Ipilimumab With Carboplatin and Paclitaxel in Patients With Unresectable Stage III and Stage IV Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wilson Miller, Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01676649
First received: August 29, 2012
Last updated: February 14, 2014
Last verified: February 2014

August 29, 2012
February 14, 2014
November 2012
September 2014   (final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01676649 on ClinicalTrials.gov Archive Site
  • Putative Early Cellular and/or Molecular Biomarker levels [ Time Frame: 27 months ] [ Designated as safety issue: No ]
  • To determine ORR and clinical benefit rate (ORR + SD ≥ 24 weeks), by immune related response criteria (irRC) and modified WHO criteria (mWHO) of ipilimumab when given with carboplatin and paclitaxel at two different dosing regimens. [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • To determine the overall survival (OS) of patients receiving ipilimumab with carboplatin and paclitaxel. [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • To determine progression free survival (PFS) per irRC and mWHO of patients receiving ipilimumab with carboplatin and paclitaxel. [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ipilimumab With Carboplatin and Paclitaxel in Patients With Unresectable Stage III and Stage IV Melanoma
A Phase II Study of Ipilimumab in Combination With Carboplatin and Paclitaxel in Patients With Unresectable Stage III or Stage IV Melanoma

The safety of the combination of ipilimumab with carboplatin/paclitaxel treatment with two different dosing schedules will be investigated in patients with metastatic melanoma. This protocol will also investigate both the clinical benefit of this combination and the features of the host immune system that may predict response to ipilimumab with chemotherapy in patients with unresectable Stage III and Stage IV melanoma.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Untreated Stage III Melanoma or Stage IV Melanoma
  • Biological: Ipilimumab
    3 mg/kg
    Other Name: YERVOY
  • Drug: Carboplatin
    AUC = 6
  • Drug: Paclitaxel
    175 mg/m2
  • Experimental: A
    Arm A: Carboplatin (week 1, week 4, week 7, week 10, and week 13) Paclitaxel (week 1, week 4, week 7, week 10, and week 13) Ipilimumab (week 4, week 7, week 10, and week 13)
    Interventions:
    • Biological: Ipilimumab
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: B
    Carboplatin (week 1, week 4, week 7, week 10, and week 13) Paclitaxel (week 1, week 4, week 7, week 10, and week 13) Ipilimumab (week 5, week 8, week 11, and week 14)
    Interventions:
    • Biological: Ipilimumab
    • Drug: Carboplatin
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing and able to give written informed consent.
  • Histologic diagnosis of malignant melanoma
  • Untreated unresectable Stage III melanoma with N3 macroscopic lymph nodes or in-transit/satellite metastases or Stage IV melanoma (note that prior adjuvant melanoma therapy is permitted). Prior treatment with BRAF inhibitors in the metastatic setting is also permitted.
  • Measurable/evaluable disease
  • Required values for initial laboratory tests:

    • WBC ≥ 2000/uL
    • ANC ≥ 1.5 x 10E9/L
    • Platelets ≥ 100 x 10E9/L
    • Hemoglobin ≥ 90 g/L (may be transfused)
    • Creatinine Clearance ≥ 50 ml/min (calculated -Cockcroft-Gault)
    • AST/ALT ≤ 2.5 x ULN for patients without liver metastasis,

      ≤ 5 times for liver metastases

    • Bilirubin ≤ 2.5 x ULN
  • No active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
  • ECOG Performance status of 0 or 1.
  • Men and women, ≥ 18 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.

WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal. Post-menopause is defined as:

  • Amenorrhea ≥ 12 consecutive months without another cause, or
  • For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level ≥ 35 U/L. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab.

Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study [and for up to 26 weeks after the last doseof investigational product] in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

  • Evidence of symptomatic CNS lesions as determined by the investigator (patients with asymptomatic lesions or previously irradiated or surgically resected are eligible).
  • Any other malignancy from which the patient has been disease-free for less than one year, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix.
  • Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).
  • 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.
  • Patients with ≥ Grade 2 peripheral neuropathy.
  • 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 treatment with ipilimumab or prior CD137 agonist or CTLA 4 inhibitor or agonist.
  • Concomitant therapy with any of the following: IL 2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids.
  • Women of childbearing potential (WOCBP), defined above, 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
    2. have a positive pregnancy test at baseline, or
    3. are pregnant or breastfeeding.
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01676649
CA184-195
No
Wilson Miller, Jewish General Hospital
Jewish General Hospital
Not Provided
Principal Investigator: Wilson Miller, MD, PhD Jewish General Hospital
Principal Investigator: Rahima Jamal, MD Notre-Dame Hospital (CHUM)
Jewish General Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP