Completed

An Extended Dosing, Two-phase Study of MDX-010 as Monotherapy or in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 VG in the Treatment of Subjects With Resected Stage III or Stage IV Melanoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ipilimumab

+ Tyrosinase/gp100/MART-1 Peptides
Biological
Who is being recruted

Melanoma
+8

+ Neoplasms
+ Neoplasms by Histologic Type
From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 31, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Achieve at least a 40% autoimmune breakthrough event rate, as defined by the induction of grade 1, grade 2, or acceptable grade 3 drug-related autoimmune adverse events, in patients with resected stage III or IV melanoma treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51. Secondary * Determine the incidence of drug-related autoimmune adverse events of any grade in patients treated with this regimen. * Determine the time to disease relapse in patients treated with this regimen. * Determine the immunologic response in patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1 of weeks 1, 9, 17, 25, 33, 41, and 53 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51 subcutaneously on day 1 of weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Official TitleAn Extended Dosing, Two-phase Study of MDX-010 as Monotherapy or in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 VG in the Treatment of Subjects With Resected Stage III or Stage IV Melanoma 
NCT00084656
Principal SponsorBristol-Myers Squibb
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
77 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Skin Diseases
Skin Neoplasms
Neuroectodermal Tumors
Nevi and Melanomas
Neuroendocrine Tumors
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed melanoma * Stage III (≥ 3 positive lymph nodes) or stage IV disease * Mucosal or ocular melanoma allowed * Completely resected within the past 6 months * Patients with stage III resected melanoma rendered free of disease may have failed, been ineligible for, or refused prior treatment with interferon alfa * Positive staining of tumor tissue for at least one of the following: * Antibody HMB-45 for gp100 * Antibody HMB-45 for tyrosinase * Antibody HMB-45 for MART-1 * HLA-A\*0201 positive by DNA allele-specific polymerase chain reaction assay PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 6 months Hematopoietic * WBC ≥ 2,500/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hematocrit ≥ 30% * Hemoglobin ≥ 10 g/dL Hepatic * AST ≤ 3 times upper limit of normal (ULN)\* * Bilirubin ≤ ULN\* (\< 3.0 mg/dL for patients with Gilbert's syndrome) * No significant hepatic disease that would preclude study participation * Hepatitis B surface antigen negative * Hepatitis C antibody negative NOTE: \* Unless attributable to disease Renal * Creatinine ≤ 2.0 mg/dL * No significant renal disease that would preclude study participation Cardiovascular * No significant cardiac disease that would preclude study participation Pulmonary * No significant pulmonary disease that would preclude study participation Immunologic * No history of any of the following: * Inflammatory bowel disease or any other autoimmune bowel disease * Systemic lupus erythematosus * Rheumatoid arthritis * Autoimmune ocular disease * No systemic hypersensitivity to Montanide ISA-51 or any vaccine component * No active infection requiring therapy * HIV negative Other * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix * No significant gastrointestinal disease that would preclude study participation * No significant psychiatric disease that would preclude study participation * No other medical condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 4 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) * No prior gp100 antigen, MART-1 antigen, or tyrosinase peptide * At least 4 weeks since prior immunotherapy for melanoma and recovered * No other concurrent immunotherapy Chemotherapy * At least 4 weeks since prior chemotherapy for melanoma (6 weeks for nitrosoureas) and recovered * No concurrent chemotherapy Endocrine therapy * At least 4 weeks since prior hormonal therapy for melanoma and recovered * At least 4 weeks since prior systemic, inhaled, or topical corticosteroids * No concurrent systemic, inhaled, or topical corticosteroids Radiotherapy * At least 4 weeks since prior radiotherapy for melanoma and recovered Surgery * See Disease Characteristics * At least 4 weeks since prior surgery for melanoma and recovered Other * No concurrent immunosuppressive agents (e.g., cyclosporine and its analog) * Concurrent analgesic therapy allowed provided the dose is stable for the past 14 days


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental

IV over 90 mins on day 1, wks 1,9,17,25,33,41,53 Dose: 3 mg/kg (Part I), 10 mg/kg (Part II)

(All subjects in Part I and HLA-A\*0201 positive subjects only in Part II): SC, day 1 of wks 1,3,5,7,9,11,17, 21,25,33,41,53 Dose: 1 mg peptide emulsified in 1 mL Montanide ISA 51 VG.)
Study Objectives
Primary Objectives

Percentage of participants who experienced an irAE during the course of the study defined by the induction of Grade 1, Grade 2, or acceptable Grade 3 drug-related irAEs. For the purposes of this trial, acceptable drug-related irAEs are skin-related immune-mediated adverse events \< or = Grade 3 (potentially reversible inflammation \< Grade 4 that can be attributable to a local antitumor reaction that could potentially be a therapeutic response will also be considered an acceptable irAE). Note: The confidence interval was calculated using the Clopper Pearson method

To determine the time (months) from first dose to disease relapse. Time to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation. Median estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method.
Secondary Objectives

The number of participants who experienced a drug-related irAE of any grade over the course of the study. Note: The confidence interval was calculated using the Clopper Pearson method

The secondary objective was to determine the immunologic response to the dosing regimen, via Human Anti-Human Antibody (HAHA) Assessment, displayed by number of participants observed as HAHA positive or negative. Note: If participant had at least one post-baseline HAHA result with increase in titer over pre-study, the participant is counted as HAHA Positive. A participant with all negative post-baseline results is counted as HAHA negative.

The number of participants who experienced a Hematology-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study. Laboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.

The number of participants who experienced a Serum Chemistry-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study. Laboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.

To determine the time (months) from first dose to disease relapse. Time to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation. Median estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, United StatesSee the location

CompletedOne Study Center
;