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

Withdrawn before enrolling · Phase 2

Conditions studied: Melanoma

In brief

The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.

Key facts

Study ID: NCT04495010
Run by: Bristol-Myers Squibb
People needed: 0
Starts: 2021-03-31
Expected to finish: 2027-10-23
Last updated by the study team: 2021-03-19

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Local Institution — Tucson, Arizona, United States
Local Institution — San Francisco, California, United States
Local Institution — Aurora, Colorado, United States
Local Institution — Tampa, Florida, United States
Local Institution — Atlanta, Georgia, United States
Local Institution — Atlanta, Georgia, United States
Local Institution — Marietta, Georgia, United States
Local Institution — Annapolis, Maryland, United States
Local Institution — Boston, Massachusetts, United States
Local Institution — Boston, Massachusetts, United States
Local Institution — Minneapolis, Minnesota, United States
Local Institution — Minneapolis, Minnesota, United States
Local Institution — Hattiesburg, Mississippi, United States
Local Institution — St Louis, Missouri, United States
Local Institution — Morristown, New Jersey, United States
Local Institution — New Brunswick, New Jersey, United States
Local Institution — Cleveland, Ohio, United States
Local Institution — Portland, Oregon, United States
Local Institution — Houston, Texas, United States
Local Institution — Salt Lake City, Utah, United States
Local Institution — Charlottesville, Virginia, United States
Local Institution — Seattle, Washington, United States
Local Institution — North Sydney, New South Wales, Australia
Local Institution — Westmead, New South Wales, Australia
Local Institution — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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