MelanomaPhase 2NCT03758729
Phase II Study of Nivolumab in Combination With Radiation Therapy as Definitive Treatment for Patients With Locally Advanced, Unresectable Head and Neck Mucosal Melanoma.
A Phase 2 study testing Nivolumab and Radiation Therapy in people with Melanoma, run by Samsung Medical Center.
Trial summary
This is a Phase 2, single center study to evaluate the efficacy, safety of nivolumab in combination with radiation therapy in patients with mucosal melanoma of the head and neck (MMHN). Target Accrual and Study duration We will accrue up to 26 patients. It is estimated to take up to 2 years. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Nivolumab and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2020to 11 May 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years
- Histologically or cytologically confirmed mucosal melanoma of head and neck
- Locally advanced and unresectable
- No previous chemotherapy for purpose of palliation
- ECOG performance status of 0~2
- Measurable lesion per RECIST 1.1 criteria
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- Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status. Repeat samples may be required if adequate tissue is not provided. Newly obtained endoscopic biopsy specimens are preferred to archived samples and formalin-fixed, paraffin-embedded (FFPE) block specimens are preferred to slides.
- Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
- Collection of an archived tissue sample will also be requested (where available) to support evaluation of the clinical utility of biomarker assessment in newly obtained vs. archived tissue samples; however, a subject will not be precluded from participating in the study if an archived tissue sample is not available for collection or is otherwise insufficient for analysis.
- Adequate marrow, hepatic, renal and cardiac functions:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin ≤ 1.5 x ULN Absolute neutrophil count (ANC) ≥ 1,500/uL Platelets ≥ 100,000/uL Hemoglobin ≥ 8.0 g/dL Serum creatinine OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl) Serum creatinine ≤1.5 X upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
- Creatinine clearance should be calculated per institutional standard.
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 8.7.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- provision of a signed written informed consent
Who cannot join
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Active or history of autoimmune disease or immune deficiency, including MG, myositis, hepatitis, SLE, RA, IBD or GBS)
- Severe co-morbid illness and/or active infections
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has a known history of active TB (Bacillus Tuberculosis)
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- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
- Pregnant or lactating women
- History of documented congestive heart failure; angina pectoris requiring medication; evidence of tranasmural myocardial infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; or high risk of uncontrollable arrhythmia
- Active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
- Must not have undergone a major surgical procedure < 4 weeks or radiotherapy <2 weeks prior to D1 of treatment
- Administration of a live, attenuated vaccine within 4 weeks before study treatment
- Treatment with systemic immunosuppressive medication (including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 2 weeks prior to D1 of treatment
About this study
This is a Phase 2, single center study to evaluate the efficacy, safety of nivolumab in combination with radiation therapy in patients with mucosal melanoma of the head and neck (MMHN). Target Accrual and Study duration We will accrue up to 26 patients. It is estimated to take up to 2 years. The sample size is calculated by use of SWOG CRAB (Cancer Research And Biostatistics) to control the type I error at 5 % for null hypothesis that the true response rate was 25 % or below and to have 80 % of power if the true response rate was 50 % or higher. Although the target number of evaluable patients is 23, we planned to recruit 10% more than the target number of patients considering dropout, total 26.
Read the detailed description
This is a phase II, single-arm, single-center study to evaluate the response rate, efficacy and safety of nivolumab in combination with radiation therapy in subjects with of locally advanced, unresectable head and neck mucosal melanoma.
A cycle is defined as 14 days. The nivolumab dose will be fixed at the recommended phase II dose of 3mg/kg as a 60-minute IV infusion every two weeks. Patients will continue on nivolumab up to 8 weeks, until disease progression, unacceptable toxicity, investigator's decision to remove patient from the study, patient refusal to continue, or alternative treatment.
Concurrent radiotherapy of 70Gy for 6-7 weeks will be initiated on the same day of first nivolumab dose of cycle 1.
The combination of 70 Gy radiotherapy for 6-7 weeks begins on the day of initial administration of nivolumab, radiation therapy dose and treatment schedule 2.0, based on NCFC practice.
