A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors

NCT01928394 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CA209-0322013-002844-10
• Study Type: interventional
• Target: 1,163
• Locations: 8 countries
• Sites: 38

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.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate ( ORR )

  The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.

  60 months

Study Arms (6)

Arm N - Nivolumab

EXPERIMENTAL

Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Biological: Nivolumab

Arm N-I, Level 1: Nivolumab+Ipilimumab

EXPERIMENTAL

Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 1 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Biological: Nivolumab; Biological: Ipilimumab

Arm N-I, Level 2: Nivolumab+Ipilimumab

EXPERIMENTAL

Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Biological: Nivolumab; Biological: Ipilimumab

Arm N-I, Level 2b: Nivolumab+Ipilimumab

EXPERIMENTAL

Nivolumab 3 mg/kg solution intravenously plus Ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Biological: Nivolumab; Biological: Ipilimumab

Arm N-I, Level 2c: Nivolumab+Ipilimumab

EXPERIMENTAL

Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Biological: Nivolumab; Biological: Ipilimumab

Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib

EXPERIMENTAL

Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Biological: Nivolumab; Biological: Ipilimumab; Drug: Cobimetinib

Interventions

Nivolumab BIOLOGICAL

Also known as: BMS-936558, MDX-1106

Arm N - Nivolumab; Arm N-I, Level 1: Nivolumab+Ipilimumab; Arm N-I, Level 2: Nivolumab+Ipilimumab; Arm N-I, Level 2b: Nivolumab+Ipilimumab; Arm N-I, Level 2c: Nivolumab+Ipilimumab; Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib

Ipilimumab BIOLOGICAL

Also known as: Yervoy, BMS-734016, MDX-010

Arm N-I, Level 1: Nivolumab+Ipilimumab; Arm N-I, Level 2: Nivolumab+Ipilimumab; Arm N-I, Level 2b: Nivolumab+Ipilimumab; Arm N-I, Level 2c: Nivolumab+Ipilimumab; Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib

Cobimetinib DRUG

Also known as: Cotellic

Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (38)

Local Institution - 0047

Muscle Shoals, Alabama, 35661, United States

Location

Local Institution - 0044

Aurora, Colorado, 80045, United States

Location

Local Institution - 0015

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0046

Gainesville, Florida, 32610, United States

Location

Local Institution - 0021

Tampa, Florida, 33612, United States

Location

Local Institution - 0001

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0004

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0005

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0043

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0049

Omaha, Nebraska, 68130, United States

Location

Local Institution - 0045

Mineola, New York, 11501, United States

Location

Local Institution - 0006

New York, New York, 10065, United States

Location

Local Institution - 0003

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0008

Durham, North Carolina, 27710, United States

Location

Local Institution - 0007

Portland, Oregon, 97239, United States

Location

Local Institution - 0011

Franklin, Tennessee, 37067, United States

Location

Local Institution - 0002

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0009

Houston, Texas, 77030, United States

Location

Local Institution - 0042

Seattle, Washington, 98104, United States

Location

Local Institution - 0038

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0039

Copenhagen, 2100, Denmark

Location

Local Institution - 0014

Helsinki, Uusimaa, 00290, Finland

Location

Local Institution - 0036

Tampere, 33521, Finland

Location

Local Institution - 0048

Bonn, 53105, Germany

Location

Local Institution - 0026

Frankfurt, 60488, Germany

Location

Local Institution - 0016

Heidelberg, 69120, Germany

Location

Local Institution - 0050

Kassel, 34125, Germany

Location

Local Institution - 0024

Bologna, 40138, Italy

Location

Local Institution - 0019

Milan, 20133, Italy

Location

Local Institution - 0020

Napoli, 80131, Italy

Location

Local Institution - 0032

Padua, 35128, Italy

Location

Local Institution - 0037

Barcelona, 08036, Spain

Location

Local Institution - 0023

Madrid, 28040, Spain

Location

Local Institution - 0017

Madrid, 28041, Spain

Location

Local Institution - 0010

Madrid, 28050, Spain

Location

Local Institution - 0018

London, Greater London, SW3 6JJ, United Kingdom

Location

Local Institution - 0012

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Location

Local Institution - 0013

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 31100038 DERIVED

• 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.

  PMID: 30110194 DERIVED

• 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.

  PMID: 29489427 DERIVED

• 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.

  PMID: 27733243 DERIVED

• 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.

  PMID: 27269741 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Nivolumab; Ipilimumab; cobimetinib

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 23, 2013
• Study Start: October 24, 2013
• Primary Completion: February 5, 2019
• Study Completion: November 18, 2024
• Last Updated: December 27, 2024
• Results First Posted: March 24, 2020

Record last verified: 2024-12

Locations

ES (4); DE (4); IT (4); CA (1); US (19); FI (2); DK (1); GB (3)