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Efficacy Study of Nivolumab Compared to Placebo in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIB/C Melanoma (CheckMate 76K)
EU CTIS ID: 2022-502354-14-00
What this study is testing
To compare the efficacy, as measured by recurrence free survival (RFS), provided by nivolumab monotherapy versus placebo in participants with completely resected stage IIB/C melanoma with no evidence of disease
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must have been diagnosed with stage IIB/C cutaneous melanoma (AJCC Staging, 8th edition) and have histologically confirmed melanoma that is completely surgically resected with documented negative margins (per local standard) for disease on resected specimens. All melanomas, except ocular and mucosal melanoma, regardless of primary site of disease will be allowed.
- Complete resection must be performed within 12 weeks prior to randomization. Note: In case of delays exceeding 12 weeks due to unforeseen circumstances, the eligibility should be discussed with the Medical Monitor or designee. Participants must have had a negative sentinel lymph node biopsy. Participants in whom a sentinel lymph node biopsy procedure could not be done or a sentinel lymph node was not detected are not eligible.
- Participants must have disease-free status documented by a complete physical examination (within 14 days) and imaging studies within 4 weeks (28 days) prior to randomization. Imaging studies must include CT scans of the chest/abdomen/pelvis or CT scan of the chest and MRI scans of the abdomen and pelvis, and all known sites of resected disease (lymph nodes ≥ 15 mm in short axis). Participants with signs and symptoms consistent with brain metastases should have imaging studies done to rule out the presence of brain metastases.
- Has not been previously treated for melanoma beyond complete surgical resection of the melanoma lesion.
- Has recovered adequately from toxicity and/or complications from surgery prior to study start.
- ECOG performance status of 0 or 1 at the time of enrollment
You likely can't join if
- History of ocular and mucosal melanoma.
- Participants with active, known, or suspected autoimmune disease. Participants 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 absence of an external trigger are permitted to enroll.
- Prior malignancy active 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.
- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Women who are pregnant or breastfeeding
- Participants with serious or uncontrolled medical disorders.
See the full eligibility criteria
Who can join
- Participants must have been diagnosed with stage IIB/C cutaneous melanoma (AJCC Staging, 8th edition) and have histologically confirmed melanoma that is completely surgically resected with documented negative margins (per local standard) for disease on resected specimens. All melanomas, except ocular and mucosal melanoma, regardless of primary site of disease will be allowed.
- Complete resection must be performed within 12 weeks prior to randomization. Note: In case of delays exceeding 12 weeks due to unforeseen circumstances, the eligibility should be discussed with the Medical Monitor or designee. Participants must have had a negative sentinel lymph node biopsy. Participants in whom a sentinel lymph node biopsy procedure could not be done or a sentinel lymph node was not detected are not eligible.
- Participants must have disease-free status documented by a complete physical examination (within 14 days) and imaging studies within 4 weeks (28 days) prior to randomization. Imaging studies must include CT scans of the chest/abdomen/pelvis or CT scan of the chest and MRI scans of the abdomen and pelvis, and all known sites of resected disease (lymph nodes ≥ 15 mm in short axis). Participants with signs and symptoms consistent with brain metastases should have imaging studies done to rule out the presence of brain metastases.
- Has not been previously treated for melanoma beyond complete surgical resection of the melanoma lesion.
- Has recovered adequately from toxicity and/or complications from surgery prior to study start.
- ECOG performance status of 0 or 1 at the time of enrollment
- Tumor tissue (minimum of 15 unstained slides or 1 FFPE block) from the resected site of disease must be provided to the central laboratory prior to randomization. If the required tumor tissue content cannot be provided, the eligibility should be discussed with the Medical Monitor or designee.
What rules you out
- History of ocular and mucosal melanoma.
- Participants with active, known, or suspected autoimmune disease. Participants 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 absence of an external trigger are permitted to enroll.
- Prior malignancy active 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.
- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Women who are pregnant or breastfeeding
- Participants with serious or uncontrolled medical disorders.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Australia
- Canada
- Switzerland
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Australia; Canada; Switzerland; United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.