Clinical trial · Interventional
Ticilimumab (CP-675,206) in Treating Patients With Stage IIIC or Stage IV Melanoma
A Phase II, Open-Label, Single Arm Clinical Trial to Study the Mechanism of Action of CP-675,206 in Patients With In-Transit and Metastatic Melanoma Amenable to Repeated Outpatient Tumor Biopsies
- 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: Monoclonal antibodies, such as ticilimumab (CP-675,206), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well ticilimumab (CP-675,206) works in treating patients with stage IIIC or stage IV melanoma.
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 |
|---|---|---|---|
| CP-675,206 | Biological | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment-Single Arm
- description
- See intervention descriptions
- interventionNames
- Biological: CP-675,206
Primary outcomes (1)
- measure
- Change in Tumor Infiltration by Cluster of Differentiation 8 (CD8) Positive Cytotoxic T Lymphocytes
- timeFrame
- pre treatment - post treatment at 24 months
- description
- Tumor infiltration of cluster of differentiation 4 and cluster of differentiation 8 (CD4+ and CD8+) cells (intratumoral and peritumoral) was assessed by immunohistochemistry of tumor tissue obtained through biopsy before and after administration of tremelimumab. Up to 10 randomly selected fields per sample were analyzed.
Secondary outcomes (5)
- measure
- Change in Intratumoral Expression of the Proteins HLA-DR, CD45RO, Ki67 and FOXP3 and FOXP3"
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed melanoma that is surgically incurable and either: * Stage IIIc melanoma including locally relapsed, satellite, in-transit lesions or bulky draining lymph node metastasis. * Stage IV melanoma (M1a, M1b, M1c) with accessible lesions for biopsy. * At least 2 lesions amenable for outpatient biopsies * No restriction based on prior treatments * Disease progression after the last dose of prior therapy * A minimum of one measurable lesion defined as: * Meeting the criteria for measurable disease according to Response Evaluation Criteria in Solid Tumors * Skin lesion(s) selected as non-completely biopsied target lesions that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s). * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate bone marrow and hepatic function determined within 30 days prior to enrollment, defined as: * Absolute neutrophil count \> 1.0 x 10\^9 cells/L * Platelets \> 90 x 10\^9 /L * Hemoglobin \> 9 g/L * Aspartate and alanine aminotransferases \< 2.5 x upper limit of normal (ULN) (\< 5 x ULN, if documented liver metastases are present) * Total bilirubin \< 2 x ULN (except patients with documented Gilbert's syndrome) * Must be willing and able to provide writing informed consent. * Must be willing and able to accept at least two tumor biopsies. * Must be willing and able to accept at least two leukapheresis procedures. Exclusion Criteria: * Received treatment for cancer, including immunotherapy, within one month prior to dosing. * Previous participation in Pfizer study A3671009: A Phase 3, Open Label, Randomized Comparative Study of CP-675,206 and Either Dacarbazine or Temozolomide in Patients with Advanced Melanoma * Eligible for enrollment to Pfizer A3671008: A Phase 2, Open Label, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of CP-675,206 in Patients with Advanced Refractory and/or Relapsed Melanoma * History of significant evidence of risk for chronic inflammatory or autoimmune disease. Patents will be eligible if prior autoimmune disease of the hypophysis was treated locally or have resulted in fibrotic damage requiring thyroid hormone replacement. Vitiligo will not be a basis for exclusion. * History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis or any origin * Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 4 weeks prior to enrollment * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol * Clinically active brain metastases. Radiological documentation of absence of brain metastases at screening is required for all patients * Pregnancy or breast-feeding.
References
Publications (3)
- BACKGROUNDvon Euw E, Chodon T, Attar N, Jalil J, Koya RC, Comin-Anduix B, Ribas A. CTLA4 blockade increases Th17 cells in patients with metastatic melanoma. J Transl Med. 2009 May 20;7:35. doi: 10.1186/1479-5876-7-35. PMID 19457253
- DERIVEDHuang RR, Jalil J, Economou JS, Chmielowski B, Koya RC, Mok S, Sazegar H, Seja E, Villanueva A, Gomez-Navarro J, Glaspy JA, Cochran AJ, Ribas A. CTLA4 blockade induces frequent tumor infiltration by activated lymphocytes regardless of clinical responses in humans. Clin Cancer Res. 2011 Jun 15;17(12):4101-9. doi: 10.1158/1078-0432.CCR-11-0407. Epub 2011 May 10. PMID 21558401
- 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