Clinical trial · Interventional
CP-675,206 (CTLA4-Blocking Monoclonal Antibody) Combined With Dendritic Cell Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery
A Phase I, Open Label, Study To Evaluate The Safety And Immune Function Effects Of CP-675,206 In Combination With MART-1 Peptide-Pulsed Dendritic Cells In Patients With Advanced Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Biological therapies, such as CP-675,206, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines may make the body build an immune response to kill tumor cells. Combining CP-675,206 with vaccine therapy may cause a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of CP-675,206 when given with vaccine therapy in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CTLA4-Blocking Monoclonal Antibody
- interventionNames
- Biological: maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
Primary outcomes (1)
- measure
- Maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed cutaneous or mucosal melanoma, meeting criteria for 1 of the following: * Unresectable stage III disease (locally relapsed unresectable, in-transit lesions, or unresectable draining nodes) * Stage IV disease, metastatic to 1 of the following sites: * Skin, subcutaneous tissues, or distant lymph nodes * Lung * Other visceral sites with lactic dehydrogenase ≤ 2 times upper limit of normal (unless due to liver stasis) * De novo metastatic disease allowed provided patient refused any standard or approved stage-appropriate therapy for melanoma * Measurable disease * HLA-A2.1 positive (HLA-A\*0201 by molecular subtyping) * MART-1-expressing tumor by reverse transcription polymerase chain reaction or immunohistochemistry * No symptomatic brain metastases and/or progression of CNS metastases within the past 4 weeks * Age 18 and over * Performance status ECOG 0-1 OR * Karnofsky 70-100% * HIV negative * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after study participation * More than 30 days since prior immunotherapy for metastatic, relapsed, or primary melanoma * More than 30 days since prior chemotherapy for metastatic, relapsed, or primary melanoma * More than 4 weeks since prior corticosteroids * More than 30 days since prior radiotherapy for metastatic, relapsed, or primary melanoma * More than 30 days since prior surgery for metastatic, relapsed, or primary melanoma. * More than 30 days since other prior therapy for metastatic, relapsed, or primary melanoma * More than 14 days since prior anti-infective therapy * More than 4 weeks since prior immune suppressive therapy (e.g., cyclosporine) Exclusion Criteria: * chronic hepatitis B or C * asthma * inflammatory bowel disease * celiac disease * history of chronic colitis or other chronic gastrointestinal conditions associated with diarrhea or bleeding * active chronic inflammatory or autoimmune disease, including any of the following: * Psoriasis * Rheumatoid arthritis * Multiple sclerosis * Hashimoto's thyroiditis * Addison's disease * Graves' disease * Systemic lupus erythematosus * active infection OR fever over 100° F within the past 3 days * allergy to study drugs * pregnant * symptomatic seizures * other medical problem that would preclude study participation * prior melanoma immunotherapy containing MART-1 antigen * prior anti-T-cell therapy * prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (CP-675,206) * organ allografts requiring long-term immune suppressive therapy
References
Publications (1)
- DERIVEDComin-Anduix B, Sazegar H, Chodon T, Matsunaga D, Jalil J, von Euw E, Escuin-Ordinas H, Balderas R, Chmielowski B, Gomez-Navarro J, Koya RC, Ribas A. Modulation of cell signaling networks after CTLA4 blockade in patients with metastatic melanoma. PLoS One. 2010 Sep 15;5(9):e12711. doi: 10.1371/journal.pone.0012711. PMID 20856802