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Stage III MelanomaPhase 2NCT01026051

Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma

A Phase 2 study testing MKC1106-MT in people with Stage III Melanoma and Stage IV Melanoma, run by Mannkind Corporation at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The clinical trial is evaluating a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on melanoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage III Melanoma, Stage IV Melanoma
What is being tested?
MKC1106-MT
Type of treatment
Vaccines
How many people
5 participants
Where
4 sitesUnited States
Study dates
Oct 2010to Jul 2012
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of regional or distant metastatic melanoma (stage IIIB, IIIC, or IV) confined to skin, subcutaneous tissue, or lymph nodes that is refractory to standard of care, or for which no curative standard therapy exists (Note: Subjects who are therapy-naïve will also be eligible.)
  • Measurable disease by the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria
  • ECOG performance status of 0 or 1
  • Life expectancy > or = 3 months
  • 18 years of age or older at screening evaluation
  • Subjects must be able to provide informed consent for participation in the clinical trial before any protocol-specific clinical trial procedure is performed
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  • Positive for HLA-A2 and, more precisely, for expression of A*0201 as assessed by DNA typing
  • Tumor material from prior biopsy/surgical resection available for analysis of expression of melanoma specific antigens
  • Adequate coagulation function as evidenced by prothrombin time (PT) and partial thromboplastin time (PTT) values within the normal range
  • Adequate bone marrow reserve as evidenced by Absolute neutrophil count (ANC) > or = 1,000/mL; platelet count > or = 75,000/mL
  • 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 drug.
  • Subjects who have received local radiation therapy (less than one-fourth of bone marrow) are eligible.

Who cannot join

  • Subjects with visceral metastasis (Note: Subjects with stable CNS metastasis or fully treated CNS metastatic disease [eg, radiation therapy] are eligible.)
  • Active infection requiring treatment
  • Systemic inflammatory disease requiring chronic maintenance or suppressive therapy
  • Positive antibody test result for HIV, hepatitis B, or hepatitis C
  • History of allogeneic transplant
  • Medical, sociological, or psychological conditions that may compromise compliance or participation or that may interfere with the interpretation of the results
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  • History of receiving immunosuppressive drugs within 1 month before dosing
  • Subjects who are lactating, pregnant, or planning to become pregnant within 3 months of completing treatment
  • Subjects who received an investigational drug within the 4 weeks before dosing
  • Prior systemic radiation therapy (more than one-fourth of bone marrow)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

  • UCLA Medical Center

    Los Angeles, California, 90034

  • Martin Memorial

    Stuart, Florida, 34994

Other trials in United States

About this study

Official title: A Phase 2, Open Label, Non-Randomized Study to Evaluate the Safety, Tolerability, Immune Response and Clinical Response of Multiple Doses of MKC1106-MT in Subjects With Advanced Melanoma

The clinical trial is evaluating a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on melanoma

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 non-diseased superficial inguinal lymph nodes under ultrasound guidance

Being tested
MKC1106-MT
Keywords
Cancer Vaccine, Immunotherapy, Melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MKC1106-MTBiological

    Cancer Vaccine, Immunotherapy, Melanoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the objective response, where response is defined as either complete response (CR), partial response (PR), or stable disease (SD) for 12 weeks or longer (CR, PR, and SD are defined according to RECIST 1.1 criteria)

    Measured: 12 Months

Secondary outcomes (3)

  1. To assess clinical efficacy of MKC1106-MT in subjects with advanced melanoma measured at 6 months and 1 year by (1) time to progression, progression-free survival

    Measured: 12 Months

  2. To identify and characterize correlations between biological activity (immune response), target antigen expression and clinical efficacy.

    Measured: 12 months

  3. To further assess the safety profile and tolerability

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2009 (estimated)
  2. Study startOct 2010
  3. Primary completionSep 2011
  4. Study completionJul 2012 (estimated)

Why it stopped: Financial/Business Reasons

Resources

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
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01026051
Sponsor's protocol ID
MKC1106-MT-002
Status last verified
May 2012
First submitted
3 Dec 2009
Last updated
15 May 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MKC1106-MT in people with Stage III Melanoma and Stage IV Melanoma, run by Mannkind Corporation at 4 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 13 inclusion and 10 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: stopped early, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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 stopped early (reason given: Financial/Business Reasons). Results are not available in the source record.

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?

To evaluate the objective response, where response is defined as either complete response (CR), partial response (PR), or stable disease (SD) for 12 weeks or longer (CR, PR, and SD are defined according to RECIST 1.1 criteria) (time frame: 12 Months). 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 NCT01026051.

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 2012.

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