Metastatic Uveal MelanomaPhase 2SUAVENCT01551459
A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
A Phase 2 study testing Dacarbazine and Sunitinib in people with Metastatic Uveal Melanoma, run by The Clatterbridge Cancer Centre NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Doctors usually treat uveal melanoma with radiotherapy or surgery. But if this cancer spreads, it is more difficult to treat. Doctors usually treat uveal melanoma that has spread with a chemotherapy called dacarbazine, but they are always looking to find new ways to treat uveal melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Uveal Melanoma
- What is being tested?
- Dacarbazine and Sunitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Nov 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
- Patients with histologically or cytologically confirmed unresectable, metastatic uveal melanoma (histology must be available from a metastatic site)
- Patients with disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent No prior systemic therapy for advanced disease, including regional delivery of drug therapy (prior surgery or radiofrequency ablation is acceptable)
- Patients who have received prior radiotherapy are eligible, however, measurable lesions must not have been previously irradiated
- Life expectancy > 12 weeks ECOG Performance status 0, 1 or 2
- At least one measurable target lesion, for further evaluation according to the Response Evaluation Criteria In Solid Tumours - RECIST version 1.1 completed within 28 days of randomisation
- Aged > 18 years
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- Adequate haematological, renal and liver function as defined below and performed within 14 days of study inclusion:
- Hb > 10 g/dl, platelets > 100 x109/L, WCC > 3.0 x109/L, ANC > 1.5x109/L, Bili < 1.5 x ULN, Alk phos < 5 x ULN, transaminases < 5 x ULN, Cr < 1.5 x ULN
- Able to provide written informed consent
- Females of child-bearing potential who have a negative pregnancy test prior to study entry and be using adequate contraception, which they agree to continue for 12 months after the study treatment
Who cannot join
- Patients who have:
- Conjunctival melanoma
- Received any previous systemic therapy for uveal melanoma
- Known leptomeningeal or brain metastases
- Patients with a history of prior malignant disease (unless they have had more than 3 years free of disease or have had adequately treated non-melanomatous skin cancer or in situ carcinoma of the cervix)
- Had treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days respectively, prior to study treatment administration
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- Therapeutic anticoagulation for treatment of DVT/PE. Concomitant treatment with therapeutic doses of anticoagulants (low dose warfarin up to 2mg PO daily for deep vein thrombosis prophylaxis is allowed)
- Unstable systemic diseases including uncontrolled hypertension (>150/100 mmHg despite optimal medical therapy) or active uncontrolled infections
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
- Clinically significant abnormal cardiac function with abnormal 12 lead ECG. Ongoing cardiac dysrhythmias of NCI CTCAE grade 2, poorly controlled atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females
- Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
- Any medical or psychiatric condition which would influence the ability to provide informed consent
- Pregnant or lactating women Lack of informed consent
- Any previous investigational agent within the last 12 weeks
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clatterbridge Centre for Oncology NHS Foundation Trust
Metropolitan Borough of Wirral, CH63 4JY
About this study
Official title: A Randomised Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
Doctors usually treat uveal melanoma with radiotherapy or surgery. But if this cancer spreads, it is more difficult to treat.
Doctors usually treat uveal melanoma that has spread with a chemotherapy called dacarbazine, but they are always looking to find new ways to treat uveal melanoma.
This study aims to find out how well Sunitinib works to treat uveal melanoma and to see how long Sunitinib and Dacarbazine can help to prevent the cancer from getting worse.
Read the detailed description
124 eligible patients will be randomised to either Sunitinib or Dacarbazine treatment. Participants will then attend 3-weekly clinic visits and undergo 12-weekly tumour assessment (CT or MRI scan) until disease progression (according to RECIST 1.1) has been identified.
At progression, patients may crossover to the other study treatment and continue with 3-weekly clinic visits and 12-weekly imaging until second progression.
- Conditions
- Metastatic Uveal Melanoma
- Being tested
- Dacarbazine, Sunitinib
- Keywords
- Uveal, Melanoma, Metastatic, Sunitinib
- Medical subject headings
- Uveal Melanoma, Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DacarbazineDrug
Also called DTIC
Dacarbazine: Patients will receive 1000mg/m2 every 21 days by IV until progression or unacceptable toxicity.
SunitinibDrug
Also called Sutent, Sunitinib Malate
Sunitinib: Patients will take 50mg orally once a day, for 28 days followed by a 14 day break, until progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Dacarbazine | Active comparator | Patients will receive 1000mg/m2 every 21 days by IV until progression or unacceptable toxicity. Receives: Drug: Dacarbazine |
| Arm 2: Sunitinib | Experimental | Sunitinib: Patients will take 50mg orally once a day, for 28 days followed by a 14 day break, until progression or unacceptable toxicity. Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The primary outcome measure for this trial is the progression-free survival time measured from date of randomisation. For patients with evidence of progressive disease (as measured by CT scan, or MRI if necessary) or patients who have died from any cause, progression-free survival time will be calculated to date of progressive disease or date of death (whichever occurs first) and will be counted as events in the analysis. Patients still alive with no evidence of progression at the time of their last visit are censored at the time of the most recent information.
Measured: Once all patients have been followed up for at least 3 months
Secondary outcomes (5)
Overall Survival
Overall survival will be measured from date of randomisation to the date of death from any cause. Patients still alive at the time of the analysis are censored at the date of the most recent follow-up.
Measured: Analysis will take place once all patients have been followed up for at least 3 months
Overall Response Rate
Overall response rate is defined as the proportion of complete (CR) or partial responders (PR) as defined by the RECIST version 1.1
Measured: Analysis will take place once all patients have been followed up for at least 3 months
Time to progression on first-line treatment compared to second-line treatment
Time to progression on first-line treatment compared to second-line treatment for patients who receive cross-over therapy.
