Status:
WITHDRAWN
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
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 de...
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04495010
Start Date
March 31 2021
End Date
October 23 2027
Last Update
March 19 2021
Active Locations (118)
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1
Local Institution
Gilbert, Arizona, United States, 85234
2
Local Institution
Tucson, Arizona, United States, 85724
3
Local Institution
San Francisco, California, United States, 94158
4
Local Institution
Aurora, Colorado, United States, 80045