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MelanomaPhase 1NCT01496807

Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma

A Phase 1 study testing Sylatron and Yervoy in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site 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 study is to see how much of the drug Yervoy can be safely tolerated when it is given to people who are also receiving a drug called Sylatron. Investigators also wish to find out whether the addition of Yervoy increases the chance that Sylatron will cause a rise in the level of antibodies in the… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Melanoma
What is being tested?
Sylatron and Yervoy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
17 Feb 2012to 29 Aug 2016
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Must have cytologically or histologically-confirmed and unresectable melanoma, previously untreated systemically other than a BRAF inhibitor for metastatic disease, meeting one of the following American Joint Committee on Cancer (AJCC) staging criteria: AJCC Stage IV (Tany,Nany,M1); AJCC Stage IIIB/C patients with unresectable nodal/locoregional involvement; Patients with cutaneous, ocular or mucosal melanoma are eligible
  • Must have adequate hepatic, renal and bone marrow function as defined by the following parameters obtained within 4 weeks prior to initiation of study treatment. Hematologic Criteria: white blood count (WBC) >/= 3.0 x 10^9/L, Platelet > 100 x 10^9/L, Hemoglobin >/= 9 g/dL or 5.6 mmol/L; Renal and Hepatic Functional Criteria: Serum creatinine < 2.0 mg/dL or < 140 μmol/L, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) < 2 times upper normal limit of laboratory normal (ULN)
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Must give informed consent according to institutional policy
  • Must be willing to give written informed consent and must be able to adhere to dose and visit schedules
  • Female patients of childbearing potential must be using a medically accepted method of birth control prior to Screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation). Females of childbearing potential should be counseled in the appropriate use of birth control while in this study. Females who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.
  • Female patients of childbearing potential must have a negative serum pregnancy test (beta-hCG) at Screening.

Who cannot join

  • Female patients who are pregnant, intend to become pregnant, or are nursing
  • Previously treated with interferon alpha 2b, Sylatron or Yervoy therapy for melanoma
  • Patients whose disease can be completely surgically resected
  • Have not recovered from the effects of recent surgery
  • Patients with a history of prior malignancy within the past 2 years other than surgically cured squamous or basal cell carcinoma of the skin, or cervical carcinoma in situ
  • Have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease
Show all 18Show fewer
  • Patients with thyroid dysfunction not responsive to therapy
  • Patients who, in the opinion of the investigator, have uncontrolled diabetes mellitus
  • Suffering from an active autoimmune disease except medically controlled hypothyroidism and vitiligo
  • An active and/or uncontrolled infection, including active hepatitis
  • Have a history of seropositivity for HIV
  • Pre-existing psychiatric condition, including but not limited to: History of severe depression (including Hospitalization for depression, Electroconvulsive therapy for depression, Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions); Suicidal of homicidal ideation and/or suicidal or homicidal attempt; History of severe psychiatric disorders (e.g., psychosis, post-traumatic stress disorder or mania); Past history or current use of lithium and/or antipsychotic drugs
  • A clinical diagnosis of substance abuse of the one or more of the following drugs, within the following timeframes, (not including time spent in detoxification, hospitalization or incarceration): Alcohol, intravenous drug use (IVDU), inhalational, psychotropics, narcotics, cocaine, prescription or over-the-counter drugs: within 1 year of the Screening visit; Receiving methadone, buprenorphine hydrochloride (HCL), and/or butorphanol tartrate within 1 year of Screening visit, unless participant has drug screen negative for other (non-narcotic) drugs documented in past year and repeated negative within 2 months of Screening visit; Multi-drug abuse (2 or more substances in 17a and 17b) within 3 years of Screening visit; If the patient's historic marijuana use is deemed excessive by the principal investigator (PI), or medically qualified individual or is interfering with the patient's life, then the patient is not eligible and should not be screened. If patient's marijuana use is not deemed excessive by PI and does not interfere with life, the patient must be instructed to discontinue any current use of recreational marijuana prior to entry into study.
  • Patients with a medical condition requiring chronic systemic corticosteroids
  • Known to be allergic to the drug substance or any of the excipients in the Sylatron or Yervoy formulation
  • Patients who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
  • Have used any investigational drugs within 30 days of study entry
  • Are participating in any other clinical treatment study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase Ib Study of Yervoy With Sylatron for Patients With Unresectable Stages IIIB/C/IV Melanoma

The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when it is given to people who are also receiving a drug called Sylatron. Investigators also wish to find out whether the addition of Yervoy increases the chance that Sylatron will cause a rise in the level of antibodies in the patient's blood that recognize their own tissues, known as "autoimmune" antibodies. Investigators also want to find out how likely it is that their tumor will shrink.

