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Metastatic MelanomaPhase 1/2NCT01689870

Study of the Combination of Anti-OX40 and Ipilimumab in Patients With Metastatic Melanoma

A Phase 1/2 study testing Anti-OX40 and Ipilimumab in people with Metastatic Melanoma, run by Ludwig Institute for Cancer Research.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an open label, two-phase study combining a dose escalation Phase 1 with a proof-of-concept Phase 2 in patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab is indicated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
Anti-OX40 and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2014to Aug 2014
Phase
Phase 1/2
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 with unresectable or metastatic melanoma, for whom treatment with Ipilimumab is indicated
  • Radiologically measurable disease by immune-related Response Criteria
  • ECOG performance status of 0-1.
  • Anticipated lifespan greater than 12 weeks.
  • At the time of day 1 of the study, patients must be at least 3 weeks since surgery
  • At the time of day 1 of the study, patients with brain metastases must be asymptomatic and, at least 8 weeks without tumor progression after any whole brain radiotherapy, at least 4 weeks since craniotomy and resection or stereotactic radiosurgery, at least 3 weeks without new brain metastases as evidenced by MRI/CT
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  • The following laboratory parameters must be within the ranges specified: Hemoglobin-≥ 9 g/dL, WBC-≥ 3.0 x 109/L, INR-≤ 1.5, Total Bilirubin-≤ 1.9 g/dL \& AST/ALT-≤ 3 x ULN
  • Have been informed of other treatment options.
  • At least 18 years. Able and willing to give valid written informed consent.

Who cannot join

  • Any contraindications for ipilimumab/Yervoy®.
  • Prior exposure to ipilimumab/Yervoy®
  • Prior exposure to Anti-OX40 or a mouse monoclonal antibody.
  • History of severe allergic reactions to any unknown allergens or anti-OX40 Autoimmune disease except for autoimmune thyroiditis or vitiligo.
  • Unresolved immune related adverse events following prior biological therapy.
  • Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
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  • Known immunodeficiency or HIV, Hepatitis B or Hepatitis C positivity.
  • Other serious illnesses (e.g., serious infections requiring antibiotics).
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to day 1 of the study.
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Lack of availability for immunological and clinical follow-up assessments.
  • Women who are breast feeding or pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 72 hours of first dosing.
  • Women of childbearing potential not using a medically acceptable means of contraception for the duration of the study.
  • Any condition that, in the clinical judgment of the treating physician, is likely to prevent the patient from complying with any aspect of the protocol or that may put the patient at unacceptable risk.

About this study

Official title: Phase 1/2 Study of the Combination of a Mouse Monoclonal Antibody to OX40 and Ipilimumab in Patients With Metastatic Melanoma

This is an open label, two-phase study combining a dose escalation Phase 1 with a proof-of-concept Phase 2 in patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab is indicated.

The purpose of the Phase 1 is to determine the Anti-OX40 Maximum Tolerated Dose (MTD) and the secondary objectives are anti-OX40 pharmacokinetics, biological activity and the tumor response assessed by the Immune-related Response Criteria.

The purpose of Phase 2 is to determine tumor response (by irRC) and the secondary objectives are anti-OX40 pharmacokinetics, biological activity and Safety/Tolerability.

Being tested
Anti-OX40, Ipilimumab
Keywords
OX40, Anti-OX40, Ipilimumab, Melanoma
Medical subject headings
Melanoma

What participants receive

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

  • Anti-OX40Drug

    Also called CD134 mab

    Anti-OX40 will be administered i.v. over 60 minutes only in the first week on Days 1, 3 and 5

  • IpilimumabDrug

    Also called YERVOY

    Ipilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1

Study groups in NCT01689870
Study groupRoleWhat they receive
Phase 1 Cohort 1ExperimentalIpilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1. Anti-OX40 will be administered at 0.1 mg/kg over 60 minutes only in the first week on Days 1, 3 and 5.
Receives: Drug: Anti-OX40; Drug: Ipilimumab
Phase 1 Cohort 2ExperimentalIpilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1. Anti-OX40 will be administered at 0.2 mg/kg over 60 minutes only in the first week on Days 1, 3 and 5.
Receives: Drug: Anti-OX40; Drug: Ipilimumab
Phase 1 Cohort 3ExperimentalIpilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1. Anti-OX40 will be administered at 0.4 mg/kg over 60 minutes only in the first week on Days 1, 3 and 5.
Receives: Drug: Anti-OX40; Drug: Ipilimumab
Phase 2 Cohort 4ExperimentalIpilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1. Anti-OX40 will be administered i.v. at the Phase 1 Maximum Tolerated Dose over 60 minutes only in the first week on Days 1, 3 and 5.
Receives: Drug: Anti-OX40; Drug: Ipilimumab

What is being measured

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

  1. Assess safety and tolerability according to the National Cancer Institute CTCAE v4.0 (Phase 1 and 2)

    Laboratory tests, vital sign measurements, physical exams and patient interviews will be performed to detect new abnormalities and deteriorations of any pre-existing conditions

    Measured: Up to 16 weeks

  2. Assess Tumor Response by the Immune-related Response Criteria (Phase 2)

    Tumor Response by irRC is defined as irPR or irCR over a period of at least 4 weeks

    Measured: Baseline, Week 12 & week 16

Secondary outcomes (2)

  1. Determine Anti-OX40 serum concentrations

    The serum concentration of Anti-OX40 (CD134) will be determined from its binding to OX40 as measured by ELISA

    Measured: Baseline, on days 1, 3 & 5 30 minutes after Anti-OX40 end of infusion, and on days 8 and 15

  2. Assess the biological activity of anti-OX40 in combination with ipilimumab

    The biological activity of anti-OX40 in combination with ipilimumab will be assessed by:

    • Determining immunologic changes in the tumor microenvironment by characterization of tumor-infiltrating lymphocytes (TILs), assessment of antigen-specific T cell responses and immunohistochemical (IHC) characterization of tumor and peri-tumoral tissue
    • Characterizing circulating T-cell subsets by flow cytometry
    • Assessing antigen specific immune responses by ELISA
    • Characterizing surface markers on lymphocytes and peripheral blood cells by flow cytometry
    • Measuring serum level of soluble factors (cytokine profiling)
    • mRNA/miRNA profiling to analyse gene transcription and/or miRNA expression

    Measured: Baseline, Day1, day 3, day 5 day8, day 15, day 22 day 43, day 64, day 85 & 113

Timeline

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

  1. First posted21 Sep 2012 (estimated)
  2. Study startMar 2014
  3. Primary completionJun 2014 (estimated)
  4. Study completionAug 2014 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01689870
Sponsor's protocol ID
LUD2012-005
Status last verified
Mar 2014
First submitted
18 Sep 2012
Last updated
1 Apr 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Anti-OX40 and Ipilimumab in people with Metastatic Melanoma, run by Ludwig Institute for Cancer Research.

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 14 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: withdrawn, as of the sponsor's last update on 1 Apr 2014. 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 combined 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.

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?

Assess safety and tolerability according to the National Cancer Institute CTCAE v4.0 (Phase 1 and 2) (time frame: Up to 16 weeks). The study lists 2 primary outcomes in all. 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 NCT01689870.

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 1 Apr 2014.

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