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MelanomaPhase 2NCT03528408

Study of Adjuvant Ipilimumab and Nivolumab in Subjects With High-risk Ocular Melanoma

A Phase 2 study testing Nivolumab and Ipilimumab in people with Melanoma and Ocular Melanoma, run by Suthee Rapisuwon at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma, as defined in eligibility criteria, without evidence of metastatic disease. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Melanoma, Ocular Melanoma
What is being tested?
Nivolumab and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
6 sitesUnited States
Study dates
26 Jul 2018to Jun 2023
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • Age ≥ 18 years at the time of consent. No dosing or adverse event data are currently available on the use of ipilimumab in combination with nivolumab in patients < 18 years of age.
  • ECOG Performance Status of 0-1 within 28 days prior to registration.
  • Patients must have clinically confirmed ocular melanoma diagnosed by a retinal specialist or ocular oncologist. NOTE: Patients with cutaneous melanoma, acral melanoma, mucosal melanoma, or conjunctival melanoma are ineligible.
  • Patients must have ocular melanoma that is considered high-risk for recurrence as defined by one of the following criteria:
  • Gene Expression Profile using 15-gene panel (Castle Bioscience) and be classified as Class 2, or
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  • 3-year recurrent risk of more than 50% as defined by Impact Genetics, or
  • Monosomy of chromosome 3 with apical tumor height > 8mm (53).
  • The primary tumor measured at least 12mm in largest basal diameter as clinically determined by the site investigator. Size is based on clinical assessment (e.g. by ultrasound or direct ophthalmoscopy) prior to enucleation or radiation therapy.
  • Archival tumor tissue is required for subjects that have had enucleation; subjects that have had enucleation but do not have available archival tissue are not eligible for participation. Archival tissue is required if available for subjects that have not had enucleation; if not available these patients are still eligible.
  • Patients must have undergone an adequate treatment for the primary ocular melanoma deemed appropriate by the treating physician.
  • All participants must have been adequately treated for local disease and have documentation of distant/metastatic disease-free status by a complete physical examination and imaging studies within 4 weeks prior to registration. Imaging studies must include CT or MRI scans of the chest, abdomen, and pelvis. Brain MRI should be performed only as clinically indicated.
  • Patients must be registered within 180 days of the last treatment performed to render the patient free of disease.
  • Patient may have received prior radiation therapy to the primary site, including after the surgical resection. No systemic radiation for metastatic ocular melanoma is permitted.
  • Subject re-enrollment: This study permits the re-enrollment of a participant who has discontinued the study as a screen failure. If re-enrolled, the participant must be re-consented
  • Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 28 days prior to registration.
  • Absolute Neutrophil Count (ANC) ≥ 1,500 cells/mm3
  • Platelets ≥ 100,000 cells/mm3
  • Hemoglobin (Hgb) ≥ 9 g/dL (NOTE: The use of transfusion or to achieve Hgb ≥ 10 g/dl is acceptable)
  • Serum creatinine ≤ 1.5 x institutional upper limit normal (IULN) OR eGFR > 30mL/min for participant with creatinine levels > 1.5 x ULN
  • Bilirubin ≤ 1.5 x IULN (except subjects with Gilbert Syndrome who can have total bilirubin ≥ 3.0 mg/dL)
  • Aspartate aminotransferase (AST) ≤ 3.0 x IULN
  • Alanine aminotransferase (ALT) ≤ 3.0 x IULN
  • Alkaline phosphatase ≤ 2.5 IULN
  • Neuropathy (sensory and motor) Grade ≤ 1 (CTCAE v4)
  • Females of childbearing potential must have a negative urine or serum pregnancy test at screening and within 24 hours prior to initiation of study treatment. Females must be willing to use contraception as outlined in the protocol. Male contraception is not required.
  • As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
  • Subject re-enrollment: This study permits the re-enrollment of a participant who has discontinued the study as a screen failure. If re-enrolled, the participant must be re-consented.

