NCT01928394 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2024-12-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate ( ORR )

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
intervention Names
Biological: Nivolumab
label
Arm N - Nivolumab
type
EXPERIMENTAL
description
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
intervention Names
Biological: Nivolumab
Biological: Ipilimumab
label
Arm N-I, Level 1: Nivolumab+Ipilimumab
type
EXPERIMENTAL
description
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
intervention Names
Biological: Nivolumab
Biological: Ipilimumab
label
Arm N-I, Level 2: Nivolumab+Ipilimumab
type
EXPERIMENTAL
description
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
intervention Names
Biological: Nivolumab
Biological: Ipilimumab
label
Arm N-I, Level 2b: Nivolumab+Ipilimumab
type
EXPERIMENTAL
description
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
intervention Names
Biological: Nivolumab
Biological: Ipilimumab
label
Arm N-I, Level 2c: Nivolumab+Ipilimumab
type
EXPERIMENTAL
description
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
intervention Names
Biological: Nivolumab
Biological: Ipilimumab
Drug: Cobimetinib
label
Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib
type
EXPERIMENTAL

interventions

arm Group Labels
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
name
Nivolumab
other Names
BMS-936558
MDX-1106
type
BIOLOGICAL
arm Group Labels
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
name
Ipilimumab
other Names
Yervoy
BMS-734016
MDX-010
type
BIOLOGICAL
arm Group Labels
Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib
name
Cobimetinib
other Names
Cotellic
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 1163
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Objective Response Rate ( ORR )
time Frame
60 months

Full study description

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

Source references

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.
pmid
31100038
type
DERIVED
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.
pmid
30110194
type
DERIVED
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.
pmid
29489427
type
DERIVED
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.
pmid
27733243
type
DERIVED
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.
pmid
27269741
type
DERIVED