Description:
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.
Title
- Brief Title: 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
- 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
Clinical Trial IDs
- ORG STUDY ID:
CA209-7UA
- SECONDARY ID:
2020-000070-16
- NCT ID:
NCT04495010
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo | Adjuvant treatment |
Ipilimumab | Yervoy | Neo treat with patho response-driven Adju treat or observation |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Neoadjuvant treatment + Adjuvant treatment | Experimental | | |
Adjuvant treatment | Experimental | | |
Neo treat with patho response-driven Adju treat or observation | Experimental | Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 12 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Event-free survival (EFS) |
Time Frame: | Up to 4 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Recurrence-free survival (RFS) Time from Surgery |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | RFS Time from Adjuvant Therapy |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Pathologic response rate (pRR) by immune-related pathologic response (irPR) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Concordance major pathologic response (MPR) by local and central pathology Review |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR |
Measure: | RFS by MPR |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of Serious Adverse Events (SAEs) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of deaths |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of clinically significant changes in clinical laboratory results: Hematology tests |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Withdrawn |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
March 19, 2021