Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, doubleblind Phase 3 trial of the EORTC Melanoma Group Inmunoterapia adyuvante con ipilimumab, un anticuerpo monoclonal anti-CTLA-4, frente a placebo tras la resección completa del melanoma en estadio III de alto riesgo: Ensayo de fase 3, aleatorizado y en doble ciego, del Grupo de Melanoma de la EORTC - EORTC protocol 18071

Overview

No summary available.

Registry

who.int

Start Date

January 21, 2009

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\) Signed Written Informed Consent
•\- Written informed consent required prior to clinical trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the trial registration, according to ICH/EU GCP, and national/local regulations
•2\) Target Population
•\- No mucosal or ocular melanoma, or melanoma with unknown origin of the primary
•\- Complete resection of Stage III melanoma (AJCC R0\) with histologically confirmed cutaneous melanoma metastatic to lymph node, classified as (AJCC, 2002\): Stage IIIA with metastasis \> 1mm; any Stage IIIB or IIIC (no in\-transit metastases)
•\- Adequate resection of Stage III lymph nodes per Criteria for adequate surgical procedures for complete lymph node dissection (CLND) as documented on the operating report and pathology report. Patients without documentation of adequate resection are not eligible
•\- Recommendations for management of the lymph nodes are given in Appendix J and should include the following:
•a) Head and Neck
•\- Minimum of 15 pathologically investigated nodes
•\- Face, ear, and anterior scalp: parotidectomy plus modified radical neck dissection

•1\) Sex and Reproductive Status
•\- WOCBP unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last administration of the perfusion, women who are pregnant or breastfeeding, women with a positive pregnancy test on enrollment or prior to study drug administration, and sexually active fertile men whose partners are WOCBP, unless using an adequate method of birth control
•2\) Medical History and Concurrent Diseases
•\- No radiation therapy to the lymph node dissection field after surgery
•\- No prior therapy for melanoma except surgery for primary melanoma lesions; patients who have previously received IFN are not eligible
•\- No prior or concomitant therapy with any anti\-cancer agents, immunosuppressive agents; other investigational anti\-cancer therapies, or chronic use of systemic corticosteroids (used in the management of cancer or non\-cancer\-related illnesses)
•\- No non\-oncology vaccine therapy can be used for prevention of infectious diseases (up\-to) 4 weeks prior and after any dose of ipilimumab or placebo
•\- No prior treatment with a CD137 agonist or CTLA\-4 inhibitor or agonist
•\- No previous participation in another ipilimumab (MDX\-010\) clinical trial
•\- No treatment with other investigational products within the last 4 weeks prior to randomization into this study