Nivolumab is administered every two weeks in in combination with radiation therapy and has elapsed since 8 weeks (after 4 cycles) The administration of clinical trials in is terminated but nivolumabs is sustainable at the discretion of investigator. (This is carried out independently of the clinical trial) The response rate of radiation therapy is assessed by performing a tumor assessment every two months up to the end of radiation therapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Nivolumab 3mg/kg + NS 100mL MIV over 1hr every 2 weeks
Radiation TherapyRadiation
Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | Nivolumab 3mg/kg + NS 100mL MIV over 1hr every 2 weeks Receives: Drug: Nivolumab; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
RR, as determied by irRECIST criteria, is defined as the proportion of all subjects whose best overall response (BOR) is either a CR or PR. BOR is determined by the best response designation recorded between the date of treatment initiation and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever is the first. For subjects without documented progression or subsequent anti-cancer therapy, all available repsonse designations will contribute to the BOR determination.
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 posted29 Nov 2018
- Study startMay 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completion11 May 2020
Why it stopped: Internal Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758729
- Sponsor's protocol ID
- 2018-04-093
- Status last verified
- Feb 2021
- First submitted
- 28 Nov 2018
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Nivolumab in Combination With Radiation Therapy as Definitive Treatment for Patients With Locally Advanced, Unresectable Head and Neck Mucosal Melanoma.
- ClinicalTrials.gov ID
- NCT03758729
- Acronym / sponsor ID
- 2018-04-093
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal Issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- 11 May 2020 (actual)
- First posted
- 29 Nov 2018 (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 Phase 2, single center study to evaluate the efficacy, safety of nivolumab in combination with radiation therapy in patients with mucosal melanoma of the head and neck (MMHN). Target Accrual and Study duration We will accrue up to 26 patients. It is estimated to take up to 2 years. The sample size is calculated by use of SWOG CRAB (Cancer Research And Biostatistics) to control the type I error at 5 % for null hypothesis that the true response rate was 25 % or below and to have 80 % of power if the true response rate was 50 % or higher. Although the target number of evaluable patients is 23, we planned to recruit 10% more than the target number of patients considering dropout, total 26.
Detailed description
This is a phase II, single-arm, single-center study to evaluate the response rate, efficacy and safety of nivolumab in combination with radiation therapy in subjects with of locally advanced, unresectable head and neck mucosal melanoma.
A cycle is defined as 14 days. The nivolumab dose will be fixed at the recommended phase II dose of 3mg/kg as a 60-minute IV infusion every two weeks. Patients will continue on nivolumab up to 8 weeks, until disease progression, unacceptable toxicity, investigator's decision to remove patient from the study, patient refusal to continue, or alternative treatment.
Concurrent radiotherapy of 70Gy for 6-7 weeks will be initiated on the same day of first nivolumab dose of cycle 1.
The combination of 70 Gy radiotherapy for 6-7 weeks begins on the day of initial administration of nivolumab, radiation therapy dose and treatment schedule 2.0, based on NCFC practice.
Nivolumab is administered every two weeks in in combination with radiation therapy and has elapsed since 8 weeks (after 4 cycles) The administration of clinical trials in is terminated but nivolumabs is sustainable at the discretion of investigator. (This is carried out independently of the clinical trial) The response rate of radiation therapy is assessed by performing a tumor assessment every two months up to the end of radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Drug: Nivolumab, Radiation: Radiation TherapyNivolumab 3mg/kg + NS 100mL MIV over 1hr every 2 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 19 years
- Histologically or cytologically confirmed mucosal melanoma of head and neck
- Locally advanced and unresectable
- No previous chemotherapy for purpose of palliation
- ECOG performance status of 0~2
Key exclusion criteria (13 listed)
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Active or history of autoimmune disease or immune deficiency, including MG, myositis, hepatitis, SLE, RA, IBD or GBS)
- Severe co-morbid illness and/or active infections
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
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 |
|---|---|---|
| NivolumabNivolumab 3mg/kg + NS 100mL MIV over 1hr every 2 weeks | Drug | Nivolumab |
| Radiation TherapyRadiation Therapy | Radiation | Nivolumab |
Primary outcome
Response rate
Time frame: 2 years
RR, as determied by irRECIST criteria, is defined as the proportion of all subjects whose best overall response (BOR) is either a CR or PR. BOR is determined by the best response designation recorded between the date of treatment initiation and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever is the first. For subjects without documented progression or subsequent anti-cancer therapy, all available repsonse designations will contribute to the BOR determination.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Radiation Therapy in people with Melanoma, run by Samsung Medical Center.
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 16 inclusion and 13 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: withdrawn, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Response rate (time frame: 2 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 16 Feb 2021.