Clinical trial NCT01928394: A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
Official title: A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced or Metastatic Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-08-23
Enrollment: 1163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.

Detailed description: All tumor types are now closed for enrollment:

Triple Negative Breast Cancer

Gastric Cancer

Pancreatic Cancer

Small Cell Lung Cancer

Bladder Cancer

Ovarian Cancer

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects with histologically or cytologically confirmed locally advanced or metastatic disease of the following tumor types:
* Triple Negative Breast Cancer
* Gastric Cancer
* Pancreatic Cancer
* Small Cell Lung Cancer
* Bladder Cancer
* Ovarian Cancer
* Subjects must have measurable disease
* Eastern Cooperative Oncology Group (ECOG) of 0 or 1
* Adequate hematological and organ function as confirmed by laboratory values

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases
* Subjects with active, known or suspected autoimmune disease
* Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
* Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting T cell is also prohibited

Primary outcomes:
measure: Objective Response Rate ( ORR )
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Local Institution - 0047
state: Alabama
city: Aurora
country: United States
facility: Local Institution - 0044
state: Colorado
city: New Haven
country: United States
facility: Local Institution - 0015
state: Connecticut
city: Gainesville
country: United States
facility: Local Institution - 0046
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0021
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0001
state: Georgia
city: Baltimore
country: United States
facility: Local Institution - 0004
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0005
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0043
state: Massachusetts
city: Omaha
country: United States
facility: Local Institution - 0049
state: Nebraska
city: Mineola
country: United States
facility: Local Institution - 0045
state: New York
city: New York
country: United States
facility: Local Institution - 0006
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0003
state: North Carolina
city: Durham
country: United States
facility: Local Institution - 0008
state: North Carolina
city: Portland
country: United States
facility: Local Institution - 0007
state: Oregon
city: Franklin
country: United States
facility: Local Institution - 0011
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0002
state: Tennessee
city: Houston
country: United States
facility: Local Institution - 0009
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0042
state: Washington
city: Toronto
country: Canada
facility: Local Institution - 0038
state: Ontario
city: Copenhagen
country: Denmark
facility: Local Institution - 0039
city: Helsinki
country: Finland
facility: Local Institution - 0014
state: Uusimaa
city: Tampere
country: Finland
facility: Local Institution - 0036
city: Bonn
country: Germany
facility: Local Institution - 0048
city: Frankfurt
country: Germany
facility: Local Institution - 0026
city: Heidelberg
country: Germany
facility: Local Institution - 0016
city: Kassel
country: Germany
facility: Local Institution - 0050
city: Bologna
country: Italy
facility: Local Institution - 0024
city: Milano
country: Italy
facility: Local Institution - 0019
city: Napoli
country: Italy
facility: Local Institution - 0020
city: Padova
country: Italy
facility: Local Institution - 0032
city: Barcelona
country: Spain
facility: Local Institution - 0037
city: Madrid
country: Spain
facility: Local Institution - 0023
city: Madrid
country: Spain
facility: Local Institution - 0017
city: Madrid
country: Spain
facility: Local Institution - 0010
city: London
country: United Kingdom
facility: Local Institution - 0018
state: Greater London
city: Glasgow
country: United Kingdom
facility: Local Institution - 0012
state: Lanarkshire
city: Sutton
country: United Kingdom
facility: Local Institution - 0013
state: Surrey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Sharma P, Siefker-Radtke A, de Braud F, Basso U, Calvo E, Bono P, Morse MA, Ascierto PA, Lopez-Martin J, Brossart P, Rohrberg K, Mellado B, Fischer BS, Meadows-Shropshire S, Abdel Saci, Callahan MK, Rosenberg J. Nivolumab Alone and With Ipilimumab in Previously Treated Metastatic Urothelial Carcinoma: CheckMate 032 Nivolumab 1 mg/kg Plus Ipilimumab 3 mg/kg Expansion Cohort Results. J Clin Oncol. 2019 Jul 1;37(19):1608-1616. doi: 10.1200/JCO.19.00538. Epub 2019 May 17.
citation: Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, Ott PA, Peltola K, Jaeger D, Evans J, de Braud F, Chau I, Harbison CT, Dorange C, Tschaika M, Le DT. CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer. J Clin Oncol. 2018 Oct 1;36(28):2836-2844. doi: 10.1200/JCO.2017.76.6212. Epub 2018 Aug 15.
citation: Teo MY, Seier K, Ostrovnaya I, Regazzi AM, Kania BE, Moran MM, Cipolla CK, Bluth MJ, Chaim J, Al-Ahmadie H, Snyder A, Carlo MI, Solit DB, Berger MF, Funt S, Wolchok JD, Iyer G, Bajorin DF, Callahan MK, Rosenberg JE. Alterations in DNA Damage Response and Repair Genes as Potential Marker of Clinical Benefit From PD-1/PD-L1 Blockade in Advanced Urothelial Cancers. J Clin Oncol. 2018 Jun 10;36(17):1685-1694. doi: 10.1200/JCO.2017.75.7740. Epub 2018 Feb 28.
citation: Sharma P, Callahan MK, Bono P, Kim J, Spiliopoulou P, Calvo E, Pillai RN, Ott PA, de Braud F, Morse M, Le DT, Jaeger D, Chan E, Harbison C, Lin CS, Tschaika M, Azrilevich A, Rosenberg JE. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. Lancet Oncol. 2016 Nov;17(11):1590-1598. doi: 10.1016/S1470-2045(16)30496-X. Epub 2016 Oct 9.
citation: Antonia SJ, Lopez-Martin JA, Bendell J, Ott PA, Taylor M, Eder JP, Jager D, Pietanza MC, Le DT, de Braud F, Morse MA, Ascierto PA, Horn L, Amin A, Pillai RN, Evans J, Chau I, Bono P, Atmaca A, Sharma P, Harbison CT, Lin CS, Christensen O, Calvo E. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial. Lancet Oncol. 2016 Jul;17(7):883-895. doi: 10.1016/S1470-2045(16)30098-5. Epub 2016 Jun 4.