Advanced MelanomaPhase 1NCT00688090
Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma.
A Phase 1 study testing Biological: MKC1106-MT and Biological: MKCC1106-MT in people with Advanced Melanoma and Stage III and IV Melanoma, run by Mannkind Corporation at 2 sites in United States.
Trial summary
A dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on melanomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma, Stage III and IV Melanoma
- What is being tested?
- Biological: MKC1106-MT and Biological: MKCC1106-MT
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to May 2010
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of locally advanced or metastatic melanoma (American Joint Committee on Cancer [AJCC 6th edition] stage IIIB, IIIC or IV) that is refractory to standard therapy or for which no curative standard therapy exists.
- Patients enrolled in the Phase 2 portion of the trial must have measurable disease by the RECIST criteria ECOG performance status of 0 or 1 Life expectancy = 3 months 18 years of age or older at screening evaluation Positive for HLA-A2, and more precisely, express A0201 as assessed by DNA typing Tumor material from prior biopsy / surgical resection available for analysis of expression of melanoma specific antigens Adequate bone marrow reserve as evidenced by: Absolute neutrophil count (ANC) = 1,000/?L \& Platelet count = 75,000/?L Adequate renal function as evidenced by: serum creatinine = 1.5 mg/dL Adequate hepatic function as evidenced by: Serum total bilirubin = 2.0 mg/dL \& SGOT/SGPT = 3 times the ULN for the reference lab (= 5 the ULN for the reference lab for subjects with known hepatic metastases) Subjects must have recovered to at least baseline or Grade 1 toxicity from the effects of any prior surgery, radiotherapy or other therapies including but not limited to chemotherapy Women of childbearing potential as well as fertile men and their partners must agree to use an effective method of contraception or to abstain from sexual intercourse during the clinical trial and for 90 days following the last dose of the investigational new drug Subjects must be able to provide informed consent for participation in the clinical trial before any protocol-specific clinical trial procedure is performed
Who cannot join
- No systemic infection requiring treatment Symptomatic brain metastases and/or progression of CNS metastases within the past 4 weeks; patients with treated CNS metastases (by surgery and/or radiation), who are neurologically stable, and who are no longer taking glucocorticoids, are eligible Subjects with autoimmune disorders, including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, Sjogren's syndrome, mixed connective tissue disease, ankylosing spondylitis, Hashimoto's thyroiditis, bullous pemphigus, sarcoidosis, Behçet's syndrome, vasculitis, familial Mediterranean fever, Wegener's granulomatosis or Goodpasture's syndrome Positive HIV, hepatitis B or hepatitis C antibody test Subjects who underwent allogeneic transplant New York Heart Association Grade III or IV congestive heart failure Medical, sociological or psychological conditions that may compromise compliance or participation in the clinical trial or interfere with the interpretation of the results Subjects who have taken drugs that negatively affect immune function such as systemic corticosteroids or other immunomodulatory drugs including, but not limited to, interferon-alpha, interferon-beta, interleukin-2, etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept or efalizumab, within one month preceding the screening Subjects who are lactating, pregnant, or planning to become pregnant within three months of treatment completion Subjects who have received any investigational drug within the preceding four weeks of enrollment Subjects who have affected inguinal lymph nodes (metastatic process) or lack of inguinal lymph nodes (resection)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA Medical Center
Los Angeles, California, 90034
H Lee Moffitt Cancer Center University of So Florida
Tampa, Florida, 33612
About this study
Official title: A Phase 1/2, Open Label, Non-Randomized Dose Escalation Study to Evaluate the Safety, Tolerability, Immune Response and Clinical Response of Multiple Doses of MKC1106-MT in Subjects With Advanced Melanoma
A dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on melanomas.
Read the detailed description
The multi-component active immunotherapy, MKC1106-MT, consists of 1 plasmid dose and 2 peptides doses designed to stimulate an immune reaction to two tumor associated antigens (Melan-A and tyrosinase). The plasmid component will be administered on Days 1,4, 15 and 18 of each treatment cycle followed by administration of peptides on Days 29 and 32 of the treatment cycle. All components will be administered separately into superficial inguinal lymph nodes under ultrasound guidance.
- Conditions
- Advanced Melanoma, Stage III and IV Melanoma
- Being tested
- Biological: MKC1106-MT, Biological: MKCC1106-MT
- Keywords
- Immunotherapy, Melanoma, Cancer Vaccine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: MKC1106-MTBiological
Cancer Vaccine, Immunotherapy
Biological: MKCC1106-MTBiological
Cancer Vaccine, Immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Peptide Cohort | Experimental | Not described Receives: Biological: Biological: MKCC1106-MT |
| High-Dose Peptide Cohort | Experimental | Not described Receives: Biological: Biological: MKC1106-MT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is to assess the safety and tolerability of MKC1106-MT regimen
Measured: 6 weeks
Secondary outcomes (4)
To assess the immune response (by tetramer and ELISPOT analysis) of MKC1106-MT when administered to subjects with advanced melanoma
Measured: 6 Weeks
To determine pMEL-TYR plasmid level in the blood by PCR analysis
Measured: 6 Weeks
To determine target antigen expression (Melan A and tyrosinase) and beta2 microglobulin expression in the tumor tissue
Measured: 6 Weeks
To document any preliminary evidence of clinical response
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688090
- Sponsor's protocol ID
- MKC1106-MT-001
- Status last verified
- Aug 2010
- First submitted
- 28 May 2008
- Last updated
- 3 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open Label, Non-Randomized Dose Escalation Study to Evaluate the Safety, Tolerability, Immune Response and Clinical Response of Multiple Doses of MKC1106-MT in Subjects With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00688090
- Acronym / sponsor ID
- MKC1106-MT-001
- Conditions
- Advanced Melanoma, Stage III and IV Melanoma
- Keywords
- Immunotherapy, Melanoma, Cancer Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Jun 2008 (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.
A dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on melanomas.
Detailed description
The multi-component active immunotherapy, MKC1106-MT, consists of 1 plasmid dose and 2 peptides doses designed to stimulate an immune reaction to two tumor associated antigens (Melan-A and tyrosinase). The plasmid component will be administered on Days 1,4, 15 and 18 of each treatment cycle followed by administration of peptides on Days 29 and 32 of the treatment cycle. All components will be administered separately into superficial inguinal lymph nodes under ultrasound guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Peptide Cohort | Experimental | Biological: Biological: MKCC1106-MT |
| High-Dose Peptide Cohort | Experimental | Biological: Biological: MKC1106-MT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of locally advanced or metastatic melanoma (American Joint Committee on Cancer [AJCC 6th edition] stage IIIB, IIIC or IV) that is refractory to standard therapy or for which no curative standard therapy exists.
- Patients enrolled in the Phase 2 portion of the trial must have measurable disease by the RECIST criteria ECOG performance status of 0 or 1 Life expectancy = 3 months 18 years of age or older at screening evaluation Positive for HLA-A2, and more precisely, express A0201 as assessed by DNA typing Tumor material from prior biopsy / surgical resection available for analysis of expression of melanoma specific antigens Adequate bone marrow reserve as evidenced by: Absolute neutrophil count (ANC) = 1,000/?L \& Platelet count = 75,000/?L Adequate renal function as evidenced by: serum creatinine = 1.5 mg/dL Adequate hepatic function as evidenced by: Serum total bilirubin = 2.0 mg/dL \& SGOT/SGPT = 3 times the ULN for the reference lab (= 5 the ULN for the reference lab for subjects with known hepatic metastases) Subjects must have recovered to at least baseline or Grade 1 toxicity from the effects of any prior surgery, radiotherapy or other therapies including but not limited to chemotherapy Women of childbearing potential as well as fertile men and their partners must agree to use an effective method of contraception or to abstain from sexual intercourse during the clinical trial and for 90 days following the last dose of the investigational new drug Subjects must be able to provide informed consent for participation in the clinical trial before any protocol-specific clinical trial procedure is performed
Key exclusion criteria (1 listed)
- No systemic infection requiring treatment Symptomatic brain metastases and/or progression of CNS metastases within the past 4 weeks; patients with treated CNS metastases (by surgery and/or radiation), who are neurologically stable, and who are no longer taking glucocorticoids, are eligible Subjects with autoimmune disorders, including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, Sjogren's syndrome, mixed connective tissue disease, ankylosing spondylitis, Hashimoto's thyroiditis, bullous pemphigus, sarcoidosis, Behçet's syndrome, vasculitis, familial Mediterranean fever, Wegener's granulomatosis or Goodpasture's syndrome Positive HIV, hepatitis B or hepatitis C antibody test Subjects who underwent allogeneic transplant New York Heart Association Grade III or IV congestive heart failure Medical, sociological or psychological conditions that may compromise compliance or participation in the clinical trial or interfere with the interpretation of the results Subjects who have taken drugs that negatively affect immune function such as systemic corticosteroids or other immunomodulatory drugs including, but not limited to, interferon-alpha, interferon-beta, interleukin-2, etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept or efalizumab, within one month preceding the screening Subjects who are lactating, pregnant, or planning to become pregnant within three months of treatment completion Subjects who have received any investigational drug within the preceding four weeks of enrollment Subjects who have affected inguinal lymph nodes (metastatic process) or lack of inguinal lymph nodes (resection)
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 |
|---|---|---|
| Biological: MKC1106-MTCancer Vaccine, Immunotherapy | Biological | High-Dose Peptide Cohort |
| Biological: MKCC1106-MTCancer Vaccine, Immunotherapy | Biological | Low-Dose Peptide Cohort |
Primary outcome
Is to assess the safety and tolerability of MKC1106-MT regimen
Time frame: 6 weeks
4 secondary outcomes
To assess the immune response (by tetramer and ELISPOT analysis) of MKC1106-MT when administered to subjects with advanced melanoma
Time frame: 6 Weeks
To determine pMEL-TYR plasmid level in the blood by PCR analysis
Time frame: 6 Weeks
To determine target antigen expression (Melan A and tyrosinase) and beta2 microglobulin expression in the tumor tissue
Time frame: 6 Weeks
To document any preliminary evidence of clinical response
Time frame: 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2010.
Related trials for Advanced Melanoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of BI 3810944 in Patients With Advanced Cancer
Solid Tumours, Melanoma
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
RecruitingPhase 1/2
A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
Melanoma, Solid Tumors
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biological: MKC1106-MT and Biological: MKCC1106-MT in people with Advanced Melanoma and Stage III and IV Melanoma, run by Mannkind Corporation at 2 sites 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 3 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Is to assess the safety and tolerability of MKC1106-MT regimen (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2010.