Melanoma (Skin)Phase 2NCT00357461
Ipilimumab With or Without Vaccine Therapy in Treating Patients With Previously Treated Stage IV Melanoma
A Phase 2 study testing gp100:209-217(210M) peptide vaccine, gp100:280-288(288V) peptide vaccine and incomplete Freund's adjuvant in people with Melanoma (Skin), run by Bristol-Myers Squibb.
Trial summary
RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- gp100:209-217(210M) peptide vaccine, gp100:280-288(288V) peptide vaccine and incomplete Freund's adjuvant
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2006to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV melanoma
- HLA-A*0201 positive disease
- Previously treated metastatic disease
- Clinically evaluable and measurable disease
- No mucosal or ocular melanoma
- No evidence of active brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- WBC ≥ 2,500/mm³
- Absolute neutrophil count ≥ 1,000/mm³
- Absolute lymphocyte count ≥ 500/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin ≥ 9 g/dL
- Creatinine < 2.5 mg/dL
- AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Bilirubin normal (< 3.0 mg/dL if Gilbert's syndrome is present)
- Hepatitis B surface antigen negative
- HIV negativity
- No hepatitis C virus antibodies
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior malignancy except for any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- Superficial bladder cancer
- Carcinoma in situ of the cervix
- Any other cancer from which patient has been disease free for > 5 years
- No active immune-mediated disease requiring active therapy with any form of steroid or immunosuppressive therapy
- No documented history of any of the following:
- Inflammatory bowel disease
- Regional enteritis
- Connective tissue disorders, such as systemic lupus erythematosus
- Rheumatoid arthritis
- Immune-mediated inflammatory eye disease
- Sjögren's syndrome
- Inflammatory neurologic disorder, such as multiple sclerosis
- Any immune-mediated disease that can cause life-threatening symptoms or severe organ/tissue damage, in the opinion of the principal investigator
- History of vitiligo or immune-mediated thyroiditis allowed
- Skin rashes associated with previous therapy allowed provided patient has recovered from treatment-related toxicity to < grade 1
- No active infection
- No systemic hypersensitivity to any of the study drugs
- History of local reactions (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 allowed
- No underlying medical condition that, in the opinion of the investigator, would preclude study treatment
PRIOR CONCURRENT THERAPY:
- At least 3 weeks since prior systemic treatment (6 weeks for nitrosoureas) and recovered
- No prior ipilimumab or gp100 vaccines
- More than 4 weeks since prior steroids
- No concurrent systemic or topical corticosteroids or immunosuppressive agents (e.g., cyclosporine or chemotherapy agents), including steroid enemas, inhaled steroids, or steroid eye drops
- Hormone-replacement therapy allowed
About this study
Official title: A Randomized Phase II Study of Fixed Dose Ipilimumab (MDX-010) 10 mg/kg Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 VG for Previously Treated HLA-A * 0201 Positive Subjects With Stage IV Melanoma
RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Vaccines made from gp100 peptides may help the body build an effective immune response to kill tumor cells. Giving ipilimumab together with vaccine therapy may be an effective treatment for melanoma.
PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how well they work compared to ipilimumab alone in treating patients with previously treated stage IV melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Compare the impact of ipilimumab with vs without gp100 peptides emulsified with Montanide ISA-51 on clinical response in patients with previously treated, HLA-A*0201 positive stage IV melanoma.
Secondary
- Compare the safety/toxicity profile of these regimens in these patients.
- Determine the immunologic response, as measured by in vitro assays using peripheral blood samples, in patients treated with these regimens.
- Determine the response rate after a re-induction regimen for patients who have relapsed after initial response.
- Determine overall survival.
OUTLINE: This is a randomized, open-label study. Patients are stratified according to ECOG performance status (0 vs 1 or 2) and metastases (M1a vs M1 b or M1c). Patients are randomized to 1 of 2 treatment arms.
- Induction phase:
- Arm I: Patients receive ipilimumab IV over 90 minutes on day 1.
- Arm II: Patients receive ipilimumab as in arm I. Patients also receive gp100 peptides emulsified in Montanide ISA-51 subcutaneously (SC) on day 1.
In both arms, treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better for 12 weeks after 4 courses proceed to maintenance phase.
- Maintenance phase:
- Arm I: Patients receive ipilimumab IV over 90 minutes on day 1.
- Arm II: Patients receive ipilimumab IV as in arm I and gp100 peptides emulsified in Montanide ISA-51 SC on day 1.
Treatment in both arms begins in approximately week 21 and repeats every 3 months for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who relapse or progress while on maintenance phase undergo re-induction comprising 4 courses of treatment with ipilimumab with or without gp100 peptides emulsified in Montanide ISA-51 as in induction phase. Patients achieving responding disease (complete response, partial response, or stable disease) for 12 weeks after re-induction proceed to the maintenance phase as above for up to 8 courses of treatment.