Who cannot join

  • Patients with evidence of distant metastases (stage IV ocular melanoma) are not eligible.
  • Patients with local or orbital recurrence are not eligible.
  • Patients with cutaneous, mucosal, acral or conjunctival melanoma are not eligible.
  • Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment or conditions not expected to recur in the absences of an external trigger are permitted to enroll.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks of study drug administration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Participants with previous malignancies are excluded unless a complete remission was achieved at 12 months prior to study entry and no additional therapy is required or anticipated to be required during the study period (exceptions include but are not limited to, non-melanoma skin cancers; in situ bladder cancer, in situ gastric cancer, or in situ colon cancer; in situ cervical cancer/dysplasia; or breast carcinoma in situ).
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  • History of Grade ≥ 3 allergy to human monoclonal antibodies.
  • Subjects who have had prior immunotherapy, including but not limited to interferon alfa-2b, PEG-IFN, anti-PD-1, anti-PD-L1, anti-CTLA4 intra-tumoral or vaccine therapies are not permitted to enroll.
  • Psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the participant before registration in the trial.
  • Subjects who are receiving any other investigational agents.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring systemic therapy), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Note: Testing for HIV must be performed at sites where mandated locally.
  • Subjects who are unable or unwilling to discontinue use of prohibited medications.
  • Subject is a prisoner
  • Subjects that have undergone a solid organ or stem cell transplant.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Northwestern Univeristy Feinberg School of Medicine

    Chicago, Illinois, 60611

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Columbia University

    New York, New York, 10032

  • University of California San Francisco

    San Francisco, California, 94158

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Georgetown University

    Washington D.C., District of Columbia, 20057

Other trials in United States

About this study

Official title: Phase II Single-arm Multi-center Study of Adjuvant Ipilimumab in Combination With Nivolumab in Subjects With High-risk Ocular Melanoma

This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma, as defined in eligibility criteria, without evidence of metastatic disease. All patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, patient request to discontinue or completion of treatment. Subjects may receive up to 25 doses of nivolumab and 8 doses of ipilimumab

Being tested
Nivolumab, Ipilimumab
Medical subject headings
Melanoma, Uveal Melanoma

What participants receive

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

  • NivolumabDrug

    Also called Opdivo

    Nivolumab 240 mg IV over 30 minutes given Day 1, 15 and 29 of each Cycle

  • IpilimumabDrug

    Also called Yervoy

    Ipilimumab 1 mg/kg IV over 60 minutes given Day 1 of each Cycle

Study groups in NCT03528408
Study groupRoleWhat they receive
Nivolumab and IpilimumabExperimentalAll patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks.
Receives: Drug: Nivolumab; Drug: Ipilimumab

What is being measured

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

  1. 3 year Relapse Free Survival (RFS)

    RFS is defined as time from registration to recurrence of disease or death from any cause.

    Measured: 36 months

Secondary outcomes (4)

  1. Median RFS

    RFS is defined as time from registration to recurrence of disease or death from any cause

    Measured: 12 months

  2. Overall Survival (OS)

    OS is defined as the time from registration until death from any cause

    Measured: 12 months

  3. 3 year OS

    OS is defined as the time from registration until death from any cause

    Measured: 36 months

  4. Assess Adverse Events

    Grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4

    Measured: 36 months

Timeline

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

  1. First posted17 May 2018
  2. Study start26 Jul 2018
  3. Primary completionMay 2023 (estimated)
  4. Study completionJun 2023 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03528408
Sponsor's protocol ID
HCRN-MEL17-309
Status last verified
Apr 2023
First submitted
7 May 2018
Last updated
11 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Ipilimumab in people with Melanoma and Ocular Melanoma, run by Suthee Rapisuwon at 6 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 28 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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?

Results are not available in the source record.

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?

3 year Relapse Free Survival (RFS) (time frame: 36 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 NCT03528408.

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 Apr 2023.

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