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AzTrials

MelanomaPhase 1NCT00790010

Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma

A Phase 1 study testing Bevacizumab Plus Ipilimumab Cohort 1, Bevacizumab Plus Ipilimumab Cohort 2 and Bevacizumab Plus Ipilimumab Cohort 3 in people with Melanoma, run by Dana-Farber Cancer Institute at 3 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

The purpose of this research study is to determine the safety of using the study drugs bevacizumab and ipilimumab together, and the doses in combination which can be given to people safely. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Bevacizumab Plus Ipilimumab Cohort 1, Bevacizumab Plus Ipilimumab Cohort 2 and Bevacizumab Plus Ipilimumab Cohort 3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
3 sitesUnited States
Study dates
26 Feb 2009to 22 Jun 2018
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

  • Measurable unresectable Stage III or Stage IV melanoma
  • ECOG Performance Status 0 or 1
  • 4 weeks or greater since treatment
  • Must have recovered from any acute toxicity associated with prior therapy
  • Life expectancy of greater than 12 weeks
  • 18 years of age or older
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  • Laboratory values as outlined in protocol
  • Negative screening tests for HIV, active Hepatitis B and Hepatitis C
  • Patients who received prior therapy with anthracyclines should have a baseline MUGA or echo with a normal ejection fraction

Who cannot join

  • CNS metastases
  • Pregnant or nursing women
  • Prior therapy with bevacizumab or ipilimumab
  • Active infection
  • Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic autoimmune disease
  • Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
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  • Any underlying medical condition which, in the principal investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events
  • Any concurrent medical condition requiring the use of systemic steroids
  • Inadequately controlled hypertension
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • NYHA Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • History of stroke of transient ischemic attack within 6 months prior to study enrollment
  • Significant known vascular disease
  • Symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Major surgical procedure or significant traumatic injury within 28 days prior to study enrollment
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  • Serious, non-healing wound, ulcer or bone fracture
  • Proteinuria at screening
  • Known hypersensitivity to any component of bevacizumab
  • History of hemoptysis within 3 months prior to study enrollment
  • Current, ongoing treatment with full-dose warfarin or its equivalent
  • Current or recent (within 10 days of enrollment) use of aspirin (>325mg/day) or chronic use of other NSAIDs
  • Medications that inhibit platelet function
  • Known involvement of melanoma within gastrointestinal tract
  • Ulcerated skin lesions

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Massachusetts General Hospital

    Boston, Massachusetts, 02214

Other trials in United States

About this study

Official title: A Phase I Trial of Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma

The purpose of this research study is to determine the safety of using the study drugs bevacizumab and ipilimumab together, and the doses in combination which can be given to people safely. This study also seeks to investigate whether using both study drugs lengthens the amount of time before the participants melanoma worsens.

Read the detailed description
  • There are two phases to this research study, Induction Phase and Maintenance Phase.
  • Induction Phase: Participants will receive ipilimumab by an infusion into a vein or central line at weeks 1, 4, 7 and 10 for a total of 4 infusions. Bevacizumab is also given as an infusion into a vein or central line at weeks 1, 4, 7 and 10 along with ipilimumab and then every 3 weeks by itself. During all cycles of study therapy, the participant will have a physical exam on the first day and undergo blood tests at every study visit. At weeks 1, 4, 7, 10 and 12 a urine sample will be obtained for analysis.
  • Chest, abdomen and pelvic CT scans will be performed at week 12. If the scans at week 12 show that the participants cancer has remained stable or decreased, they will be asked to have repeat CT scans in three months.
  • Positron Emission Tomography (PET) scans will be done at week 8 and week 16.
  • Maintenance Phase: If the scans performed at week 12 show the cancer has improved or stayed the same, then the participant will continue to receive bevacizumab every three weeks and undergo a CT scan every 3 months. Also, every 3 months the participant may be eligible to receive additional doses of ipilimumab in addition to the bevacizumab.
Conditions
Melanoma
Being tested
Bevacizumab Plus Ipilimumab Cohort 1, Bevacizumab Plus Ipilimumab Cohort 2, Bevacizumab Plus Ipilimumab Cohort 3, Bevacizumab Plus Ipilimumab Cohort 4
Keywords
bevacizumab, ipilimumab, unresectable stage III melanoma, unresectable stage IV melanoma
Medical subject headings
Melanoma

What participants receive

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

  • Bevacizumab Plus Ipilimumab Cohort 1Drug

    Also called Bevacizumab- also known as Avastin, Ipilimumab-also known as MDX-010 or MDX-101 & marketed as Yervoy

    Cohort 1: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous)

  • Bevacizumab Plus Ipilimumab Cohort 2Drug

    Also called Bevacizumab- also known as Avastin, Ipilimumab-also known as MDX-010 or MDX-101 & marketed as Yervoy

    Cohort 2: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous)

  • Bevacizumab Plus Ipilimumab Cohort 3Drug

    Also called Bevacizumab- also known as Avastin, Ipilimumab-also known as MDX-010 or MDX-101 & marketed as Yervoy

    Cohort 3: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous)

  • Bevacizumab Plus Ipilimumab Cohort 4Drug

    Also called Bevacizumab- also known as Avastin, Ipilimumab-also known as MDX-010 or MDX-101 & marketed as Yervoy

    Cohort 4: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous)

Study groups in NCT00790010
Study groupRoleWhat they receive
Bevacizumab Plus Ipilimumab Cohort 1Experimental5 subjects for this cohort
Receives: Drug: Bevacizumab Plus Ipilimumab Cohort 1
Bevacizumab Plus Ipilimumab Cohort 2Experimental17 subects for this cohort
Receives: Drug: Bevacizumab Plus Ipilimumab Cohort 2
Bevacizumab Plus Ipilimumab Cohort 3Experimental12 subjects
Receives: Drug: Bevacizumab Plus Ipilimumab Cohort 3
Bevacizumab Plus Ipilimumab Cohort 4Experimental12 subjects
Receives: Drug: Bevacizumab Plus Ipilimumab Cohort 4

What is being measured

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

  1. To determine the safety, tolerability and maximum tolerated dosing for the combination of bevacizumab plus ipilimumab in patients with unresectable stage III or stage IV melanoma

    Measured: 3 years

Secondary outcomes (2)

  1. To determine the best overall response rate by standard solid tumor response criteria, disease control rate, time to tumor progression, and duration of response for the combination of bevacizumab plus ipilimumab in this patient population

    Measured: 3 years

  2. To perform correlative studies investigating the effects of this combination therapy on antitumor immunity and tumor vasculature

    Measured: 3 years

Timeline

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

  1. First posted13 Nov 2008 (estimated)
  2. Study start26 Feb 2009
  3. Primary completion22 Jun 2018
  4. Study completion22 Jun 2018

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
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790010
Sponsor's protocol ID
08-142
Other IDs
CA184-058, AVF 4122s
Status last verified
May 2023
First submitted
12 Nov 2008
Last updated
11 May 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bevacizumab Plus Ipilimumab Cohort 1, Bevacizumab Plus Ipilimumab Cohort 2 and Bevacizumab Plus Ipilimumab Cohort 3 in people with Melanoma, run by Dana-Farber Cancer Institute at 3 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 9 inclusion and 28 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 11 May 2023. 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 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, tolerability and maximum tolerated dosing for the combination of bevacizumab plus ipilimumab in patients with unresectable stage III or stage IV melanoma (time frame: 3 years). 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 NCT00790010.

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 11 May 2023.

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