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Malignant MelanomaPhase 1NCT00729950

Study of MDX-010 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma

A Phase 1 study testing MDX-010 in people with Malignant Melanoma, run by Bristol-Myers Squibb at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase I, open-label, multicenter, pharmacokinetic study of MDX-010 in up to 90 evaluable subjects with surgically unresectable malignant melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
MDX-010
How many people
92 participants
Where
4 sitesUnited States
Study dates
Jul 2003to Jun 2007
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

  • Subject must have read, understood, and provided written informed consent and authorization in compliance with the Health Insurance Portability and Accountability Act (HIPAA) afer the nature of the study has been fully explained.
  • Subject must be at least 18 years of age with a histologic diagnosis of unresectable Stage III or IV malignant melanoma (may include mucosal melanoma). Subjects with either stable or progressive malignancy will be permitted in the study. Classification of stable or progressive disease, to be recorded for all subjects, will be defined by the Response Evaluation Criteria in Solid Tumors (RECIST), as detailed in Appendix 3 and determined since last melanoma treatment. Subjects must have at least 1 site of measurable disease.
  • At least 4 weeks since treatment (surgery, chemotherapy, radiation, or immuno- therapy) for melanoma and recovered from any serious toxicity experienced during treatment.
  • Life expectancy of at least 18 weeks.
  • Karnofsky Performance Status of at least 70%
  • Screening laboratory values must meet the following criteria:
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  • WBC ≥2500/μL
  • ANC ≥1500/μL
  • Platelets ≥100 x 10'/μL
  • Hematocrit ≥30%
  • Hemoglobin ≥10 g/dL
  • Creatinine ≤2 mg/dL
  • AST ≤2 x ULN*
  • Bilirubin ≤1.0 x ULN*, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
  • HIV negative
  • HBsAg negative
  • anti-HCV nonreactive. If reactive, subject must have a negative HCV RNA qualitative PCR.
  • Unless definitely attributable to disease.

Who cannot join

  • Any prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer from which the subject has been disease-free for at least 5 years
  • History of autoimmune disease (including uveitis and autoimmune inflammatory eye disease) prior to entrance into the study.
  • Active infection requiring therapy, chronic active HBV or HCV, or confirmed reactivity with HIV tests.
  • Tetanus booster immunization within 2 months of initial screening procedures, or a history of anaphylaxis or severe local reaction to the tetanus vaccine.
  • Pregnant or nursing: it is not known what effect MDX-010 could have on the developing immune system of the fetus or infant, therefore, exposure in utero or via breast milk will not be allowed.
  • Any underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events.
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  • Any concurrent medical condition requiring the use of systemic or topical corticosteroids or the use of immunosuppressive agents (e.g. cyclosporine and its analog, or chemotherapy agents). All corticosteroid use must have been discontinued at least 4 weeks prior to trial entry.
  • Prior treatment with MDX-010 or any other anti-CTLA-4 monoclonal antibody.
  • Evidence or history of significant cardiac, pulmonary, hepatic, renal, psychiatric or gastrointestinal disease that would make the administration of MDX-010 unsafe.
  • Concurrent treatment with chemotherapy or other immunotherapy regimens (must be completed at least 4 weeks before Screening).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Piedmont Oncology Specialists

    Charlotte, North Carolina, 28207

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Arizona Cancer Center

    Tucson, Arizona, 85724-5024

Other trials in United States

About this study

Official title: An Open-Label Pharmacokinetic and Safety Study of MDX-010 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma

This is a Phase I, open-label, multicenter, pharmacokinetic study of MDX-010 in up to 90 evaluable subjects with surgically unresectable malignant melanoma.

Read the detailed description

Group A: Six to 12 subjects will be treated with transfectoma-derived MDX-010 at 2.8 or 5 mg/kg/dose, or with hybridoma-derived MDX-010 at 3 mg/kg/dose administered on Days 1, 57, and 85. The 2.8, 3, and 5 mg/kg dosage cohorts may be initiated concurrently. Additionally, 6 subjects per cohort will receive single doses of transfectoma-derived MDX-010 at 7.5, 10, 15, and 20 mg/kg.

Dose escalation from the 5 mg/kg cohort to the 7.5 mg/kg cohort will depend on the safety profile following a single dose of 5 mg/kg. Once all subjects are enrolled in the 5 mg/kg cohort and 4 weeks have elapsed since the sixth subject in the cohort has received the first infusion, dose escalation to the 7.5 mg/kg cohort may occur if ≤1 DLT has occurred in the 5 mg/kg cohort. Dose escalation to the 10 mg/kg cohort may occur 4 weeks after the sixth subject in the 7.5 mg/kg/dose cohort has received the first infusion (with ≤1 DLT). Dose escalation to the 15 and 20 mg/kg cohorts may occur 4 weeks after the sixth subject in the previous cohort has received the first infusion (with ≤1 DLT). Up to six additional subjects may be enrolled in the MTD dose cohort or in the 20 mg/kg dose cohort if MTD is not attained.

Group B: If single-dose administration of MDX-010 at 10 mg/kg is well tolerated (≤1 DLT in the cohort in Group A), then an additional 12 to 20 subjects will be enrolled and treated with MDX-010 at 10 mg/kg/dose administered on Days 1, 22, 43, and 64.

Subjects who respond to therapy will be followed until disease progression or a maximum of approximately 1 year. Subjects with a response of SD ≥ 3 months, PR, or CR to their initial treatment cycle who subsequently relapse may be eligible for retreatment with the same regimen or an alternate regimen considered to be more effective at the time of retreatment.

Being tested
MDX-010
Medical subject headings
Melanoma

What participants receive

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

  • MDX-010Biological

    Subjects will be treated with transfectoma-derived MDX-010 at 2.8 or 5 mg/kg/dose, or with hybridoma-derived MDX-010 at 3 mg/kg/dose administered on Days 1, 57, and 85. The 2.8, 3, and 5 mg/kg dosage cohorts may be initiated concurrently. Additionally, 6 subjects per cohort will receive single doses of transfectoma-derived MDX-010 at 7.5, 10, 15, and 20 mg/kg.

What is being measured

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

  1. To determine the safety and pharmacokinetic profile of single and multiple doses of MDX-010.

    Measured: up to approximately 1 year

Secondary outcomes (1)

  1. Determine the clinical activity profile of single and multiple doses of MDX-010

    Measured: up to aproximately one year.

Timeline

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

  1. First posted8 Aug 2008 (estimated)
  2. Study startJul 2003
  3. Primary completionOct 2005
  4. Study completionJun 2007

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00729950
Sponsor's protocol ID
MDX010-15
Other IDs
CA184-001
Status last verified
Apr 2010
First submitted
6 Aug 2008
Last updated
26 Apr 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MDX-010 in people with Malignant Melanoma, run by Bristol-Myers Squibb 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 18 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: finished, as of the sponsor's last update on 26 Apr 2010. 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 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?

To determine the safety and pharmacokinetic profile of single and multiple doses of MDX-010. (time frame: up to approximately 1 year). 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 NCT00729950.

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 26 Apr 2010.

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