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NCT04495010 Clinical Trial

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

Melanoma Clinical Trial

— CheckMate 7UA  

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Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04495010
Other study ID # CA209-7UA
Secondary ID 2020-000070-16
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date March 31, 2021
Est. completion date October 23, 2027

Study information
Verified date March 2021
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 23, 2027
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Nivolumab
Specified dose on specified days
• Ipilimumab
Specified dose on specified days

Locations
Country Name City State
Australia Local Institution Adelaide South Australia
Australia Local Institution Ballarat Victoria
Australia Local Institution Doubleview Western Australia
Australia Local Institution Greenslopes Queensland
Australia Local Institution Hobart Tasmania
Australia Local Institution Melbourne Victoria
Australia Local Institution Melbourne Victoria
Australia Local Institution Nedlands Western Australia
Australia Local Institution North Sydney New South Wales
Australia Local Institution Westmead New South Wales
Australia Local Institution Woolloongabba Queensland
Austria Local Institution Graz
Austria Local Institution Innsbruck
Austria Local Institution Salzburg
Austria Local Institution St. Poelten
Austria Local Institution Wien
Belgium Local Institution Brussels
Belgium Local Institution Gent
Belgium Local Institution Wilrijk
Brazil Local Institution Brasilia Distrito Federal
Brazil Local Institution Curitiba Parana
Brazil Local Institution Florianopolis Santa Catarina
Brazil Local Institution Fortaleza Ceara
Brazil Local Institution Porto Alegre RIO Grande DO SUL
Brazil Local Institution Porto Alegre RIO Grande DO SUL
Brazil Local Institution Porto Alegre RIO Grande DO SUL
Brazil Local Institution Rio De Janeiro
Brazil Local Institution Sao Jose do Rio Preto SAO Paulo
Brazil Local Institution Sao Paulo
Brazil Local Institution Sao Paulo
Denmark Local Institution Aarhus
Denmark Local Institution Herlev
Denmark Local Institution Odense C
France Local Institution Bordeaux
France Local Institution Dijon
France Local Institution Lille
France Local Institution Marseille
France Local Institution Nantes
France Local Institution Nice
France Local Institution Paris
France Local Institution Pierre-Benite
France Local Institution Rennes
France Local Institution Sr Priest En Jarez
France Local Institution Toulouse
France Local Institution Villejuif
Germany Local Institution Berlin
Germany Local Institution Erlangen
Germany Local Institution Essen
Germany Local Institution Hannover
Germany Local Institution Heidelberg
Germany Local Institution Kiel
Germany Local Institution Luebeck
Germany Local Institution Mainz
Germany Local Institution Regensburg
Germany Local Institution Tuebingen
Germany Local Institution Wuerzburg
Italy Local Institution Bergamo
Italy Local Institution Meldola
Italy Local Institution Napoli
Italy Local Institution Novara
Italy Local Institution Padova
Italy Local Institution Pavia
Netherlands Local Institution Amsterdam
Netherlands Local Institution Amsterdam
Netherlands Local Institution Breda
Netherlands Local Institution Geleen
Netherlands Local Institution Leiden
Netherlands Local Institution Rotterdam
Netherlands Local Institution Utrecht
Poland Local Institution Krakow
Poland Local Institution Warszawa
Poland Local Institution Wroclaw
Russian Federation Local Institution Krasnodar
Russian Federation Local Institution Ryazan
Russian Federation Local Institution Saint Petersburg
Russian Federation Local Institution Saint-Petersburg
Spain Local Institution Barcelona
Spain Local Institution Haddon Heights
Spain Local Institution Madrid
Spain Local Institution Malaga
Spain Local Institution Oviedo
Spain Local Institution Santiago de Compostela
Spain Local Institution Sevilla
Sweden Local Institution Vaxjo
Switzerland Local Institution Zuerich
United Kingdom Local Institution Cambridge
United Kingdom Local Institution Glasgow
United Kingdom Local Institution Guildford
United Kingdom Local Institution Leeds
United Kingdom Local Institution London
United Kingdom Local Institution London
United Kingdom Local Institution Manchester
United Kingdom Local Institution Northwood
United Kingdom Local Institution Oxford
United Kingdom Local Institution Sutton
United States Local Institution Annapolis Maryland
United States Local Institution Atlanta Georgia
United States Local Institution Atlanta Georgia
United States Local Institution Aurora Colorado
United States Local Institution Boston Massachusetts
United States Local Institution Boston Massachusetts
United States Local Institution Charlottesville Virginia
United States Local Institution Cleveland Ohio
United States Local Institution Gilbert Arizona
United States Local Institution Hattiesburg Mississippi
United States Local Institution Houston Texas
United States Local Institution Marietta Georgia
United States Local Institution Minneapolis Minnesota
United States Local Institution Minneapolis Minnesota
United States Local Institution Morristown New Jersey
United States Local Institution New Brunswick New Jersey
United States Local Institution Portland Oregon
United States Local Institution Saint Louis Missouri
United States Local Institution Salt Lake City Utah
United States Local Institution San Francisco California
United States Local Institution Seattle Washington
United States Local Institution Tampa Florida
United States Local Institution Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Denmark,  France,  Germany,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Event-free survival (EFS) Up to 4 years
Secondary Recurrence-free survival (RFS) Time from Surgery Up to 5 years
Secondary RFS Time from Adjuvant Therapy Up to 5 years
Secondary Pathologic response rate (pRR) by immune-related pathologic response (irPR) Up to 5 years
Secondary Concordance major pathologic response (MPR) by local and central pathology Review MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR Up to 5 years
Secondary RFS by MPR Up to 5 years
Secondary Incidence of Adverse Events (AEs) Up to 5 years
Secondary Incidence of Serious Adverse Events (SAEs) Up to 5 years
Secondary Incidence of deaths Up to 5 years
Secondary Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to 5 years
Secondary Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Up to 5 years
Secondary Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to 5 years
Secondary Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS) Up to 5 years
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