A phase II study to evaluate safety and efficacy of combined treatment with ipilimumab and intratumoral interleukin-2 in pretreated patients with stage IV melanoma - i i i Study

niversity Clinical Center of Tuebingen0 sitesAugust 31, 2011

ConditionsStage IV Melanoma MedDRA version: 14.0Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsYERVOY®PROLEUKIN® S

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stage IV Melanoma
Sponsor: niversity Clinical Center of Tuebingen
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 31, 2011

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Clinical Center of Tuebingen

Eligibility Criteria

Inclusion Criteria

•Willing and able to give written informed consent;
•Histological diagnosis of malignant melanoma;
•Stage IV melanoma;
•At least one injectable lesions \> 5 mm (longest diameter) or at least 5 injectable lesions \< 5 mm.
•Measurable disease. Note: lesions, which are designated for direct IL \-2 injections, must not be considered in the evaluation of measurability;
•Men and women, ? 18 years of age;
•Patient must have demonstrated 1 of the following in response to at least 1 cycle of 1 or more systemic regimens:
•1\) relapse following an objective response (PR/CR);
•2\) failed to demonstrate an objective response (PR/CR); or
•3\) inability to tolerate treatment due to unacceptable toxicity

Exclusion Criteria

•Any other prior malignancy from which the patient has been disease\-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix;
•Ocular melanoma; mucosal melanoma
•Either untreated or symptomatic central nervous system (CNS) metastases (patients with brain metastases who are identified at screening may be rescreened after the lesion(s) have been appropriately treated);
•Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain\-Barre Syndrome). Patients with vitiligo may be included.
•Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
•Any non\-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
•A history of prior systemic treatment with ipilimumab, CD137 agonist, CTLA 4 inhibitor, CTLA\-4 agonist or IL\-2 in stage IV melanoma.
•Concomitant or less than 4 weeks off therapy with any of the following: interferon; other non\-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; chronic use of systemic corticosteroids.
•Women of childbearing potential (WOCBP), defined in Section 5\.3, who:
•1\.are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26 weeks after cessation of study drug, or