Mucosal MelanomaPhase 2NCT03241186
Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma
A Phase 2 study testing Ipilimumab and Nivolumab in people with Mucosal Melanoma, run by Robert R. McWilliams, MD at 7 sites in United States.
Trial summary
This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycles 5-15 (maximum of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucosal Melanoma
- What is being tested?
- Ipilimumab and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Sep 2017to Sep 2023
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Histological confirmation of melanoma of any mucosal site including (but not limited to) anus/rectum, vulvar/vaginal, sinonasal. NOTE: Melanomas of cutaneous origin and/or ocular origin are ineligible.
- R0 or R1 resection of primary melanoma tumor (no gross disease can be left behind, but microscopically positive margins are acceptable).
- Surgery within ≤ 90 days of registration.
- ECOG Performance Status (PS) ≤ 1
- The following laboratory values obtained ≤ 14 days prior to registration:
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- Hematological:
- Absolute Neutrophil Count (ANC) ≥ 1500/mm^3
- Hemoglobin (Hgb) ≥ 9 g/dL (may be transfused)
- Platelet (Plt) 100,000/mm^3
- Renal:
- Serum Creatinine ≤ 1.5 x ULN
- Hepatic:
- Alkaline Phosphatase (Alk Phos) ≤ 1.5 x upper limit of normal (ULN)
- Total and Direct Bilirubin ≤ 1.5 × (ULN)
- Aspartate aminotransferase (AST) ≤ 1.5 × ULN
- Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
- 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.
- Willing to return to enrolling institution for follow-up
- Willing to provide archival tissue prior to C1D1 if available and blood samples for correlative research purposes
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Immunocompromised patients and subjects known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Subjects known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
- Other active malignancy ≤ 3 years prior to registration. EXCEPTIONS: Malignancies with a very low (< 5%) risk of recurrence such as non-melanotic skin cancer or carcinoma-in-situ of the cervix.
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- History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
- Active autoimmune disease -including but not limited to:
- Subjects with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease,
- Subjects with a history of symptomatic autoimmune disease requiring systemic treatment within the past 2 years with the use of disease modifying agents, corticosteroids, or immunosuppressive drugs.
- rheumatoid arthritis
- systemic progressive sclerosis (scleroderma)
- systemic lupus erythematosus
- psoriasis
- autoimmune vasculitis (e.g., Wegener's Granulomatosis)
- CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis, multiple sclerosis)
- EXCEPTION: autoimmune conditions that are only requiring replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Any radiation within 2 weeks prior to study initiation. Neoadjuvant and adjuvant radiation are allowed, but must be completed > 2 weeks prior to registration.
- Any prior systemic therapy for melanoma (chemotherapy, immunotherapy, targeted therapy)
- Women of childbearing potential (WOCBP) must be willing to abstain from heterosexual intercourse or to use 2 forms of effective methods of contraception from the time of informed consent until 5 months after the last dose of study drug. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method. Examples include: intrauterine device (IUD), vasectomy of a female subject's male partner, contraceptive rod implanted into the skin, or use of two of the following: diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive.*Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. NOTE: Male subjects are not required to utilize contraception. The study regimen is not genotoxic and systemic concentrations sufficient to produce a risk of fetal toxicity are not expected in WOCBP partners from exposure to a male participant's seminal fluid.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Mayo Clinic- Florida
Jacksonville, Florida, 32224
University of Minnesota
Minneapolis, Minnesota, 555455455
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Providence Portland Medical Center
Portland, Oregon, 97213
Mayo Clinic Rochester
Rochester, Minnesota, 55905
About this study
Official title: Single Arm Phase II Study of Ipilimumab and Nivolumab as Adjuvant Therapy for Resected Mucosal Melanoma (SALVO Study). HCRN: MEL16-252
This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycles 5-15 (maximum of 15) or until disease recurrence or intolerance before completion of 15 cycles.
Read the detailed description
Ipilimumab and Nivolumab Combination Administration
- Ipilimumab 1mg/kg given IV Day 1 for 3 weeks (21 days), for 4 cycles
- Nivolumab 3mg/kg given IV Day 1 for 3 weeks (21 days), for 4 cycles
Nivolumab Alone Administration
- Nivolumab 480mg given IV Day 1 for 4 weeks (28 days), for 5-15 cycles
Nivolumab is to be administered as an approximately 30-minute IV infusion (± 10 minutes). At the end of the infusion, flush the line with a sufficient quantity of normal saline.
Ipilimumab is to be administered as an approximately 30-minute IV infusion (± 10 minutes). At the end of the infusion, flush the line with a sufficient quantity of normal saline or 5% dextrose solution.
When both study drugs are to be administered on the same day, separate infusion bags and filters must be used for each infusion. Nivolumab is to be administered first. The nivolumab infusion must be promptly followed by a saline flush to clear the line of nivolumab before starting the ipilimumab infusion. The second infusion will always be ipilimumab, and will start at least 30 minutes after completion of the nivolumab infusion.
The dosing calculations should be based on the body weight from Cycle 1 Day 1. If the subject's weight on the day of dosing differs by > 5% from the weight used to calculate the dose, the dose should be recalculated based on the current day of treatment weight. All doses should be rounded to the nearest milligram. There will be no dose modifications allowed.
