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Uveal MelanomaPhase 2NCT01034787

Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

A Phase 2 study testing CP-675,206 in people with Uveal Melanoma, run by AHS Cancer Control Alberta at 3 sites in Canada.

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 2, multi-center, open-label study in patients with surgically incurable stage III or IV uveal melanoma who have not received prior immunotherapy. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Uveal Melanoma
What is being tested?
CP-675,206
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
3 sitesCanada
Study dates
17 Aug 2009to 8 Aug 2017
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 uveal melanoma including choroidal melanoma, iris melanoma, and ciliary body melanoma
  • Patients may either have measurable disease or non-measurable disease.
  • Biopsies from a readily accessible site of disease on study enrollment are mandatory in principle. Waivers will be granted if there are no accessible lesions. The collection of a representative block of the diagnostic tumour tissue (if available) is mandatory.
  • ECOG performance status of 0 or 1
  • Age 18 years or older
  • Adequate bone marrow, hepatic, and renal function determined within 14 days prior to registration, defined as:
Show all 12Show fewer
  • Serum lactic acid dehydrogenase (LDH) </= 1.5 x ULN.
  • Alkaline phosphatase (ALP) </= 2 x ULN.
  • No weight loss >/= 10% in the proceeding 4 weeks.
  • CT scan of the brain with contrast or MRI of the brain within 28 days of registration showing no evidence of brain metastases.
  • Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
  • Females of childbearing potential and males who have not undergone surgical sterilization must agree to practice a form of effective contraception prior to entry into the study and for 12 months following the last dose of study drug. The definition of effective contraception will be based on the judgment of the investigator.

Who cannot join

  • Melanoma of cutaneous, mucosal or conjunctival origin.
  • History of brain or leptomeningeal metastases.
  • Received any prior CTLA4 inhibiting agent (eg MDX-010, ipilimumab) or other immunotherapy.
  • History of chronic inflammatory or autoimmune disease
  • History of uveitis or melanoma-associated retinopathy.
  • History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.
  • History of hepatitis due to Hepatitis B virus or Hepatitis C virus

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

This is a Phase 2, multi-center, open-label study in patients with surgically incurable stage III or IV uveal melanoma who have not received prior immunotherapy. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 has been shown to induce durable tumor responses in patients with metastatic melanoma in phase 1 and phase 2 clinical studies.

Read the detailed description

This is a Phase 2, multi-center, open-label study in patients with surgically incurable stage III or IV uveal melanoma who have not received prior immunotherapy. Patients may have received prior chemotherapy or biological therapy for the treatment of advanced disease. Twenty-nine patients will be enrolled. Patients may have either measurable disease or non-measurable disease.

Patients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of every 90-day cycle for up to 4 cycles or until disease progression or intolerance of toxicity. Each cycle is defined as a 90 +/- 4 days period. Patients should be weighed within 10 days prior to each cycle and the administered dose of CP-675,206 should be recalculated.

Patients who complete 4 doses of CP-675,206 without disease progression and who subsequently experience disease progression more than 3 months after the last dose may receive 4 additional doses of CP-675,206 provided that they have not received other systemic therapy for their melanoma. Patients with clinical benefit may be considered for additional dosing if evidence emerges supporting ongoing maintenance therapy.

Tumor assessments will be done every 3 months. All patients with objective tumor response must have additional scans scheduled 4-6 weeks after the criteria for response are first met in order to confirm the response. Additional scans will be done if clinically indicated. Survival will be monitored on all patients for up to 5 years from the date of first dose of CP-675,206. The follow up time may be adjusted based on ongoing studies using CP-675,206 for melanoma.

An exploratory study will be conducted to identify micro environmental features in the tumor that are permissive of tumor immunity (i.e: those associated with a "response" to anti-CTLA4) and to assess whether anti-CTLA4 causes peripheral mobilization of immunomodulatory inflammatory cells.

Conditions
Uveal Melanoma
Being tested
CP-675,206
Keywords
CP-675,206, Immunotherapy, AntiCTLA4, Clinical Trial, Unresectable or Metastatic
Medical subject headings
Uveal Melanoma, Neoplasm Metastasis

What participants receive

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

  • CP-675,206Drug

    Patients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of ever 90 cycle for up to 4 cycles or until progression or intolerance of toxicity. Tumor assessments will be done ever 3 months. Additional scans will be done if clinically indicated.

Study groups in NCT01034787
Study groupRoleWhat they receive
Open Label CP-675,206ExperimentalPatients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of every 90-day cycle for up to 4 cycles or until disease progression or intolerance of toxicity.
Receives: Drug: CP-675,206

What is being measured

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

  1. Progression-free survival at 6 months after initiation of CP-675,206

    A 6-month progression free survivor will be defined as a patient who is alive and who has not progressed at 6 months or more post treatment.

    Measured: 6 months

Secondary outcomes (4)

  1. Objective tumor response

    Duration of Objective response (CR or PR) for responding patients will be measured from the date of registration to the date of progression or death due to progressive disease, whichever occurs first. In addition, the Duration of Complete Response will be measured from the date that a CR was first documented to the date of progression or death due to progressive disease, whichever occurs first.

    Measured: overall

  2. Durable response

    Durable response is defined as an objective tumor response that last 6 or more months

    Measured: 6 or more months

  3. Median survival and overall survival

    • Overall Survival (OS) is defined as the time from the date of registration to date of death by any cause. In the absence of confirmation of death, survival time will be censored at the last date the patient was known to be alive.

    Measured: overall

  4. Adverse events and tolerability

    Following the first dose, adverse events should be continuously assessed and documented during the study reporting period. Adverse events will be followed up to and including the End of Treatment visit. Additionally, all adverse events with a causal relationship to the study drug must be followed until the event and its sequalae have resolved, returned to baseline, been deemed irreversible, or until the patient dies.

    Measured: overall

Timeline

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

  1. First posted17 Dec 2009 (estimated)
  2. Study start17 Aug 2009
  3. Primary completion8 Aug 2017
  4. Study completion8 Aug 2017

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01034787
Sponsor's protocol ID
TBCC 905001
Status last verified
Oct 2017
First submitted
15 Dec 2009
Last updated
27 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Rietschel P, Panageas KS, Hanlon C, Patel A, Abramson DH, Chapman PB. Variates of survival in metastatic uveal melanoma. J Clin Oncol. 2005 Nov 1;23(31):8076-80. doi: 10.1200/JCO.2005.02.6534.

    PubMed 16258106

  • Bedikian AY, Legha SS, Mavligit G, Carrasco CH, Khorana S, Plager C, Papadopoulos N, Benjamin RS. Treatment of uveal melanoma metastatic to the liver: a review of the M. D. Anderson Cancer Center experience and prognostic factors. Cancer. 1995 Nov 1;76(9):1665-70. doi: 10.1002/1097-0142(19951101)76:93.0.co;2-j.

    PubMed 8635073

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP-675,206 in people with Uveal Melanoma, run by AHS Cancer Control Alberta at 3 sites in Canada.

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 12 inclusion and 7 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. 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?

Progression-free survival at 6 months after initiation of CP-675,206 (time frame: 6 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 NCT01034787, which also lists 2 linked publications.

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 27 Oct 2017.

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