechanisms of cytotoxic cellular interaction. Autologous TriMix-DC vaccine can induce a T-cell repertoire that recognizes in a HLA-restricted way the melanoma associated antigens MAGE-A3, MAGE-C2, tyrosinase and gp100. Administration of ipilimumab together with TriMix-DC vaccine therapy may be a more effective treatment for patients with advanced melanoma as compared to either modality alone.

Autologous TriMix-DC Therapeutic Vaccine in Combination With Ipilimumab in Patients With Previously Treated Unresectable Stage III or IV Melanoma

A Two-stage Phase II Study of Autologous TriMix-DC Therapeutic Vaccine in Combination With Ipilimumab in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Vrije Universiteit Brussel

Bart Neyns

MD PhD

Pharmaceutical Solutions

Atezolizumab

BMS-936559

Immunologic Factors

Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response

BMS-936559 (Anti-PD-L1)

Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response

Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response

Bristol-Myers Squibb

The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.

Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma

A Phase I Study of the Biologic Effects of BMS-936559 Treatment in Subjects With Unresectable Stage III or IV Melanoma

Dabrafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

ipilimumab and dabrafenib

Phase I/II study of ipilimumab concurrent ipilimumab and dabrafenib as first line treatment in Stage III or IV melanoma.

Assessing safety of Ipilimumab and dabrafenib in combination. Also, assessing disease control rates.

Ipilimumab and Dabrafenib in the 1st Line Tx of Unresectable Stage III/IV Melanoma

A Phase I/II Study of Concurrent Ipilimumab and Dabrafenib in Unresectable Stage III or Stage IV Melanoma

All patients who receive any study treatment will be included in the final summaries and listings of safety data. Detailed information collected for each AE will include a description of the event, duration, severity, relatedness to study drugs, action taken, and clinical outcome. Severity of the AEs will be graded according to the CTCAE version 4.0.

University of Utah

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Autologous TriMix-DC Therapeutic Vaccine in Combination With Ipilimumab in Patients With Previously Treated Unresectable Stage III or IV Melanoma	NCT01302496	Malignant Melan... Malignant Melan...	TriMix-DC and i...	18 Years -	Universitair Ziekenhuis Brussel
Autologous TriMix-DC Therapeutic Vaccine in Combination With Ipilimumab in Patients With Previously Treated Unresectable Stage III or IV Melanoma	NCT01302496	Malignant Melan... Malignant Melan...	TriMix-DC and i...	18 Years -	Universitair Ziekenhuis Brussel
Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma	NCT01455103	Stage III or IV...	BMS-936559 (Ant... BMS-936559 (Ant... BMS-936559 (Ant...	18 Years -	Bristol-Myers Squibb
Ipilimumab and Dabrafenib in the 1st Line Tx of Unresectable Stage III/IV Melanoma	NCT02200562	Stage III or IV...	ipilimumab and ...	18 Years -	University of Utah

Spots Global Cancer Trial Database for stage iii or iv melanoma