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

Unresectable Stage III or Stage IV Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412828
• Other study ID #: CR011-CLN-11
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 18, 2006
• Last updated: February 2, 2015
• Start date: June 2006
• Est. completion date: May 2011

Study information

• Verified date: February 2015
• Source: Celldex Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 m2

• 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 composition.

• 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

Study Design

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

Related Conditions & MeSH terms

• Melanoma
• Unresectable Stage III or Stage IV Melanoma

Intervention

Drug:
• CR011-vcMMAE
administered as an intravenous infusion of 250 mL over 90 min

Locations

Country	Name	City	State
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	Yale University	New Haven	Connecticut
United States	New York University Medical Center	New York	New York
United States	Angeles Clinic and Research Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
CuraGen Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ott PA, Hamid O, Pavlick AC, Kluger H, Kim KB, Boasberg PD, Simantov R, Crowley E, Green JA, Hawthorne T, Davis TA, Sznol M, Hwu P. Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with advanced melanoma. J Clin Oncol. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)		throughout the study	No
Secondary	to evaluate the immune response to CR011-vcMMAE		throughout the study	No
Secondary	to assess the pharmacodynamics and pharmacokinetics of CRO11-vcMMAE		throughout the study	No
Secondary	to explore clinical anti-tumor response of CR011-vcMMAE in subjects with advanced metastatic melanoma		throughout the study	No

External Links

•   Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with advanced melanoma.