Intraocular MelanomaPhase 2NCT00084656
Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
A Phase 2 study testing ipilimumab and Tyrosinase/gp100/MART-1 Peptides in people with Intraocular Melanoma and Melanoma (Skin), run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines may make the body build an immune response to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Intraocular Melanoma, Melanoma (Skin)
- What is being tested?
- ipilimumab and Tyrosinase/gp100/MART-1 Peptides
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2004to 31 Oct 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497
About this study
Official title: 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
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Giving monoclonal antibody therapy together with vaccine therapy may be an effective treatment for stage III or stage IV melanoma.
PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with vaccine therapy works in treating patients with resected stage III or stage IV melanoma.
Read the detailed description
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.
- Conditions
- Intraocular Melanoma, Melanoma (Skin)
- Being tested
- ipilimumab, Tyrosinase/gp100/MART-1 Peptides
- Keywords
- stage III melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent melanoma, recurrent intraocular melanoma, metastatic intraocular melanoma
- Medical subject headings
- Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ipilimumabBiological
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)
Tyrosinase/gp100/MART-1 PeptidesBiological
(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 group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Biological: ipilimumab; Biological: Tyrosinase/gp100/MART-1 Peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Immune-related Adverse Events (irAEs)
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
Measured: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)
Time to Disease Relapse
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.
Measured: up to 3 years
Secondary outcomes (5)
Number of Participants With Drug-related irAEs of Any Grade
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
Measured: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)
Immunologic Response to the Dose Regimen
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.
Measured: up to 3 years
Number of Participants Experiencing Hematology-related Lab Abnormalities
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.
Measured: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
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.
Measured: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)
Time to Disease Relapse
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.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study start31 May 2004
- Primary completion31 Oct 2009
- Study completion31 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intraocular MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084656
- Sponsor's protocol ID
- CDR0000365467
- Other IDs
- P30CA076292, P30CA014089, MCC-15241, MDX010-16, NCI-6446, CA184-016
- Status last verified
- Apr 2022
- First submitted
- 10 Jun 2004
- Last updated
- 14 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Garg SK, Ott MJ, Mostofa AGM, Chen Z, Chen YA, Kroeger J, Cao B, Mailloux AW, Agrawal A, Schaible BJ, Sarnaik A, Weber JS, Berglund AE, Mule JJ, Markowitz J. Multi-Dimensional Flow Cytometry Analyses Reveal a Dichotomous Role for Nitric Oxide in Melanoma Patients Receiving Immunotherapy. Front Immunol. 2020 Feb 25;11:164. doi: 10.3389/fimmu.2020.00164. eCollection 2020.
PubMed 32161584Sarnaik AA, Yu B, Yu D, Morelli D, Hall M, Bogle D, Yan L, Targan S, Solomon J, Nichol G, Yellin M, Weber JS. Extended dose ipilimumab with a peptide vaccine: immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma. Clin Cancer Res. 2011 Feb 15;17(4):896-906. doi: 10.1158/1078-0432.CCR-10-2463. Epub 2010 Nov 24.
PubMed 21106722
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00084656
- Acronym / sponsor ID
- CDR0000365467
- Conditions
- Intraocular Melanoma, Melanoma (Skin)
- Keywords
- stage III melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent melanoma, recurrent intraocular melanoma, metastatic intraocular melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 May 2004 (actual)
- Primary completion
- 31 Oct 2009 (actual)
- Study completion
- 31 Oct 2009 (actual)
- First posted
- 11 Jun 2004 (estimated)
- Results
- Posted 14 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Giving monoclonal antibody therapy together with vaccine therapy may be an effective treatment for stage III or stage IV melanoma.
PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with vaccine therapy works in treating patients with resected stage III or stage IV melanoma.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: ipilimumab, Biological: Tyrosinase/gp100/MART-1 Peptides |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ipilimumabIV 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) | Biological | Arm 1 |
| Tyrosinase/gp100/MART-1 Peptides(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.) | Biological | Arm 1 |
Primary outcome
Percentage of Participants With Immune-related Adverse Events (irAEs)
Time frame: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)
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
Time to Disease Relapse
Time frame: up to 3 years
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.
5 secondary outcomes
Number of Participants With Drug-related irAEs of Any Grade
Time frame: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)
Immunologic Response to the Dose Regimen
Time frame: up to 3 years
Number of Participants Experiencing Hematology-related Lab Abnormalities
Time frame: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
Time frame: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)
Time to Disease Relapse
Time frame: up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32161584Garg SK, Ott MJ, Mostofa AGM, Chen Z, Chen YA, Kroeger J, Cao B, Mailloux AW, Agrawal A, Schaible BJ, Sarnaik A, Weber JS, Berglund AE, Mule JJ, Markowitz J. Multi-Dimensional Flow Cytometry Analyses Reveal a Dichotomous Role for Nitric Oxide in Melanoma Patients Receiving Immunotherapy. Front Immunol. 2020 Feb 25;11:164. doi: 10.3389/fimmu.2020.00164. eCollection 2020.
- Derived from this study: PubMed 21106722Sarnaik AA, Yu B, Yu D, Morelli D, Hall M, Bogle D, Yan L, Targan S, Solomon J, Nichol G, Yellin M, Weber JS. Extended dose ipilimumab with a peptide vaccine: immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma. Clin Cancer Res. 2011 Feb 15;17(4):896-906. doi: 10.1158/1078-0432.CCR-10-2463. Epub 2010 Nov 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ipilimumab and Tyrosinase/gp100/MART-1 Peptides in people with Intraocular Melanoma and Melanoma (Skin), run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Immune-related Adverse Events (irAEs) (time frame: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00084656, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.