Clinical trial · Interventional
Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
NCT01034787CI-TRIAL-00030107completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a Phase 2, multi-center, open-label study in patients with surgically incurable stage III or IV uveal melanoma who have not received prior immunotherapy. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 has been shown to induce durable tumor responses in patients with metastatic melanoma in phase 1 and phase 2 clinical studies.
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 |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-675,206 | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open Label CP-675,206
- description
- Patients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of every 90-day cycle for up to 4 cycles or until disease progression or intolerance of toxicity.
- interventionNames
- Drug: CP-675,206
Primary outcomes (1)
- measure
- Progression-free survival at 6 months after initiation of CP-675,206
- timeFrame
- 6 months
- description
- A 6-month progression free survivor will be defined as a patient who is alive and who has not progressed at 6 months or more post treatment.
Secondary outcomes (4)
- measure
- Objective tumor response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed uveal melanoma including choroidal melanoma, iris melanoma, and ciliary body melanoma * Patients may either have measurable disease or non-measurable disease. * Biopsies from a readily accessible site of disease on study enrollment are mandatory in principle. Waivers will be granted if there are no accessible lesions. The collection of a representative block of the diagnostic tumour tissue (if available) is mandatory. * ECOG performance status of 0 or 1 * Age 18 years or older * Adequate bone marrow, hepatic, and renal function determined within 14 days prior to registration, defined as: * Serum lactic acid dehydrogenase (LDH) \</= 1.5 x ULN. * Alkaline phosphatase (ALP) \</= 2 x ULN. * No weight loss \>/= 10% in the proceeding 4 weeks. * CT scan of the brain with contrast or MRI of the brain within 28 days of registration showing no evidence of brain metastases. * Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential. * Females of childbearing potential and males who have not undergone surgical sterilization must agree to practice a form of effective contraception prior to entry into the study and for 12 months following the last dose of study drug. The definition of effective contraception will be based on the judgment of the investigator. Exclusion Criteria: * Melanoma of cutaneous, mucosal or conjunctival origin. * History of brain or leptomeningeal metastases. * Received any prior CTLA4 inhibiting agent (eg MDX-010, ipilimumab) or other immunotherapy. * History of chronic inflammatory or autoimmune disease * History of uveitis or melanoma-associated retinopathy. * History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin. * History of hepatitis due to Hepatitis B virus or Hepatitis C virus
References
Publications (2)
- BACKGROUNDRietschel P, Panageas KS, Hanlon C, Patel A, Abramson DH, Chapman PB. Variates of survival in metastatic uveal melanoma. J Clin Oncol. 2005 Nov 1;23(31):8076-80. doi: 10.1200/JCO.2005.02.6534. PMID 16258106
- BACKGROUNDBedikian AY, Legha SS, Mavligit G, Carrasco CH, Khorana S, Plager C, Papadopoulos N, Benjamin RS. Treatment of uveal melanoma metastatic to the liver: a review of the M. D. Anderson Cancer Center experience and prognostic factors. Cancer. 1995 Nov 1;76(9):1665-70. doi: 10.1002/1097-0142(19951101)76:93.0.co;2-j. PMID 8635073