After completion of study treatment, patients are evaluated for 3 weeks after the last treatment, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- gp100:209-217(210M) peptide vaccine, gp100:280-288(288V) peptide vaccine, incomplete Freund's adjuvant, ipilimumab
- Keywords
- stage IV melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gp100:209-217(210M) peptide vaccineBiological
gp100:280-288(288V) peptide vaccineBiological
incomplete Freund's adjuvantBiological
ipilimumabBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Secondary outcomes (4)
Safety and toxicity
Immunologic response
Response rate
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies 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
- Randomised
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Steven A. Rosenberg, MD, PhD, Principal investigator, NCI - Surgery Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357461
- Sponsor's protocol ID
- CDR0000486705
- Other IDs
- NCI-06-C-0159, NCI-P6951, MDX-NCI-06-C-0159
- Status last verified
- May 2013
- First submitted
- 26 Jul 2006
- Last updated
- 15 May 2013
- Results posted
- No
Publications
Downey SG, Klapper JA, Smith FO, Yang JC, Sherry RM, Royal RE, Kammula US, Hughes MS, Allen TE, Levy CL, Yellin M, Nichol G, White DE, Steinberg SM, Rosenberg SA. Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 blockade. Clin Cancer Res. 2007 Nov 15;13(22 Pt 1):6681-8. doi: 10.1158/1078-0432.CCR-07-0187. Epub 2007 Nov 2.
PubMed 17982122
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Fixed Dose Ipilimumab (MDX-010) 10 mg/kg Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 VG for Previously Treated HLA-A * 0201 Positive Subjects With Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT00357461
- Acronym / sponsor ID
- CDR0000486705
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma, recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2006
- First posted
- 27 Jul 2006 (estimated)
- Results
- Not posted in the source record
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, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Vaccines made from gp100 peptides may help the body build an effective immune response to kill tumor cells. Giving ipilimumab together with vaccine therapy may be an effective treatment for melanoma.
PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how well they work compared to ipilimumab alone in treating patients with previously treated stage IV melanoma.
Detailed description
OBJECTIVES:
Primary
- Compare the impact of ipilimumab with vs without gp100 peptides emulsified with Montanide ISA-51 on clinical response in patients with previously treated, HLA-A*0201 positive stage IV melanoma.
Secondary
- Compare the safety/toxicity profile of these regimens in these patients.
- Determine the immunologic response, as measured by in vitro assays using peripheral blood samples, in patients treated with these regimens.
- Determine the response rate after a re-induction regimen for patients who have relapsed after initial response.
- Determine overall survival.
OUTLINE: This is a randomized, open-label study. Patients are stratified according to ECOG performance status (0 vs 1 or 2) and metastases (M1a vs M1 b or M1c). Patients are randomized to 1 of 2 treatment arms.
- Induction phase:
- Arm I: Patients receive ipilimumab IV over 90 minutes on day 1.
- Arm II: Patients receive ipilimumab as in arm I. Patients also receive gp100 peptides emulsified in Montanide ISA-51 subcutaneously (SC) on day 1.
In both arms, treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better for 12 weeks after 4 courses proceed to maintenance phase.
- Maintenance phase:
- Arm I: Patients receive ipilimumab IV over 90 minutes on day 1.
- Arm II: Patients receive ipilimumab IV as in arm I and gp100 peptides emulsified in Montanide ISA-51 SC on day 1.
Treatment in both arms begins in approximately week 21 and repeats every 3 months for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who relapse or progress while on maintenance phase undergo re-induction comprising 4 courses of treatment with ipilimumab with or without gp100 peptides emulsified in Montanide ISA-51 as in induction phase. Patients achieving responding disease (complete response, partial response, or stable disease) for 12 weeks after re-induction proceed to the maintenance phase as above for up to 8 courses of treatment.
After completion of study treatment, patients are evaluated for 3 weeks after the last treatment, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| gp100:209-217(210M) peptide vaccine | Biological | – |
| gp100:280-288(288V) peptide vaccine | Biological | – |
| incomplete Freund's adjuvant | Biological | – |
| ipilimumab | Biological | – |
Primary outcome
Clinical response
4 secondary outcomes
Safety and toxicity
Immunologic response
Response rate
Overall survival
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
- Background: PubMed 17982122Downey SG, Klapper JA, Smith FO, Yang JC, Sherry RM, Royal RE, Kammula US, Hughes MS, Allen TE, Levy CL, Yellin M, Nichol G, White DE, Steinberg SM, Rosenberg SA. Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 blockade. Clin Cancer Res. 2007 Nov 15;13(22 Pt 1):6681-8. doi: 10.1158/1078-0432.CCR-07-0187. Epub 2007 Nov 2.
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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.
Steven A. Rosenberg, MD, PhD principal investigator
NCI - Surgery Branch
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gp100:209-217(210M) peptide vaccine, gp100:280-288(288V) peptide vaccine and incomplete Freund's adjuvant in people with Melanoma (Skin), run by Bristol-Myers Squibb.
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: withdrawn, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical response. 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 NCT00357461, which also lists 1 linked publication.
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 15 May 2013.