Malignant Melanoma Stage IIPhase 3NivoMelaNCT04309409
Adjuvant Nivolumab Treatment in Stage II (IIA, IIB, IIC) High-risk Melanoma
A Phase 3 study testing Nivolumab in people with Malignant Melanoma Stage II, run by University Hospital, Essen at 20 sites in Germany.
Trial summary
Stage II patients with primary surgical treatment of cuMM are often at risk for recurrence of their disease. This risk may be reduced by adjuvant systemic treatment. Due to toxicities of adjuvant therapies the aim is to identify patients at high risk for relapse and to administer adjuvant treatment only to these… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Melanoma Stage II
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 20 sitesGermany
- Study dates
- 1 Jul 2020to Jan 2028
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of stage II (AJCCv8) melanoma arising from a primary cutaneous site after surgery therapy
- Sentinel node biopsy (SNB) without detection of melanoma deposits
- Randomization not later than 12 weeks after SNB procedure
- Tumor tissue from primary tumor must be provided for biomarker analyses. In order to be randomized, a subject must be classified by MelaGenix risk analysis.
- Men and women at the age of 18 to 80 years
- Signed written, informed consent
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- Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
- Minimum life expectancy of five years excluding their melanoma diagnosis
- ECOG performance status of 0-1
- Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization:
- White blood cells (WBC) ≥ 2000/μL
- Neutrophils ≥ 1500/μL
- Platelets ≥ 100 x103/μL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤ 1.5xUL
- Creatinine clearance (CrCl) ≥ 40mL/min (using the Cockcroft-Gault formula)
- AST / ALT ≤ 3 x ULN
- Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who may have total bilirubin < 3.0 mg/dL)
- Negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) for women of childbearing potential (WOCBP) within 72 hours prior to registration.
- Women will be considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or being post-menopausal for at least 24 months or being amenorrheic for > 12 months and follicle-stimulating hormone (FSH) levels ≥ 40 IU/L.
- WOCBP and male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to CTFG during the course of this study and for at least 5 months after last dose of study medication (in Arm A only).
Who cannot join
- History of primary uveal or mucosal melanoma
- No access to sufficient tumor tissue of primary tumor
- SNB procedure > 12 weeks before randomization
- Prior active malignancy within the previous 3 years except for locally curable cancers that have been apparently cured, such as: basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix, or breast. Exception: Participants with a history of non-ulcerated cutaneous/acral primary melanoma <1 mm in depth with no nodal involvement are allowed in this trial.
- Prior or planned therapy with Interferon alpha, CTLA4 or PD-1 / PD L1 antibodies
- Use of any investigational or non-registered product (drug or vaccine) other than the study treatment
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- Administration of live vaccines within 4 weeks before start of study therapy
- Any immunosuppressive therapy given within the past 30 days
- Active psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures
- Active immune deficiencies or significant autoimmune disease
- Serious cardiac, gastrointestinal, hepatic or pulmonary disease which would reduce life expectancy to less than five years
- Serious intercurrent illness, requiring hospitalization
- Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders
- The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other active chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
- Hypersensitivity to the active substance or to any of the excipients
- Participation in another clinical study within the 30 days before registration
- For female patients: Pregnancy or breast-feeding
- For WOCBP and male patients with partners of childbearing potential: Refusal or inability to use effective means of contraception
- Lack of availability for clinical follow-up assessments
- Legal incapacity or limited legal capacity
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Germany20 sites
Universitätsklinikum Augsburg, Campus Süd
Augsburg, 86179
St. Josef-Hospital - Dermatologische Studienambulanz
Bochum, 44791
Klinikum Dortmund gGmbH - Dermatologie
Dortmund, 44137
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden - Klinik und Poliklinik für Dermatologie
Dresden, 01307
HELIOS Klinikum Erfurt
Erfurt, 99089
University Hospital Essen, Department of Dermatology, Skin Cancer Center
Essen, 45122
Universitätsklinikum Freiburg - Klinik für Dermatologie und Venerologie
Freiburg im Breisgau, 79106
Universitätsklinikum Gießen und Marburg GmbH - Klinik für Dermatologie und Allergologie
Giessen, 35392
Universitätsklinikum Hamburg-Eppendorf - Hauttumorzentrum
Hamburg, 20246
Universitätsklinikum Schleswig-Holstein, Campus Kiel - Dermatologie
Kiel, 24105
Universitätsklinikum Leipzig - Klinik u. Poliklinik f. Dermatologie, Venerologie u. Allergologie
Leipzig, 04103
Universitätsklinikum Mannheim - Klinik f. Dermatologie, Venerologie u. Allergologie
Mannheim, 68167
Klinikum der Universität München - Klinik und Poliklinik für Dermatologie und Allergologie
München, 80337
Universitätsklinikum Münster - Zentrale Studienkoordination für innovative Dermatologie (ZID)
Münster, 48149
Fachklinik Hornheide - Internistische Onkologie
Münster, 48157
Klinikum Nürnberg Nord - Hautklinik
Nuremberg, 90419
Harzklinikum Dorothea Christiane Erxleben - Klinik für Dermatologie & Allergologie
Quedlinburg, 06484
Universitätsmedizin Rostock -Klinik und Poliklinik für Dermatologie und Venerologie
Rostock, Mecklenburg-Vorpommern, 18057
Universitätsklinikum Tübingen - Dermatoonkologie
Tübingen, 72076
Universitätsklinikum Würzburg - Klinik für Dermatologie, Venerologie und Allergologie
Würzburg, Bavaria, 97080
About this study
Official title: Adjuvant Nivolumab Treatment in Stage II High-risk Melanoma - A Randomized, Controlled, Phase III Trial With Biomarker-based Risk Stratification
Stage II patients with primary surgical treatment of cuMM are often at risk for recurrence of their disease. This risk may be reduced by adjuvant systemic treatment. Due to toxicities of adjuvant therapies the aim is to identify patients at high risk for relapse and to administer adjuvant treatment only to these patients. Thus an optimal balance between insufficient treatment vs. overtreatment has to be found.
To define these patients a prognostic biomarker test will be used in addition to conventional AJCC staging. AJCC staging takes into account several prognostic factors. However, to subdivide stage II melanoma patients into having a low or high risk for relapse further methods are needed.
This clinical trial will evaluate whether adjuvant nivolumab treatment will improve relapse-free survival (RFS) in patients with stage II high-risk melanoma as compared to observation only. The randomized approach of this trial offers the most objective method with the least influence of bias. Since patients with stage II melanoma are usually not receiving adjuvant treatment, no patient will be undertreated in case of randomization into observational arm.
Read the detailed description
The NivoMela trial is a randomized, controlled, prospective, multi-center national phase III trial with biomarker-based risk stratification.
Stage II melanoma patients having undergone surgery of the malignant melanoma will be screened using the MelaGenix GEP score to identify patients at high risk for relapse. It is expected, that 61% of screened patients will belong to this group.
Patients with a risk score of > 0.0 (HR 1.48, 1.11-1.98) corresponding to high risk of relapse will be randomized at a ratio of 2:1 to receive either nivolumab as adjuvant treatment (arm A) or observation only (arm B).
Stratification factors for randomization are:
- Tumor stage: IIA versus IIB versus IIC
- Gender: Female versus Male
- Site of primary tumor: extremities versus trunk versus head \&neck
All screened patients with a risk score of ≤ 0.0 who are not eligible for randomization will be followed for RFS, DMFS and OS for at least 5 years according to German Follow-up guidelines (Arm C).
Various factors that could potentially predict clinical response and incidence of AEs to treatment with nivolumab will be investigated in peripheral blood and tumor specimen taken at baseline. Data from these investigations will be evaluated for associations with clinical efficacy (eg, ORR, PFS, OS) and safety/toxicity (AE). The samples may also be used for exploratory analyses to assess biomarkers associated with melanoma and/or with immunotherapy treatment.
- Conditions
- Malignant Melanoma Stage II
- Being tested
- Nivolumab
- Keywords
- Stage II malignant melanoma, patients having undergone surgery, IIA melanoma, IIB melanoma, IIC melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
480 mg nivolumab fixed dose given as 60-minute iv infusion every 4 weeks for 12 doses over 1 year
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab (Arm A) | Experimental | Patients with a risk score of > 0.0 corresponding to high risk of relapse (randomized):
Nivolumab will be applied at a flat dose of 480 mg given as 60-minute iv infusion every 4 weeks for 12 doses over 1 year. Afterwards these patients will receive intense clinical follow up according German Follow up guidelines. Receives: Drug: Nivolumab |
| Observation, High Risk (Arm B) | No intervention | Patients with a risk score of > 0.0 corresponding to high risk of relapse (randomized): Control group (observation only). These patients will receive intense clinical follow up but no further specific therapy according German Follow up guidelines. |
| Observation, Low Risk (Arm C) | No intervention | Patients with a risk score of ≤ 0.0 corresponding to low risk of relapse who are not eligible for randomization: These patients will receive intense clinical follow up but no further specific therapy according German Follow up guidelines. Documentation of clinical outcome of these patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival (RFS) rates
Determination of efficacy of nivolumab in a biomarker-selected high-risk-enriched stage II melanoma patient population in comparison to control receiving observation only in a 2 (Arm A=nivolumab) : 1 (Arm B=observation) randomization, as measured by Relapse-Free Survival (RFS) rates at 36 and 60 months.