Measured: Analysis will take place once all patients have been followed up for at least 3 months
Overall response rate on first-line treatment compared to overall response rate on second-line treatment for patients who receive cross-over therapy
Overall response rate on first-line treatment compared to overall response rate on second-line treatment for patients who receive cross-over therapy
Measured: Analysis will take place once all patients have been followed up for at least 3 months
Assessment of Adverse Events
Adverse Events recorded following randomisation will be classified using NCI CTCAE version 4.
Measured: Analysis will take place once all patients have been followed up for at least 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startOct 2010
- Primary completionSep 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Pfizer
- Responsible party
- Sponsor
- Investigators
- Ernest Marshall, Principal investigator, The Clatterbridge Cancer Centre NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551459
- Sponsor's protocol ID
- 2008-008794-55
- Other IDs
- 2008-008794-55, 8440, 75033520, 10/H0904/15, 2008
- Acronym
- SUAVE
- Status last verified
- May 2019
- First submitted
- 8 Mar 2012
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
- ClinicalTrials.gov ID
- NCT01551459
- Acronym / sponsor ID
- SUAVE / 2008-008794-55
- Conditions
- Metastatic Uveal Melanoma
- Keywords
- Uveal, Melanoma, Metastatic, Sunitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Cancer Research UK, Pfizer
- Study start
- Oct 2010
- Primary completion
- Sep 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Doctors usually treat uveal melanoma with radiotherapy or surgery. But if this cancer spreads, it is more difficult to treat.
Doctors usually treat uveal melanoma that has spread with a chemotherapy called dacarbazine, but they are always looking to find new ways to treat uveal melanoma.
This study aims to find out how well Sunitinib works to treat uveal melanoma and to see how long Sunitinib and Dacarbazine can help to prevent the cancer from getting worse.
Detailed description
124 eligible patients will be randomised to either Sunitinib or Dacarbazine treatment. Participants will then attend 3-weekly clinic visits and undergo 12-weekly tumour assessment (CT or MRI scan) until disease progression (according to RECIST 1.1) has been identified.
At progression, patients may crossover to the other study treatment and continue with 3-weekly clinic visits and 12-weekly imaging until second progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Dacarbazine | Active comparator | Drug: DacarbazinePatients will receive 1000mg/m2 every 21 days by IV until progression or unacceptable toxicity. |
| Arm 2: Sunitinib | Experimental | Drug: SunitinibSunitinib: Patients will take 50mg orally once a day, for 28 days followed by a 14 day break, until progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically or cytologically confirmed unresectable, metastatic uveal melanoma (histology must be available from a metastatic site)
- Patients with disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent No prior systemic therapy for advanced disease, including regional delivery of drug therapy (prior surgery or radiofrequency ablation is acceptable)
- Patients who have received prior radiotherapy are eligible, however, measurable lesions must not have been previously irradiated
- Life expectancy > 12 weeks ECOG Performance status 0, 1 or 2
- At least one measurable target lesion, for further evaluation according to the Response Evaluation Criteria In Solid Tumours - RECIST version 1.1 completed within 28 days of randomisation
Key exclusion criteria (14 listed)
- Conjunctival melanoma
- Received any previous systemic therapy for uveal melanoma
- Known leptomeningeal or brain metastases
- Patients with a history of prior malignant disease (unless they have had more than 3 years free of disease or have had adequately treated non-melanomatous skin cancer or in situ carcinoma of the cervix)
- Had treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days respectively, prior to study treatment administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DacarbazineAlso: DTICDacarbazine: Patients will receive 1000mg/m2 every 21 days by IV until progression or unacceptable toxicity. | Drug | Arm 1: Dacarbazine |
| SunitinibAlso: Sutent, Sunitinib MalateSunitinib: Patients will take 50mg orally once a day, for 28 days followed by a 14 day break, until progression or unacceptable toxicity | Drug | Arm 2: Sunitinib |
Primary outcome
Progression Free Survival
Time frame: Once all patients have been followed up for at least 3 months
The primary outcome measure for this trial is the progression-free survival time measured from date of randomisation. For patients with evidence of progressive disease (as measured by CT scan, or MRI if necessary) or patients who have died from any cause, progression-free survival time will be calculated to date of progressive disease or date of death (whichever occurs first) and will be counted as events in the analysis. Patients still alive with no evidence of progression at the time of their last visit are censored at the time of the most recent information.
5 secondary outcomes
Overall Survival
Time frame: Analysis will take place once all patients have been followed up for at least 3 months
Overall Response Rate
Time frame: Analysis will take place once all patients have been followed up for at least 3 months
Time to progression on first-line treatment compared to second-line treatment
Time frame: Analysis will take place once all patients have been followed up for at least 3 months
Overall response rate on first-line treatment compared to overall response rate on second-line treatment for patients who receive cross-over therapy
Time frame: Analysis will take place once all patients have been followed up for at least 3 months
Assessment of Adverse Events
Time frame: Analysis will take place once all patients have been followed up for at least 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Related Info: Liverpool Cancer Trials UnitLink provided by the sponsor.
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Safety and Efficacy Study in Adults With Advanced Solid Tumors Receiving REGN13089-M404-M2980, an Antibody-drug Conjugate That Targets MET Protein on Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest Marshall principal investigator
The Clatterbridge Cancer Centre NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dacarbazine and Sunitinib in people with Metastatic Uveal Melanoma, run by The Clatterbridge Cancer Centre NHS Foundation Trust at 1 site in United Kingdom.
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 10 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: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 (time frame: Once all patients have been followed up for at least 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2019.