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Stage III MelanomaPhase 2NCT01376713

Anti-CD20 (Cluster of Differentiation Antigen 20) Therapy to Treat Metastatic Melanoma

A Phase 2 study testing Ofatumumab and Ofatumumab plus Dacarbazine in people with Stage III Melanoma and Stage IV Melanoma, run by Medical University of Vienna at 2 sites in Austria.

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

The purpose of this study is to assess the overall disease control rate of Ofatumumab wo/w Dacarbazine in subjects with American Joint Committee on Cancer (AJCC 2009) unresectable stage III or stage IV 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?
Ofatumumab and Ofatumumab plus Dacarbazine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesAustria
Study dates
Jun 2011to May 2015
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

  • Patients older than 18 years
  • Signed informed consent
  • Metastatic non-ocular melanoma - unresectable stage III B (T1- 4a, N2b-c), stage III C (AJCC 2009) or stage IV (AJCC 2009).
  • measurable disease with more than one metastatic lesion, according to RECIST v. 1.1 criteria,
  • One of these metastases must be resectable prior to anti-CD20 therapy.
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
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  • As soon as BRAF or other kinase inhibitors are standard of care, we will include only patients who cannot be considered for those therapies. E.g. patients with tumors not carrying the respective mutational profile, patients refusing this kind of therapy for any reason, patients being not eligible to those therapies due to contraindications or disease progression under such kind of therapy.
  • Life expectancy of 3 month or longer
  • Negative pregnancy test in female patients of childbearing potential and adequate contraception in female patients of childbearing age.

Who cannot join

  • Patients with active brain metastasis (exception: brain metastases being stable with and without corticosteroids for 2 months after treatment by surgery or radiation therapy) and immunoglobulin-deficiency will be excluded.
  • Subjects meeting any of the following criteria must not be enrolled in an ofatumumab study:
  • Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
  • Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
  • Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
  • Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
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  • History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
  • HIV positive
  • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to enrollment, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
  • Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
  • Positive serology for hepatitis C (HC) defined as a positive test for HCAb (HC antibodies), in which case reflexively perform a HC RIBA (recombinant immunoblot assay) on the same sample to confirm the result
  • Screening laboratory values:
  • hemoglobin < 8g/dL platelets <70 x 109/L leukocytes <1.5 x 109/L creatinine >2.0 times ULN (upper limit of normal) total bilirubin >1.5 times ULN liver transaminase ALT >2.5 times ULN alkaline phosphatase >2.5 times ULN
  • Pregnant or lactating women
  • Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy

Trial locations and contacts

2 sites in 1 country.

Austria2 sites

  • Rudolfstiftung

    Vienna, 1030

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: CD20-Immunotargeting in Metastatic Melanoma Patients- A Prospective, Open Label, Sequential Pilot Study

The purpose of this study is to assess the overall disease control rate of Ofatumumab wo/w Dacarbazine in subjects with American Joint Committee on Cancer (AJCC 2009) unresectable stage III or stage IV melanoma.

Read the detailed description

This is a prospective, multicenter, open-label, sequential, 2-cohort, phase 2 study to assess the overall disease control rate of Ofatumumab according to criteria of RECIST (Response Evaluation Criteria in Solid Tumors) v. 1.1. in subjects with unresectable stage III B (T1- 4a, N2b-c), stage III C or stage IV (American Joint Committee on Cancer 2009) disease.

Cohort 1: 10 eligible patients will be treated with ofatumumab alone. If interim analysis shows that at least 1 confirmed overall response occurs, an additional 19 eligible patients will be treated, for a total of 29 patients.

Cohort 2: If no confirmed overall response by ofatumumab alone-therapy is seen in the first 10 patients, cohort 2 will be opened. Initially, 13 eligible patients will be treated with a combination of Dacarbazine plus ofatumumab. If interim analysis gives at least 2 confirmed overall responses, additional 26 patients will be recruited.

Being tested
Ofatumumab, Ofatumumab plus Dacarbazine
Keywords
Melanoma
Medical subject headings
Melanoma

What participants receive

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

  • OfatumumabBiological

    Also called Arzerra

    Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks

  • Ofatumumab plus DacarbazineBiological

    Also called Arzerra, DTIC

    Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks.

    Dacarbazine administered q4w at a dose of 1000mg/m2, 4 days before next administration of Ofatumumab for 24 weeks.

Study groups in NCT01376713
Study groupRoleWhat they receive
Ofatumumab aloneExperimentalPatients with melanoma unresectable stage III B (T1- 4a, N2b-c), stage III C or stage IV (AJCC 2009) will be included in this study. Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks. Tumor imaging is performed at wk 4 (screening for rapid disease progression), 8, 16 and 24. In case of PD, patients will have the opportunity to receive at least 3 cycles of ofatumumab q4w in combination with DTIC (1000 mg/m2) q4w (see Arm2).
Receives: Biological: Ofatumumab
Ofatumumab plus DacarbazineExperimentalPatients will be treated with a combination of DTIC (1000 mg/m2) q4w plus ofatumumab (1000mg) qw for 8 wks, and thereafter q4w.Tumor imaging is performed at wk 8, 16 and 24.
Receives: Biological: Ofatumumab plus Dacarbazine

What is being measured

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

  1. Disease control according to RECIST v. 1.1 criteria

    Disease control according to RECIST v. 1.1 criteria until week 24

    Measured: 24 weeks

Secondary outcomes (4)

  1. Assessment of progression-free survival (PFS)

    Assessment of progression-free survival (PFS) defined as the time from first day of treatment to the first documentation of disease progression or death, whichever occurs first.

    Measured: approximately 2 years

  2. Evaluation of cell biological responses

    in patients' blood and tumor samples

    Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks

  3. Duration of disease control

    Measured: approximately 2 years

  4. Overall survival

    Measured: approximately 2 years

Timeline

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

  1. First posted20 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJan 2015
  4. Study completionMay 2015

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01376713
Sponsor's protocol ID
EudraCT: 2010-023277-19
Status last verified
Oct 2015
First submitted
16 Jun 2011
Last updated
6 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Balch CM, Gershenwald JE, Soong SJ, Thompson JF, Atkins MB, Byrd DR, Buzaid AC, Cochran AJ, Coit DG, Ding S, Eggermont AM, Flaherty KT, Gimotty PA, Kirkwood JM, McMasters KM, Mihm MC Jr, Morton DL, Ross MI, Sober AJ, Sondak VK. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol. 2009 Dec 20;27(36):6199-206. doi: 10.1200/JCO.2009.23.4799. Epub 2009 Nov 16.

    PubMed 19917835

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ofatumumab and Ofatumumab plus Dacarbazine in people with Stage III Melanoma and Stage IV Melanoma, run by Medical University of Vienna at 2 sites in Austria.

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 9 inclusion and 15 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 6 Oct 2015. 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 Austria. 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 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?

Disease control according to RECIST v. 1.1 criteria (time frame: 24 weeks). 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 NCT01376713, 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 6 Oct 2015.

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