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Metastatic Uveal MelanomaPhase 2NCT01585194

Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma

A Phase 2 study testing Ipilimumab, Laboratory Biomarker Analysis and Nivolumab in people with Metastatic Uveal Melanoma and Stage IV Uveal Melanoma AJCC v7, run by M.D. Anderson Cancer Center 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

This phase II trial studies how well nivolumab and ipilimumab work in treating patients with uveal melanoma that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ipilimumab, Laboratory Biomarker Analysis and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteUnited States
Study dates
29 Nov 2012to 14 May 2024
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to give written informed consent
  • History of uveal melanoma and documented metastatic disease with at least one measurable lesion is required; which is >= 1 cm x 1 cm (on spiral computed tomography [CT] or equivalent)
  • Any number of prior therapies is allowed
  • White blood cell (WBC) >= 2000/uL
  • Absolute neutrophil count (ANC) >= 1500/uL
  • Platelets >= 100 x 10^3/uL
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  • Hemoglobin >= 9 g/dL
  • Creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) > 40 mL/min (using the Cockcroft-Gault formula)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x ULN for patients without liver metastasis, =< 5 x ULN for liver metastases
  • Bilirubin =< 1.5 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
  • In suspected patients no active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
  • Baseline imaging in the form of CT chest, abdomen, pelvis with oral and intravenous contrast within 28 days of study entry; for patients with a contrast allergy, choice of alternative body imaging will be at the discretion of the investigator or his designee; magnetic resonance imaging (MRI) of the brain is only needed if clinically indicated
  • Prior to start of treatment must be more than 21 days elapsed from surgery, radiation therapy, or prior chemotherapy; more than 42 days elapsed from prior immune therapy including vaccines
  • Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized

Who cannot join

  • Untreated primary uveal melanoma except in cases where metastatic disease is diagnosed at the time of primary disease
  • Metastatic uveal melanoma patients with bone-only disease
  • Any other malignancy from which the patient has been disease-free for less than 2 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, breast, or prostate
  • Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]; motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis)
  • Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
  • Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
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  • Concomitant therapy with any of the following: tamoxifen, toremifene, IL 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids greater than physiologic replacement doses; ocular steroid use is acceptable; (a) concomitant palliative radiation for the purposes of symptom management is allowed
  • Women of childbearing potential (WOCBP) who: (a) are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for up to 26 weeks after cessation of study drug, or (b) have a positive pregnancy test at baseline, or (c) are pregnant or breastfeeding
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma

This phase II trial studies how well nivolumab and ipilimumab work in treating patients with uveal melanoma that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Overall response rate.

SECONDARY OBJECTIVES:

  1. Progression-free survival. II. Median overall survival. III. One-year overall survival.

EXPLORATORY OBJECTIVES:

  1. Tissue and blood correlates to define immune infiltration and signatures as a result of treatment with nivolumab plus ipilimumab.

OUTLINE:

INDUCTION PHASE: Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 60 days.

Being tested
Ipilimumab, Laboratory Biomarker Analysis, Nivolumab
Medical subject headings
Uveal Melanoma

What participants receive

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

  • IpilimumabBiological

    Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • NivolumabBiological

    Also called BMS-936558, MDX-1106, NIVO, ONO-4538

    Given IV

Study groups in NCT01585194
Study groupRoleWhat they receive
Treatment (nivolumab, ipilimumab)ExperimentalINDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Ipilimumab; Other: Laboratory Biomarker Analysis; Biological: Nivolumab

What is being measured

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

  1. Overall Response Rate, Defined Per RECIST 1.1

    RECIST 1.1 response is defined as >=30% reduction in sum of the longest diameter of target lesions

    Measured: Up to 2 years of treatment plus 60 days from last study dose

Secondary outcomes (3)

  1. Progression-Free Survival

    Time from enrollment to progressive disease or death. Progressive disease is defined per RECIST 1.1 as >=20% increase in the sum of the longest diameter of target lesions from nadir, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: From date of enrollment until the date of progressive disease or date of death from any cause, whichever came first, and assessed up to 60 days after completion of study treatment, a median of 13.0 months

  2. Overall Survival

    Measured from time of enrollment to death

    Measured: From date of enrollment until the date of death from any cause, a median of 13.0 months

  3. 1-year Overall Survival

    Measured as percentage of patients alive at 1 year from enrollment

    Measured: Baseline up to 1 year

Timeline

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

  1. First posted25 Apr 2012 (estimated)
  2. Study start29 Nov 2012
  3. Primary completion2 Dec 2019
  4. Study completion14 May 2024

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
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01585194
Sponsor's protocol ID
2011-0919
Other IDs
NCI-2015-00853, NCI-2012-00665, 2011-0919, R21CA208609
Status last verified
Jun 2024
First submitted
23 Apr 2012
Last updated
9 Jul 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Pelster MS, Gruschkus SK, Bassett R, Gombos DS, Shephard M, Posada L, Glover MS, Simien R, Diab A, Hwu P, Carter BW, Patel SP. Nivolumab and Ipilimumab in Metastatic Uveal Melanoma: Results From a Single-Arm Phase II Study. J Clin Oncol. 2021 Feb 20;39(6):599-607. doi: 10.1200/JCO.20.00605. Epub 2020 Oct 30.

    PubMed 33125309

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ipilimumab, Laboratory Biomarker Analysis and Nivolumab in people with Metastatic Uveal Melanoma and Stage IV Uveal Melanoma AJCC v7, run by M.D. Anderson Cancer Center 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 15 inclusion and 9 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 9 Jul 2024. 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 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?

Yes. Results are posted in the registry (first posted 10 Dec 2020). 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?

Overall Response Rate, Defined Per RECIST 1.1 (time frame: Up to 2 years of treatment plus 60 days from last study dose). 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 NCT01585194, 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 9 Jul 2024.

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