Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants (CheckMate 7UA)
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ClinicalTrials.gov Identifier: NCT04495010 |
Recruitment Status :
Withdrawn
(Business objectives have changed)
First Posted : July 31, 2020
Last Update Posted : March 19, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Biological: Nivolumab Biological: Ipilimumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized Study of Neoadjuvant Nivolumab Plus Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab Plus Ipilimumab Followed by Either Adjuvant Nivolumab or Postsurgical Observation Depending on Pathologic Response Compared With Adjuvant Nivolumab in Treatment-Naive Patients With Resectable Clinically Detectable Stage III Melanoma |
Estimated Study Start Date : | March 31, 2021 |
Estimated Primary Completion Date : | February 28, 2024 |
Estimated Study Completion Date : | October 23, 2027 |

Arm | Intervention/treatment |
---|---|
Experimental: Neoadjuvant treatment + Adjuvant treatment |
Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo Biological: Ipilimumab Specified dose on specified days
Other Name: Yervoy |
Experimental: Adjuvant treatment |
Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo |
Experimental: Neo treat with patho response-driven Adju treat or observation
Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
|
Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo Biological: Ipilimumab Specified dose on specified days
Other Name: Yervoy |
- Event-free survival (EFS) [ Time Frame: Up to 4 years ]
- Recurrence-free survival (RFS) Time from Surgery [ Time Frame: Up to 5 years ]
- RFS Time from Adjuvant Therapy [ Time Frame: Up to 5 years ]
- Pathologic response rate (pRR) by immune-related pathologic response (irPR) [ Time Frame: Up to 5 years ]
- Concordance major pathologic response (MPR) by local and central pathology Review [ Time Frame: Up to 5 years ]MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR
- RFS by MPR [ Time Frame: Up to 5 years ]
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
- Incidence of deaths [ Time Frame: Up to 5 years ]
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 5 years ]
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 5 years ]
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 5 years ]
- Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS) [ Time Frame: Up to 5 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Males and females, ≥ 12 years of age [Except: where local regulations and/or institutional policies do not allow for participants < 18 years of age (adolescent population) to participate. For those sites, the eligible participant population is 18 years of age or local age of majority, inclusive]
- Diagnosed with cytologically or histologically confirmed Stage IIIB, IIIC, or IIID cutaneous melanoma as per American Joint Committee on Cancer (AJCC) staging system, with ≥ 1 clinically detectable lymph node metastases (N1b, N2b, N3b), which are measurable according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
- Adult participants and adolescents 16 to 18 years old must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1. Adolescents < 16 years old must have Lanksky Play-Performance Status scale performance of ≥ 60
- Must be treatment-naïve (ie, no prior systemic anticancer therapy as adjuvant therapy for melanoma or unresectable/metastatic melanoma)
- Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Exclusion Criteria:
- Women who are breastfeeding
- Patients with serious or uncontrolled medical disorders
- Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol-defined inclusion/exclusion criteria apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495010

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT04495010 |
Other Study ID Numbers: |
CA209-7UA 2020-000070-16 ( EudraCT Number ) |
First Posted: | July 31, 2020 Key Record Dates |
Last Update Posted: | March 19, 2021 |
Last Verified: | March 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Nivolumab Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |