Trial Title:
A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
NCT ID:
NCT05625412
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Docetaxel
Capecitabine
Nivolumab
Conditions: Keywords:
Solid tumors
Nivolumab
Chemotherapy
BMS-986360
CC-90001
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BMS-986360
Description:
Specified dose on specified days
Arm group label:
BMS-986360
Arm group label:
BMS-986360 + Capecitabine
Arm group label:
BMS-986360 + Docetaxel
Arm group label:
BMS-986360 + Nivolumab
Other name:
CC-90001
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Specified dose on specified days
Arm group label:
BMS-986360 + Docetaxel
Other name:
Taxotere®
Intervention type:
Drug
Intervention name:
Nivolumab
Description:
Specified dose on specified days
Arm group label:
BMS-986360 + Nivolumab
Other name:
Opdivo®
Other name:
BMS-936558
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Specified dose on specified days
Arm group label:
BMS-986360 + Capecitabine
Other name:
Xeloda®
Summary:
The aim of this study is to assess the safety and tolerability of BMS-986360 as
monotherapy and in combination with chemotherapy or nivolumab in participants with
advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants in Part 1 must have histologic or cytologic confirmation of non-small
cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous
cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal
cell carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), or
sarcoma, that is advanced (metastatic, recurrent, and/or unresectable) with
measurable disease per RECIST v1.1. In Part 2, only participants with histologic
confirmation of advanced NSCLC or mTNBC with measurable disease per RECIST v1.1 are
eligible.
- In Part 2, archival biopsy collected within 3 months of screening with no
intervening therapy (formalin-fixed, paraffin embedded [FFPE] blocks or a minimum of
20 freshly cut unstained FFPE slides with an associated pathological report) or
fresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1
(C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional at
progression. Therefore, the participant in Part 2 must have a suitable tumor lesion
for the biopsy procedure, as judged by the investigator, in order to be eligible for
the study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants resistant/refractory to or intolerant of existing standard therapies
known to provide clinical benefit (in addition, participants with NSCLC must be
resistant or refractory to anti-PD-(L)1-based immunotherapy)
Exclusion Criteria:
- Participants with primary central nervous system (CNS) disease, or tumors with CNS
metastases as the only disease site, will be excluded. Participants with controlled
brain metastases, however, will be allowed to enroll. Controlled brain metastases
are defined as no radiographic progression for at least 4 weeks following radiation
and/or surgical treatment (or 4 weeks of observation if no intervention is
clinically indicated), no longer taking steroids for at least 2 weeks prior to first
dose of study intervention, and with no new or progressive neurological signs and
symptoms.
- Participants with a condition requiring systemic treatment with corticosteroids (>
10 mg daily prednisone equivalent) within 14 days or other immunosuppressive
medications within 30 days of randomization. Inhaled or topical steroids and adrenal
replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the
absence of active autoimmune disease.
- Participants with concurrent malignancy or history of prior malignancy active within
2 years (except history of early-stage basal/squamous cell skin cancer or
non-invasive or in situ cancers who have undergone definitive treatment) are
excluded unless treatment was completed at least 2 years before randomization and
the participant has no evidence of disease.
