Trial Information

ECOG E1609 Phase III Randomized Study of Adjuvant Ipilimumab Versus High-Dose Recombinant Interferon Alfa-2b in Patients With High-Risk Stage IIIB, IIIC, or IV Melanoma

The purpose of this study is to compare the effects, good and/or bad, of ipilimumab (given at 2 different doses, 10 mg/kg or 3 mg/kg) with interferon alfa-2b on you and your melanoma to find out which is better. In this study, you will get ipilimumab (either at 10 mg/kg or 3 mg/kg) or the interferon alfa-2b. You will not get both. We plan to determine whether ipilimumab stops or delays your cancer from returning in comparison to interferon alfa-2b.

High doses of interferon alfa-2b can reduce the risk of melanoma returning, but only some patients benefit from interferon. This interferon is commercially available. We hope to find a more effective and long-lasting treatment for your type of cancer. Ipilimumab is a biological agent that has been shown to have anti-tumor activity in advanced melanoma. Interferon alfa-2b is FDA-approved as an adjuvant treatment to surgery in adult patients with melanoma who are free of disease but at high risk for recurrence. Ipilimumab is investigational and has not been approved by the FDA for use in this stage of melanoma. However, it is approved at a dose of 3 mg/kg for more advanced metastatic melanoma that is not amenable to surgical resection.

We also want to know your view of how your life has been affected by cancer and its treatment. For this "Quality of life" (QOL) study, you will be given short questionnaires at different times during the trial. The QOL study looks at how you are feeling physically and emotionally during your cancer treatment and at how you are able to carry out your day-to-day activities. If any questions make you feel uncomfortable, you may skip those questions and not give an answer. This information will help doctors better understand how patients feel during treatments and what effects the medicines are having.

Patient Inclusion Criteria:

No other visceral metastases allowed
Patients with unknown primary melanoma (Tx) who present with cutaneous, subcutaneous, nodal, and/or lung metastases that are completely surgically resected with free margins are allowed
Disease that has been completely resected with negative margins on resected specimens within the past 12 weeks
Disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization
Imaging studies must include a total body PET-CT scan (with or without brain) and brain MRI or CT (if MRI is contraindicated) (if PET-CT cannot be done, CT scan of neck, chest, abdomen, and pelvis should be done)

Patient Exclusion Criteria:

Patients rendered free of disease by non-surgical means not allowed
Patients with clinically positive lymph nodes for melanoma involvement or those with positive lymph nodes identified through lymphoscintigraphic and/or dye lymphographic techniques in the groin, axilla, or neck should have additional lymphadenectomy in those sites
The complete lymph node dissection procedure would be considered as the last surgery in counting the 84 days unless a subsequent surgical procedure(s) was clinically required to ensure the disease-free status
Patients with disease recurrence after adequate surgical excision of the original primary cutaneous/unknown primary melanoma are allowed even if they don’t fit the strict staging criteria, but only as follows:
1. Recurrence in a regional lymph node basin after a prior complete lymph node dissection
2. Relapsed disease must be completely surgically resected with free margins
3. Recurrence in the form of in-transit or satellite metastases or distant skin/subcutaneous, nodal, or lung metastases that are completely surgically resected with free margins
4. Recurrence in a regional lymph node basin
5. Relapsed disease must be completely surgically resected with free margins

No prior adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after resection
At least 21 days since prior radiotherapy, including after surgical resection
No prior or concurrent anti-CTLA4 monoclonal antibodies, CTLA-4 inhibitor or agonist, CD137 agonist, or prior interferon-a
At least 4 weeks since prior aldesleukin (IL-2), anti-tumor vaccine, or chemotherapy given before randomization
No infectious disease vaccination (e.g., standard influenza, H1N1 influenza, pneumococcal, meningococcal, or tetanus toxoid) within the past 4 weeks
No concurrent systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone), continuous use of topical steroid creams or ointments, or ophthalmologic steroids
Occasional but not continuous use of steroid inhalers allowed
Systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone), continuous use of topical steroid creams or ointments, or ophthalmologic steroids within the past 2 weeks allowed provided, in judgment of the treating physician investigator, that the patient is not likely to require resumption of treatment with these classes of drugs during the study
Replacement doses of steroids for patients with adrenal insufficiency allowed
No concurrent chemotherapy or radiotherapy
No other concurrent anticancer or investigational agent
ECOG performance status 0-1
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use adequate method of contraception throughout the study and for 26 weeks after the last dose of high-dose recombinant interferon alfa-2b (HDI)
No active infection requiring concurrent treatment with parenteral antibiotics
None of the following:
1. Other significant medical, surgical, or psychiatric conditions
2. Requirement for any medication or treatment that, in the opinion of the investigator, may interfere with compliance, make the administration of high-dose ipilimumab, low-dose ipilimumab, or HDI hazardous, or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
3. No documented history of inflammatory bowel disease, including ulcerative colitis and Crohn disease, or diverticulitis
4. History of diverticulosis allowed
5. No autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids or continuous use of topical steroid creams or ointments or ophthalmologic steroids
6. History of occasional (but not continuous) use of steroid inhalers allowed

None of the following:
1. History of symptomatic autoimmune disease
2. Rheumatoid arthritis
3. Systemic progressive sclerosis (scleroderma)
4. Systemic lupus erythematosus
5. Sjögren syndrome
6. Autoimmune vasculitis (e.g., Wegener granulomatosis)
7. Motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis)
8. Other CNS autoimmune disease (e.g., poliomyelitis, multiple sclerosis)
9. Autoimmune hypothyroid disease or type 1 diabetes allowed provided replacement therapy is administered

Not incarcerated or compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
No other current malignancies except any prior in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary melanomas, basal or squamous skin cancer, or other malignancies for which the patient has been disease free for > 5 years
No active or chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
Patients must have negative serology/testing for HIV, HBV, and HCV within the past 4 weeks

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071
Email: janeen.bazan@shermanhospital.org

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Research Center Information: Sherman Health

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