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A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

Phase 1/Phase 2
18 Years
Not Enrolling
Unresectable Stage III or Stage IV Melanoma

Thank you

Trial Information

A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

Inclusion Criteria:

- Male or female with age ≥ 18 years.

- Progressive or new metastatic melanoma, stage III or IV.

- Measurable disease by CT / MRI

- Failure of no more than 1 line of prior cytotoxic therapy.

- Adequate bone marrow, renal and hepatic function

- Leukocytes ≥ 3000/mm3, ANC ≥ 1,500 cells/mm3, Platelets ≥ 100,000/mm3

- Hemoglobin ≥ 10 g/dL (transfusion allowed)

- Total bilirubin ≤ 1.5 x upper normal limit (UNL)

- AST (SGOT), ALT (SGPT) ≤ 3.0 x UNL (≤ 5.0 x UNL may be acceptable)

- Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance > 45 mL/min/1.73

- PT/aPTT < 1.5 x UNL or within therapeutic range via anti-coagulation therapy

- Karnofsky PS ≥ 70%.

- Estimated life expectancy > 3 months.

- Signed informed consent approved IRB and ability to comply with the study or
monitoring procedures.

- Subjects with evaluable disease are eligible in dose-escalation cohorts

Exclusion Criteria:

- Prior therapies for disease under study less than 4 weeks prior to enrollment.

- Major surgery or trauma within 4 weeks of enrollment.

- Active brain metastases

- Active chronic inflammatory, autoimmunity, immunodeficiency disease, and vascular or
hemorrhagic disorders.

- History of allergic reactions to dolastatin, auristatin or compounds of similar

- Significant cardiovascular disease

- Other malignancies

- Pregnancy or breast feeding

- Refusal or inability to use effective means of contraception (for men, and women with
childbearing potential)

- History of or test-positive to HIV, or hepatitis B or C

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)

Outcome Time Frame:

throughout the study

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

May 2011

Related Keywords:

  • Unresectable Stage III or Stage IV Melanoma
  • Melanoma
  • CR011-vcMMAE
  • Melanoma



New York University Medical Center New York, New York  10016
Yale University New Haven, Connecticut  06520
M.D. Anderson Cancer Center Houston, Texas  77030
Angeles Clinic and Research Institute Santa Monica, California  90404