- Participants with NSCLC with known or not tested for epidermal growth factor
receptor (EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E
mutations, or anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1)
translocations sensitive to available targeted inhibitor therapy
Other protocol-defined inclusion/exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Angeles Clinic and Research Institute - West Los Angeles Office
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Status:
Recruiting
Contact:
Last name:
Omid Hamid, Site 0029
Phone:
310-231-2121
Facility:
Name:
Local Institution - 0019
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Withdrawn
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Berz, Site 0051
Facility:
Name:
Local Institution - 0067
Address:
City:
Honolulu
Zip:
96813
Country:
United States
Status:
Withdrawn
Facility:
Name:
Ochsner Clinic Foundation
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniel Johnson, Site 0026
Phone:
504-842-3910
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Martin Gutierrez, Site 0001
Phone:
551-996-5863
Facility:
Name:
Local Institution - 0018
Address:
City:
Huntersville
Zip:
28078
Country:
United States
Status:
Completed
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melissa Johnson, Site 0028
Phone:
615-329-7274
Facility:
Name:
South Texas Accelerated Research Therapeutics (START)
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Drew Rasco, Site 0027
Phone:
210-593-5250
Facility:
Name:
START Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin Call, Site 0046
Phone:
801-907-4750
Facility:
Name:
Hospital Británico de Buenos Aires
Address:
City:
Ciudad autónoma de Buenos Aires
Zip:
1280
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Karina Vera, Site 0033
Phone:
1121571056
Facility:
Name:
Local Institution - 0032
Address:
City:
ABB
Zip:
C1199ABB
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Site 0032
Facility:
Name:
Clinica Adventista Belgrano
Address:
City:
Caba
Zip:
C1430EGF
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Aldo Perfetti, Site 0030
Phone:
5491132682903
Facility:
Name:
Instituto Alexander Fleming
Address:
City:
Ciudad Autónoma de Buenos Aires
Zip:
1426
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Florencia Tsou, Site 0031
Phone:
5411322189001189
Facility:
Name:
St Vincent's Hospital - The Kinghorn Cancer Center
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jia Liu, Site 0010
Phone:
0405536859
Facility:
Name:
GenesisCare North Shore
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Nick Pavlakis, Site 0061
Phone:
61294631172
Facility:
Name:
Gallipoli Medical Research Ltd
Address:
City:
Brisbane
Zip:
4120
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Kenneth O'Byrne, Site 0008
Phone:
0731766505
Facility:
Name:
Frankston Hospital
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jacqui Thomson, Site 0063
Phone:
61397856344
Facility:
Name:
The Ottawa Hospital - General Campus
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
John Hilton, Site 0003
Phone:
(613)737-7700
Facility:
Name:
Local Institution - 0005
Address:
City:
Toronto
Zip:
M5G1Z5
Country:
Canada
Status:
Completed
Facility:
Name:
FALP
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Christian Caglevic, Site 0047
Phone:
56224457254
Facility:
Name:
Pontificia Universidad Catolica de Chile
Address:
City:
Santiago
Zip:
8330032
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Cesar Sanchez, Site 0035
Phone:
56223546919
Facility:
Name:
Bradfordhill
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Carlos Rojas Garcia, Site 0034
Phone:
+56998744662
Facility:
Name:
Institut Paoli-Calmettes
Address:
City:
Marseille
Zip:
13273
Country:
France
Status:
Recruiting
Contact:
Last name:
Cecile Vicier, Site 0049
Phone:
33491223670
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Contact:
Last name:
Cristina Smolenschi, Site 0052
Phone:
33142114211
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75248
Country:
France
Status:
Recruiting
Contact:
Last name:
Marie-Paule Sablin, Site 0048
Phone:
+33144324675
Facility:
Name:
Institut Claudius Regaud
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Florence Dalenc, Site 0050
Phone:
33531155122
Facility:
Name:
Humanitas
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Armando Santoro, Site 0057
Phone:
390282244080
Facility:
Name:
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Vanesa Gregorc, Site 0059
Phone:
390119933250
Facility:
Name:
Istituto Oncologico Veneto IRCCS
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Valentina Guarneri, Site 0065
Phone:
00390498215931
Facility:
Name:
Local Institution - 0038
Address:
City:
Mexico City
Zip:
03100
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 0038
Facility:
Name:
Local Institution - 0041
Address:
City:
Zapopan
Zip:
45070
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 0041
Facility:
Name:
Local Institution - 0039
Address:
City:
Monterrey
Zip:
66460
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 0039
Facility:
Name:
Local Institution - 0037
Address:
City:
Puebla
Zip:
72424
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 0037
Facility:
Name:
Hospital Clínic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ivan Manuel Victoria Ruiz, Site 0053
Phone:
34932274208
Facility:
Name:
Hospital Universitario Ramón y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Federico Longo Muñoz, Site 0055
Phone:
34913368263
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jon Zugazagoitia Fraile, Site 0056
Phone:
913908714
Facility:
Name:
Hospital Universitario Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Reyes Bernabe Caro, Site 0064
Phone:
34955015273
Start date:
December 9, 2022
Completion date:
July 30, 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/NCT05625412
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT05625412.html