RFS is defined as the time from date of registration until documented tumor progression date or date of death of any cause, whichever occurs first in all patients tested with the MelaGenix gene expression profiling (GEP).
Measured: 5 years
Secondary outcomes (5)
Distant metastasis-free survival (DMFS) rates
DMFS rates at 36 and 60 months
Measured: 5 years
Melanoma-specific survival (MSS) rates
MSS rates at 36 and 60 months
Measured: 5 years
Overall survival (OS) rates
OS rates at 36 and 60 months
Measured: 5 years
Adverse events ≥ Grade 3 according to CTCAE Version 5.0 criteria (Safety / Toxicity)
All adverse events ≥ Grade 3 according to CTCAE Version 5.0 criteria, that are definitely, probably, or possibly related to the administration of the investigational agent
Measured: Arm A: Until 100 days after discontinuation of dosing of the investigational product; Arm B: Until 1 year after patient´s written consent
Clinical utility/decision impact of the MelaGenix Gene Expression Profiling (GEP) Score in stratifying patients for adjuvant therapy
Patients with a risk score of > 0.0 (HR 1.48, 1.11-1.98) will be classified as high risk for relapse. It is expected, that 61% of screened patients will belong to this group.
Patients with a risk score of score of ≤ 0.0 will be classified as low risk for relapse.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Jul 2020
- Primary completionSep 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Melanoma Stage IIStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with a risk score of \> 0.0 (HR 1.48, 1.11-1.98) corresponding to high risk of relapse will be randomized at a ratio of 2:1 to receive either nivolumab as adjuvant treatment (arm A) or observation only (arm B). All screened patients with a risk score of ≤ 0.0 who are not eligible for randomization will be followed for RFS, DMFS and OS for at least 5 years according to German Follow-up guidelines (Arm C).
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Dirk Schadendorf, University Hospital, Essen
- Investigators
- Dirk Schadendorf, Prof. Dr., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309409
- Sponsor's protocol ID
- CA209-7DL
- Acronym
- NivoMela
- Status last verified
- May 2024
- First submitted
- 12 Mar 2020
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Nivolumab Treatment in Stage II High-risk Melanoma - A Randomized, Controlled, Phase III Trial With Biomarker-based Risk Stratification
- ClinicalTrials.gov ID
- NCT04309409
- Acronym / sponsor ID
- NivoMela / CA209-7DL
- Conditions
- Malignant Melanoma Stage II
- Keywords
- Stage II malignant melanoma, patients having undergone surgery, IIA melanoma, IIB melanoma, IIC melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Mar 2020 (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.
Stage II patients with primary surgical treatment of cuMM are often at risk for recurrence of their disease. This risk may be reduced by adjuvant systemic treatment. Due to toxicities of adjuvant therapies the aim is to identify patients at high risk for relapse and to administer adjuvant treatment only to these patients. Thus an optimal balance between insufficient treatment vs. overtreatment has to be found.
To define these patients a prognostic biomarker test will be used in addition to conventional AJCC staging. AJCC staging takes into account several prognostic factors. However, to subdivide stage II melanoma patients into having a low or high risk for relapse further methods are needed.
This clinical trial will evaluate whether adjuvant nivolumab treatment will improve relapse-free survival (RFS) in patients with stage II high-risk melanoma as compared to observation only. The randomized approach of this trial offers the most objective method with the least influence of bias. Since patients with stage II melanoma are usually not receiving adjuvant treatment, no patient will be undertreated in case of randomization into observational arm.
Detailed description
The NivoMela trial is a randomized, controlled, prospective, multi-center national phase III trial with biomarker-based risk stratification.
Stage II melanoma patients having undergone surgery of the malignant melanoma will be screened using the MelaGenix GEP score to identify patients at high risk for relapse. It is expected, that 61% of screened patients will belong to this group.
Patients with a risk score of > 0.0 (HR 1.48, 1.11-1.98) corresponding to high risk of relapse will be randomized at a ratio of 2:1 to receive either nivolumab as adjuvant treatment (arm A) or observation only (arm B).
Stratification factors for randomization are:
- Tumor stage: IIA versus IIB versus IIC
- Gender: Female versus Male
- Site of primary tumor: extremities versus trunk versus head \&neck
All screened patients with a risk score of ≤ 0.0 who are not eligible for randomization will be followed for RFS, DMFS and OS for at least 5 years according to German Follow-up guidelines (Arm C).