- Conditions
- Mucosal Melanoma
- Being tested
- Ipilimumab, Nivolumab
- Keywords
- Ipilimumab, Nivolumab, OPDIVO, IgG4 kappa immunoglobulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Also called Yervoy, BMS-734016, MDX010
1mg/kg
NivolumabDrug
Also called OPDIVO, BMS-936558, ONO-4538, MDX1106
3mg/kg
NivolumabDrug
Also called OPDIVO, BMS-936558, ONO-4538, MDX1106
480mg
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV | Experimental | Cycles 1-4: Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV Day 1 of each Cycle Each Cycle = 21 days
Cycles 5-15: Nivolumab IV 480 mg Day 1 of each Cycle Each Cycle = 28 days Receives: Drug: Ipilimumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Recurrence-free survival time (RFS)
Date the patient receives the first dose of study medication to the date of documentation of first disease recurrence or death due to any cause.
Measured: 1.5 years
Secondary outcomes (2)
Assess the Adverse Events
Adverse events will be graded and attribution assigned using CTCAE version 4
Measured: 2 years
Overall Survival (OS)
The time from registration to death due to any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start12 Sep 2017
- Primary completion15 Sep 2022
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert R. McWilliams, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Hoosier Cancer Research Network
- Responsible party
- Sponsor-investigator, Robert R. McWilliams, MD, Hoosier Cancer Research Network
- Investigators
- Robert R. McWilliams, MD, Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241186
- Sponsor's protocol ID
- MEL16-252
- Status last verified
- Dec 2022
- First submitted
- 2 Aug 2017
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Phase II Study of Ipilimumab and Nivolumab as Adjuvant Therapy for Resected Mucosal Melanoma (SALVO Study). HCRN: MEL16-252
- ClinicalTrials.gov ID
- NCT03241186
- Acronym / sponsor ID
- MEL16-252
- Conditions
- Mucosal Melanoma
- Keywords
- Ipilimumab, Nivolumab, OPDIVO, IgG4 kappa immunoglobulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Robert R. McWilliams, MDUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Hoosier Cancer Research Network
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- Sep 2023 (estimated)
- First posted
- 7 Aug 2017 (actual)
- 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.
This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycles 5-15 (maximum of 15) or until disease recurrence or intolerance before completion of 15 cycles.
Detailed description
Ipilimumab and Nivolumab Combination Administration
- Ipilimumab 1mg/kg given IV Day 1 for 3 weeks (21 days), for 4 cycles
- Nivolumab 3mg/kg given IV Day 1 for 3 weeks (21 days), for 4 cycles
Nivolumab Alone Administration
- Nivolumab 480mg given IV Day 1 for 4 weeks (28 days), for 5-15 cycles
Nivolumab is to be administered as an approximately 30-minute IV infusion (± 10 minutes). At the end of the infusion, flush the line with a sufficient quantity of normal saline.
Ipilimumab is to be administered as an approximately 30-minute IV infusion (± 10 minutes). At the end of the infusion, flush the line with a sufficient quantity of normal saline or 5% dextrose solution.
When both study drugs are to be administered on the same day, separate infusion bags and filters must be used for each infusion. Nivolumab is to be administered first. The nivolumab infusion must be promptly followed by a saline flush to clear the line of nivolumab before starting the ipilimumab infusion. The second infusion will always be ipilimumab, and will start at least 30 minutes after completion of the nivolumab infusion.
The dosing calculations should be based on the body weight from Cycle 1 Day 1. If the subject's weight on the day of dosing differs by > 5% from the weight used to calculate the dose, the dose should be recalculated based on the current day of treatment weight. All doses should be rounded to the nearest milligram. There will be no dose modifications allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV | Experimental | Drug: Ipilimumab, Drug: NivolumabCycles 1-4: Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV Day 1 of each Cycle Each Cycle = 21 days Cycles 5-15: Nivolumab IV 480 mg Day 1 of each Cycle Each Cycle = 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Histological confirmation of melanoma of any mucosal site including (but not limited to) anus/rectum, vulvar/vaginal, sinonasal. NOTE: Melanomas of cutaneous origin and/or ocular origin are ineligible.
- R0 or R1 resection of primary melanoma tumor (no gross disease can be left behind, but microscopically positive margins are acceptable).
- Surgery within ≤ 90 days of registration.
- ECOG Performance Status (PS) ≤ 1
Key exclusion criteria (21 listed)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Immunocompromised patients and subjects known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Subjects known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
- Other active malignancy ≤ 3 years prior to registration. EXCEPTIONS: Malignancies with a very low (< 5%) risk of recurrence such as non-melanotic skin cancer or carcinoma-in-situ of the cervix.
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 |
|---|---|---|
| IpilimumabAlso: Yervoy, BMS-734016, MDX0101mg/kg | Drug | Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV |
| NivolumabAlso: OPDIVO, BMS-936558, ONO-4538, MDX11063mg/kg | Drug | Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV |
| NivolumabAlso: OPDIVO, BMS-936558, ONO-4538, MDX1106480mg | Drug | Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV |
Primary outcome
Assess Recurrence-free survival time (RFS)
Time frame: 1.5 years
Date the patient receives the first dose of study medication to the date of documentation of first disease recurrence or death due to any cause.
2 secondary outcomes
Assess the Adverse Events
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Robert R. McWilliams, MD study chair
Hoosier Cancer Research Network
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab and Nivolumab in people with Mucosal Melanoma, run by Robert R. McWilliams, MD at 7 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 20 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
This study is still under way. Results are not available in the source record yet.
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?
Assess Recurrence-free survival time (RFS) (time frame: 1.5 years). 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 9 Dec 2022.