Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group
- Conditions
- Cancermelanoma10040900
- Registration Number
- NL-OMON47131
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
ELIGIBILITY CRITERIA
To be eligbile to participate in this study, patients must be/ have
* At least 18 years of age
* No mucosal or ocular (eye) melanoma, or melanoma with unknown origin of the
primary
* Complete surgical removal (resection) of Stage III melanoma with cutaneous melanoma spread to lymph node,confirmed by microscopy and classified by the American Joint Committee on Cancer (AJCC, 2002) as: Stage IIIA with metastasis greater than 1mm thick; any Stage IIIB or IIIC (no in*transit spread)
* Adequate removal 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).
* General recommendations for surgical and pathological procedures are given in Appendix J of the protocol; a data quality check will be done based on the surgical and pathological reports
* Recommendations for management of the lymph nodes are given in Appendix
J of the protocol and should include the following:
Head and Neck
* Minimum of 15 pathologically investigated nodes
* Face, ear and anterior scalp: parotidectomy plus modified radical neck dissection
* Posterior scalp: modified radical neck dissection plus suboccipital
nodes
Upper Extremity
* Minimum of 10 pathologically investigated nodes
* Axillary node dissection included at least 10 nodes taken from Levels I and II
* Level III nodes dissected if they were clinically involved
* Pectoralis minor muscle was divided or sacrificed
Lower Extremity
* Minimum of 5 pathologically investigated nodes
* Superficial inguinal node dissection was performed for non*palpable nodal involvement
* If Cloquet*s node was positive, a deep inguinal node dissection was
performed Lymph Node Dissection for Nodal Recurrence
* Regional node recurrence was treated using the appropriate lymphadenectomy as above
* Diagnosis of regional node recurrence was made by fine needle aspiration technique to avoid contaminating the region with tumour, followed by Cloquet's Lymph Node Dissection as above
* Full lymphadenectomy must be performed within 12 weeks (84 days) prior to
randomisation
* Disease status for the post*surgery baseline assessment must be documented by full Chest/ Abdomen/ Pelvis CT and/or MRI with Neck CT and/or MRI (for
Head and Neck primary tumours) and complete clinical examination after the
informed consent and prior to randomisation
* The complete set of baseline radiographical images must be available before
randomisation and all images must be of adequate quality
* Disease*free (no loco*regional relapse or distant metastasis); no clinical
evidence for brain metastases
* 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 interferon (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*cancer vaccine therapy can be used for prevention of infectious diseases (up*to) 4 weeks prior and after any dose of ipilimumab or placebo <br
This is mentioned in the Eligibility criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is Recurrence-free survival (RFS). The primary<br /><br>outcome measure of recurrence*free survival will be determined based on the<br /><br>disease recurrence date provided by the IRC (Independent Review Committee).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>. Overall survival (OS)<br /><br>. Distant metastases-free survival (DMFS)<br /><br>. Adverse event profile<br /><br>. Quality of life<br /><br>. Quality-adjusted survival<br /><br><br /><br>The secondary outcome measure of distant metastasis*free survival (DMFS) will<br /><br>be determined based on the 1st date of<br /><br>distant metastasis provided by the Independent Review Committee. The secondary<br /><br>outcome measure of overall survival (OS) is defined as the time from the date<br /><br>of randomisation to the date of death.</p><br>