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A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients With Advanced Melanoma

Phase 2
18 Years
Open (Enrolling)
Recurrent Melanoma, Stage III Melanoma, Stage IV Melanoma

Thank you

Trial Information

A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients With Advanced Melanoma


I. To evaluate the overall survival of patients with advanced melanoma treated with
ipilimumab with versus without sargramostim.


I. To evaluate the progression-free survival of patients treated with these regimens.

II. To evaluate the response rate in patients treated with these regimens. III. To evaluate
the safety and tolerability of these regimens in these patients.

IV. To explore prospectively the utility of immune-related response criteria (irRC) of
patients receiving ipilimumab.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage
(unresectable vs M1a/1b vs M1c) and prior therapy (none vs interferon vs one investigational
therapy). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive induction therapy comprising ipilimumab IV over 90 minutes on day 1
and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21
days for 4 courses. Patients with responsive or stable disease then receive maintenance
therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on
days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim
repeats every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive induction therapy comprising ipilimumab as in arm I. Patients with
responsive or stable disease then receive maintenance therapy comprising ipilimumab IV as in
arm I. Courses repeat every 12 weeks in the absence of disease progression or unacceptable

After completion of study therapy, patients are followed up every 3-6 months for up to 5

Inclusion Criteria:

- Histologically confirmed metastatic melanoma

- Unresectable stage III or IV disease

- For unknown primary disease, diagnosis of metastatic disease by cytology FNA is
not acceptable

- Measurable disease

- No more than 1 prior investigational therapy or systemic therapeutic regimen*,
including any of the following:

- Chemotherapy

- Biological therapy

- Biochemotherapy

- Investigational treatment

- No CNS metastases

- ECOG performance status 0-1

- WBC ≥ 2,000/μL

- ANC ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Hemoglobin ≥ 8 g/dL

- Creatinine ≤ 3.0 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Bilirubin ≤ 3.0 times ULN (total bilirubin < 3.0 mg/dL for patients with Gilbert

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 12 weeks after
completion of study

- No HIV infection

- No active infection with hepatitis B virus

- No active or chronic infection with hepatitis C virus

- No other malignancy with the past 2 years except adequately treated and cured basal
cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ
of the cervix

- No history of autoimmune disease, including any of the following:

- Inflammatory bowel disease

- Symptomatic disease (e.g., rheumatoid arthritis, systemic progressive

- Systemic lupus erythematosus

- Autoimmune vasculitis (e.g., Wegener granulomatosis)

- Motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome
and myasthenia gravis)

- Patients with a history of autoimmune thyroiditis are eligible if their current
thyroid disorder is treated and stable with replacement or other medical therapy

- No underlying medical or psychiatric condition that, in the opinion of the
investigator, will make the administration of study drug hazardous or obscure the
interpretation of adverse events, such as a condition associated with frequent

- No concurrent medical condition requiring the use of systemic steroids

- No other concurrent CTLA-4 inhibitor or agonist or CD137 agonist

- At least 4 weeks since prior and no concurrent therapy with any of the following:

- Aldesleukin (IL-2)

- Interferon

- Non-study immunotherapy regimens

- Cytotoxic chemotherapy

- Immunosuppressive agents

- Other investigational therapies

- Chronic use of systemic corticosteroids

- Concurrent inhaled or topical steroids allowed

- Concurrent physiologic replacement doses of corticosteroids allowed

- No prior non-oncology vaccine therapy for the prevention of infectious disease within
the past 28 days or after any dose of ipilimumab

- No prior ipilimumab, CD137agonist, or CTLA-4 inhibitor or agonist

- No other systemic or local anticancer medications

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

The method of Kaplan- Meir will be used.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Frank Hodi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage III Melanoma
  • Stage IV Melanoma
  • Melanoma



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