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Completed

NCT Number: NCT00257205

CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Ciudad de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.
  • Serum lactic acid dehydrogenase (LDH) <= 2 x ULN
  • ECOG performance status of 0 or 1

Exclusion criteria

  • Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.
  • History of brain metastases

Treatment and study plan

Dacarbazine

Drug

decarbazine 1000 mg/m2 IV Q 21 days x 12

CP-675,206

Drug

CP-675,206 15 mg/kg IV Q 90 days x 4

Other names: anti-CTLA4 human monoclonal antibody

Temozolomide

Drug

temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12

Primary outcomes

  1. overall survival

    Time frame: August 2010

Secondary outcomes

  1. adverse events

    Time frame: 1 year

  2. PFS at 6 months

    Time frame: 6 months

  3. objective tumor response

    Time frame: 1 year

  4. Durable response

    Time frame: 6 months

  5. pharmacokinetics endpoints

    Time frame: 15 months

  6. pharmacogenomic endpoints

    Time frame: 1 year

  7. HQol

    Time frame: 1 year

  8. healthcare resource utilization and loss of productivity

    Time frame: 1 year

  9. human antihuman antibody response for patients in Arm A

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Nov 22, 2005
Registry last updated
Jul 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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