Trial Title:
A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
NCT ID:
NCT06101134
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Nivolumab
Relatlimab
Conditions: Keywords:
Patient preference
Nivolumab Relatlimab IV
Nivolumab Relatimab SC
Melanoma
rHuPH20
FDC IV
FDC SC
Adjuvant
Metastatic
Switch
Nivolumab
Relatlimab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
relatlimab+nivolumab
Description:
Specified dose on specified days
Arm group label:
Cohort 1: Metastatic Melanoma
Other name:
BMS-986213
Other name:
Opdualag
Intervention type:
Drug
Intervention name:
relatlimab+nivolumab+rHuPH20
Description:
Specified dose on specified days
Arm group label:
Cohort 1: Metastatic Melanoma
Intervention type:
Drug
Intervention name:
nivolumab
Description:
Specified dose on specified days
Arm group label:
Cohort 2: Resected Melanoma
Other name:
BMS-936558
Other name:
Opdivo
Intervention type:
Drug
Intervention name:
nivolumab+rHuPH20
Description:
Specified dose on specified days
Arm group label:
Cohort 2: Resected Melanoma
Other name:
BMS-986298
Summary:
The purpose of this study is to assess the patient's preference for nivolumab
subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide
patient experience data by route of administration. This study will also generate safety
data which will further characterize the safety profile of patients switching the route
of administration from intravenous (IV) to SC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Must have either metastatic melanoma and have not had previous treatment for their
cancer, or resected melanoma and have had the cancer removed fully with surgery no
later than 12 weeks before the start of treatment and confirmed free of disease
- Must have a low level of disability and cancer that is considered advanced for
metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for
resected melanoma
Exclusion Criteria:
- Must not have any brain cancer/disease treated with radiation, any cancer in the
eyes or mucous membranes (cells that cover inside surface of parts of the body and
keep it moist), any autoimmune disease, or any condition that is being treated with
steroids for inflammation (corticosteroids) or medication to decrease the body's
immune system response (immunosuppressive drugs)
Other protocol-defined inclusion/exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Local Institution - 0007
Address:
City:
Anchorage
Zip:
99508-2974
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Mayo Clinic Hospital - Phoenix
Address:
City:
Phoenix
Zip:
85054-4502
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mahesh Seetharam, Site 0013
Phone:
602-277-4868
Facility:
Name:
Local Institution - 0010
Address:
City:
San Francisco
Zip:
94115-3010
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0034
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0032
Address:
City:
Edgewood
Zip:
41017
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0028
Address:
City:
Albuquerque
Zip:
87106
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Icahn School of Medicine at Mount Sinai (ISMMS) - The Derald H. Ruttenberg Treatment Center
Address:
City:
New York
Zip:
10029-6542
Country:
United States
Status:
Withdrawn
Facility:
Name:
Swedish Medical Center - Swedish Cancer Institute (SCI) - Edmonds
Address:
City:
Edmonds
Zip:
98026-8032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly Paulson, Site 0037
Phone:
425-673-8300
Facility:
Name:
Swedish Medical Center - Swedish Cancer Institute (SCI) - Issaquah Campus
Address:
City:
Issaquah
Zip:
98026
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly Paulson, Site 0036
Phone:
425-673-8300
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly Paulson, Site 0030
Phone:
425-673-8300
Facility:
Name:
Local Institution - 0024
Address:
City:
Cipolletti
Zip:
8324
Country:
Argentina
Status:
Withdrawn
Facility:
Name:
Local Institution - 0002
Address:
City:
Viedma
Zip:
R8500JYJ
Country:
Argentina
Status:
Withdrawn
Facility:
Name:
Local Institution - 0001
Address:
City:
Rosario
Zip:
2000
Country:
Argentina
Status:
Withdrawn
Facility:
Name:
Local Institution - 0015
Address:
City:
Las Condes
Zip:
8331010
Country:
Chile
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0005
Address:
City:
Concepcion
Zip:
4070196
Country:
Chile
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0016
Address:
City:
Las Condes
Zip:
7550000
Country:
Chile
Status:
Withdrawn
Facility:
Name:
Bioclinic of Thessaloniki
Address:
City:
Thessaloniki
Zip:
546 22
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Ioannis Boukovinas, Site 0019
Phone:
306944189715
Facility:
Name:
"General Hospital of Athens ""Laiko"""
Address:
City:
Athens
Zip:
115 27
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Helen Gogas, Site 0014
Phone:
00306944681159
Facility:
Name:
Local Institution - 0031
Address:
City:
Kifisia
Zip:
145 64
Country:
Greece
Status:
Withdrawn
Facility:
Name:
Athens Medical Center
Address:
City:
Marousi
Zip:
151 25
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Apostolos Laskarakis, Site 0029
Phone:
+302104809625
Facility:
Name:
Metropolitan General Hospital
Address:
City:
Holargos, Athens
Zip:
155 62
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Theofanis Floros, Site 0023
Phone:
+302106502542
Facility:
Name:
Metropolitan Hospital, Department of Oncology
Address:
City:
Peiraias
Zip:
185 47
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Dimitrios Bafaloukos, Site 0008
Phone:
306944534944
Facility:
Name:
Aristotle University of Thessaloniki (AUTH) - Papageorgiou General Hospital
Address:
City:
Thessaloniki
Zip:
564 29
Country:
Greece
Status:
Recruiting
Contact:
Last name:
George Lazaridis, Site 0033
Phone:
302310994634
Facility:
Name:
ASST Papa Giovanni XXIII
Address:
City:
Bergamo
Zip:
24127
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Barbara Merelli, Site 0017
Phone:
390352673694
Facility:
Name:
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Laura Ridolfi, Site 0035
Phone:
390543739274
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milan
Zip:
20141
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Paola Queirolo, Site 0018
Phone:
+39 02 94372.754
Facility:
Name:
Istituto Oncologico Veneto - IRCCS
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Jacopo Pigozzo, Site 0012
Phone:
390498215609
Facility:
Name:
Istituto Nazionale Tumori Regina Elena
Address:
City:
Roma
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Virginia Ferraresi, Site 0021
Phone:
+390652666773
Facility:
Name:
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Pietro Quaglino, Site 0004
Phone:
0116335858
Facility:
Name:
AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Teresa Troiani, Site 0026
Phone:
+397462061
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Andres Barba Joaquin, Site 0011
Phone:
34935565651
Facility:
Name:
Institut Catala d'Oncologia Hospitalet
Address:
City:
Barcelona
Zip:
08908
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Juan J. Martin Liberal, Site 0022
Phone:
+34932746085
Facility:
Name:
Hospital Universitario Virgen Arrixaca
Address:
City:
Cartagena
Zip:
30120
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Pablo Cerezuela Fuentes, Site 0009
Phone:
+34968506666
Facility:
Name:
Hospital Universitari Germans Trias i Pujol
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jose Luis Manzano Mozo, Site 0020
Phone:
+34934978925 00-000-
Facility:
Name:
Hospital Universitario Marqués de Valdecilla
Address:
City:
Cantabria
Zip:
39008
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Almudena Garcia Castaño, Site 0027
Phone:
+34942202655
Facility:
Name:
Hospital San Pedro de Alcantara
Address:
City:
San Pedro Alcantara, Malaga
Zip:
10002
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Pablo Ayala de Miguel, Site 0003
Phone:
+34927181360
Facility:
Name:
Hospital Universitario Virgen del Rocío
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Pilar Sancho Marquez, Site 0006
Phone:
+34955013068
Start date:
November 6, 2023
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06101134
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06101134.html