Various factors that could potentially predict clinical response and incidence of AEs to treatment with nivolumab will be investigated in peripheral blood and tumor specimen taken at baseline. Data from these investigations will be evaluated for associations with clinical efficacy (eg, ORR, PFS, OS) and safety/toxicity (AE). The samples may also be used for exploratory analyses to assess biomarkers associated with melanoma and/or with immunotherapy treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients with a risk score of > 0.0 (HR 1.48, 1.11-1.98) corresponding to high risk of relapse will be randomized at a ratio of 2:1 to receive either nivolumab as adjuvant treatment (arm A) or observation only (arm B). All screened patients with a risk score of ≤ 0.0 who are not eligible for randomization will be followed for RFS, DMFS and OS for at least 5 years according to German Follow-up guidelines (Arm C).
| Arm | Type | Receives |
|---|---|---|
| Nivolumab (Arm A) | Experimental | Drug: NivolumabPatients with a risk score of > 0.0 corresponding to high risk of relapse (randomized): Nivolumab will be applied at a flat dose of 480 mg given as 60-minute iv infusion every 4 weeks for 12 doses over 1 year. Afterwards these patients will receive intense clinical follow up according German Follow up guidelines. |
| Observation, High Risk (Arm B) | No intervention | –Patients with a risk score of > 0.0 corresponding to high risk of relapse (randomized): Control group (observation only). These patients will receive intense clinical follow up but no further specific therapy according German Follow up guidelines. |
| Observation, Low Risk (Arm C) | No intervention | –Patients with a risk score of ≤ 0.0 corresponding to low risk of relapse who are not eligible for randomization: These patients will receive intense clinical follow up but no further specific therapy according German Follow up guidelines. Documentation of clinical outcome of these patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically confirmed diagnosis of stage II (AJCCv8) melanoma arising from a primary cutaneous site after surgery therapy
- Sentinel node biopsy (SNB) without detection of melanoma deposits
- Randomization not later than 12 weeks after SNB procedure
- Tumor tissue from primary tumor must be provided for biomarker analyses. In order to be randomized, a subject must be classified by MelaGenix risk analysis.
- Men and women at the age of 18 to 80 years
Key exclusion criteria (21 listed)
- History of primary uveal or mucosal melanoma
- No access to sufficient tumor tissue of primary tumor
- SNB procedure > 12 weeks before randomization
- Prior active malignancy within the previous 3 years except for locally curable cancers that have been apparently cured, such as: basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix, or breast. Exception: Participants with a history of non-ulcerated cutaneous/acral primary melanoma <1 mm in depth with no nodal involvement are allowed in this trial.
- Prior or planned therapy with Interferon alpha, CTLA4 or PD-1 / PD L1 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 |
|---|---|---|
| NivolumabAlso: Opdivo480 mg nivolumab fixed dose given as 60-minute iv infusion every 4 weeks for 12 doses over 1 year | Drug | Nivolumab (Arm A) |
Primary outcome
Relapse-Free Survival (RFS) rates
Time frame: 5 years
Determination of efficacy of nivolumab in a biomarker-selected high-risk-enriched stage II melanoma patient population in comparison to control receiving observation only in a 2 (Arm A=nivolumab) : 1 (Arm B=observation) randomization, as measured by Relapse-Free Survival (RFS) rates at 36 and 60 months. RFS is defined as the time from date of registration until documented tumor progression date or date of death of any cause, whichever occurs first in all patients tested with the MelaGenix gene expression profiling (GEP).
5 secondary outcomes
Distant metastasis-free survival (DMFS) rates
Time frame: 5 years
Melanoma-specific survival (MSS) rates
Time frame: 5 years
Overall survival (OS) rates
Time frame: 5 years
Adverse events ≥ Grade 3 according to CTCAE Version 5.0 criteria (Safety / Toxicity)
Time frame: Arm A: Until 100 days after discontinuation of dosing of the investigational product; Arm B: Until 1 year after patient´s written consent
Clinical utility/decision impact of the MelaGenix Gene Expression Profiling (GEP) Score in stratifying patients for adjuvant therapy
Time frame: 5 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 23 May 2024.
- Individual participant dataSharing planned: No
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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.
Dirk Schadendorf, Prof. Dr. principal investigator
University Hospital, Essen
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab in people with Malignant Melanoma Stage II, run by University Hospital, Essen at 20 sites in Germany.
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 21 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 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Relapse-Free Survival (RFS) rates (time frame: 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 23 May 2024.