Overview

This trial is active, not recruiting.

Condition malignant melanoma
Treatment cancervax vaccine (canvaxin)
Phase phase 3
Sponsor CancerVax Corporation
Trial size 670 participants
Trial identifier NCT00052156, CV-MMAIT-4-001, JWCI-MC-4-001, NCT00003722

Summary

This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

- Must have Stage IV melanoma - Must have had all clinically-detectable disease surgically removed - Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. Some corticosteroids, and certain types of radiation therapy) - Cannot have HIV or Hepatitis A, B, or C

Additional Information

Official title A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by CancerVax Corporation.