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A Phase Ib Study of Yervoy With Sylatron for Patients With Unresectable Stages IIIB/C/IV Melanoma

Phase 1
16 Years
Open (Enrolling)

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Trial Information

A Phase Ib Study of Yervoy With Sylatron for Patients With Unresectable Stages IIIB/C/IV Melanoma

Inclusion Criteria:

- Must have cytologically or histologically-confirmed and unresectable melanoma,
previously untreated systemically other than a BRAF inhibitor for metastatic disease,
meeting one of the following American Joint Committee on Cancer (AJCC) staging
criteria: AJCC Stage IV (Tany,Nany,M1); AJCC Stage IIIB/C patients with unresectable
nodal/locoregional involvement; Patients with cutaneous, ocular or mucosal melanoma
are eligible

- Must have adequate hepatic, renal and bone marrow function as defined by the
following parameters obtained within 4 weeks prior to initiation of study treatment.
Hematologic Criteria: white blood count (WBC) >/= 3.0 x 10^9/L, Platelet > 100 x
10^9/L, Hemoglobin >/= 9 g/dL or 5.6 mmol/L; Renal and Hepatic Functional Criteria:
Serum creatinine < 2.0 mg/dL or < 140 ╬╝mol/L, serum glutamic oxaloacetic transaminase
(SGOT) and serum glutamic pyruvic transaminase (SGPT) < 2 times upper normal limit of
laboratory normal (ULN)

- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Must give informed consent according to institutional policy

- Must be willing to give written informed consent and must be able to adhere to dose
and visit schedules

- Female patients of childbearing potential must be using a medically accepted method
of birth control prior to Screening and agree to continue its use during the study or
be surgically sterilized (eg, hysterectomy or tubal ligation). Females of
childbearing potential should be counseled in the appropriate use of birth control
while in this study. Females who are not currently sexually active must agree and
consent to use one of the above-mentioned methods should they become sexually active
while participating in the study.

- Female patients of childbearing potential must have a negative serum pregnancy test
(beta-hCG) at Screening.

Exclusion Criteria:

- Female patients who are pregnant, intend to become pregnant, or are nursing

- Previously treated with interferon alpha 2b, Sylatron or Yervoy therapy for melanoma

- Patients whose disease can be completely surgically resected

- Have not recovered from the effects of recent surgery

- Patients with a history of prior malignancy within the past 2 years other than
surgically cured squamous or basal cell carcinoma of the skin, or cervical carcinoma
in situ

- Have severe cardiovascular disease, ie. arrhythmias requiring chronic treatment,
congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease

- Patients with thyroid dysfunction not responsive to therapy

- Patients who, in the opinion of the investigator, have uncontrolled diabetes mellitus

- Suffering from an active autoimmune disease except medically controlled
hypothyroidism and vitiligo

- An active and/or uncontrolled infection, including active hepatitis

- Have a history of seropositivity for HIV

- Pre-existing psychiatric condition, including but not limited to: History of severe
depression (including Hospitalization for depression, Electroconvulsive therapy for
depression, Depression that resulted in a prolonged absence from work and/or
significant disruption of daily functions); Suicidal of homicidal ideation and/or
suicidal or homicidal attempt; History of severe psychiatric disorders (eg,
psychosis, post-traumatic stress disorder or mania); Past history or current use of
lithium and/or antipsychotic drugs

- A clinical diagnosis of substance abuse of the one or more of the following drugs,
within the following timeframes, (not including time spent in detoxification,
hospitalization or incarceration): Alcohol, intravenous drug use (IVDU),
inhalational, psychotropics, narcotics, cocaine, prescription or over-the-counter
drugs: within 1 year of the Screening visit; Receiving methadone, buprenorphine
hydrochloride (HCL), and/or butorphanol tartrate within 1 year of Screening visit,
unless participant has drug screen negative for other (non-narcotic) drugs documented
in past year and repeated negative within 2 months of Screening visit; Multi-drug
abuse (2 or more substances in 17a and 17b) within 3 years of Screening visit; If the
patient's historic marijuana use is deemed excessive by the principal investigator
(PI), or medically qualified individual or is interfering with the patient's life,
then the patient is not eligible and should not be screened. If patient's marijuana
use is not deemed excessive by PI and does not interfere with life, the patient must
be instructed to discontinue any current use of recreational marijuana prior to entry
into study.

- Patients with a medical condition requiring chronic systemic corticosteroids

- Known to be allergic to the drug substance or any of the excipients in the Sylatron
or Yervoy formulation

- Patients who are in a situation or have any condition that, in the opinion of the
investigator, may interfere with optimal participation in the study

- Have used any investigational drugs within 30 days of study entry

- Are participating in any other clinical treatment study

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

To assess the safety, toxicities and tolerability of a regimen of 3 mcg/kg weekly Sylatron with concurrent induction Yervoy at 3, then if well tolerated, at 10 mg/kg every three weeks four times, in participants with unresectable stages IIIC/IV melanoma, and to define a well tolerated dose of Yervoy in that combination, if any.

Outcome Time Frame:

48 Months

Safety Issue:


Principal Investigator

Jeffrey Weber, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2012

Completion Date:

February 2016

Related Keywords:

  • Melanoma
  • unresectable
  • stage 3
  • stage 4
  • autoimmune
  • antibodies
  • Melanoma



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612