Conditions
Melanoma
Being tested
Sylatron, Yervoy
Keywords
unresectable, stage 3, stage 4, autoimmune, antibodies
Medical subject headings
Melanoma

What participants receive

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

  • SylatronDrug

    Also called PEG-Intron

    Sylatron - Once per week for 12 weeks, given as an injection under the skin.

  • YervoyDrug

    Also called Ipilimumab

    Yervoy - Once every 3 weeks for 12 weeks (4 times total), given over a 90-minute intravenous infusion (through the vein).

Study groups in NCT01496807
Study groupRoleWhat they receive
Yervoy with SylatronExperimentalParticipants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
Receives: Drug: Sylatron; Drug: Yervoy

What is being measured

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

  1. Maximum Tolerated Dose (MTD) of Sylatron

    MTD of peginterferon alfa-2b (Sylatron) combined with Ipilimumab (Yervoy).

    Measured: Up to 48 Months

  2. Maximum Tolerated Dose (MTD) of Ipilimumab

    MTD of Ipilimumab (Yervoy) combined with peginterferon alfa-2b (Sylatron). To assess the safety, toxicities and tolerability of a regimen of 3 μg/kg weekly Sylatron with concurrent induction Yervoy at 3 mg/kg, then if well tolerated, at 10 mg/kg every three weeks four times, in participants with unresectable stages IIIC/IV melanoma, and to define a well tolerated dose of Yervoy in that combination.

    Measured: Up to 48 Months

Secondary outcomes (4)

  1. Number of Participants With Overall Response (OR)

    Overall Response: Complete Response (CR) + Partial Response (PR) by immune-related response criteria (irRC). Immune Related CR (irCR): Complete disappearance of all lesions (whether measurable or not, and no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented. Immure Related PR (irPR): decrease in tumor burden >50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later.

    Measured: Up to 54 Months

  2. Progression Free Survival (PFS)

    Immune Related Progressive Disease (irPD): increase in tumor burden >25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later.

    Measured: Up to 54 Months

  3. Overall Survival (OS)

    OS: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

    Measured: Up to 54 Months

  4. Treatment Related Adverse Events (AEs) - Grade 3 to 5

    Percentage of participants with treatment related AEs, Grade 3 to 5. All adverse events, regardless of causality are also reported in the Serious Adverse Event/Other Adverse Event reporting area.

    Measured: 4 Years, 1 Month

Timeline

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

  1. First posted21 Dec 2011 (estimated)
  2. Study start17 Feb 2012
  3. Primary completion16 Mar 2016
  4. Study completion29 Aug 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01496807
Sponsor's protocol ID
MCC-16755
Status last verified
Jan 2017
First submitted
19 Dec 2011
Last updated
28 Apr 2017
Data monitoring committee
Yes

Publications

  • Brohl AS, Khushalani NI, Eroglu Z, Markowitz J, Thapa R, Chen YA, Kudchadkar R, Weber JS. A phase IB study of ipilimumab with peginterferon alfa-2b in patients with unresectable melanoma. J Immunother Cancer. 2016 Dec 20;4:85. doi: 10.1186/s40425-016-0194-1. eCollection 2016.

    PubMed 28031816

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sylatron and Yervoy in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site 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 7 inclusion and 18 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 28 Apr 2017. 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 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?

Yes. Results are posted in the registry (first posted 28 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Tolerated Dose (MTD) of Sylatron (time frame: Up to 48 Months). 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 NCT01496807, 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 28 Apr 2017.

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