Advanced or Metastatic Solid TumorsPhase 1/2NCT01928394

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

A Phase 1/2 study testing Nivolumab, Ipilimumab and Cobimetinib in people with Advanced or Metastatic Solid Tumors, run by Bristol-Myers Squibb at 38 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced or Metastatic Solid Tumors
What is being tested?: Nivolumab, Ipilimumab and Cobimetinib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,163 participants
Where: 38 sitesin 8 countries
Study dates: 24 Oct 2013to 18 Nov 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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

Trial locations and contacts

38 sites in 8 countries.

Country

City, postcode or hospital

38 sites in 8 countries

United States19 sites

Local Institution - 0001
Atlanta, Georgia, 30322
Local Institution - 0044
Aurora, Colorado, 80045
Local Institution - 0004
Baltimore, Maryland, 21287
Local Institution - 0005
Boston, Massachusetts, 02215
Local Institution - 0043
Boston, Massachusetts, 02215
Local Institution - 0003
Charlotte, North Carolina, 28204
Local Institution - 0008
Durham, North Carolina, 27710
Local Institution - 0011
Franklin, Tennessee, 37067
Local Institution - 0046
Gainesville, Florida, 32610
Local Institution - 0009
Houston, Texas, 77030
Local Institution - 0045
Mineola, New York, 11501
Local Institution - 0047
Muscle Shoals, Alabama, 35661
Local Institution - 0002
Nashville, Tennessee, 37232
Local Institution - 0015
New Haven, Connecticut, 06520
Local Institution - 0006
New York, New York, 10065
Local Institution - 0049
Omaha, Nebraska, 68130
Local Institution - 0007
Portland, Oregon, 97239
Local Institution - 0042
Seattle, Washington, 98104
Local Institution - 0021
Tampa, Florida, 33612

Other trials in United States

Germany4 sites

Local Institution - 0048
Bonn, 53105
Local Institution - 0026
Frankfurt, 60488
Local Institution - 0016
Heidelberg, 69120
Local Institution - 0050
Kassel, 34125

Other trials in Germany

Italy4 sites

Local Institution - 0024
Bologna, 40138
Local Institution - 0019
Milan, 20133
Local Institution - 0020
Naples, 80131
Local Institution - 0032
Padova, 35128

Other trials in Italy

Spain4 sites

Local Institution - 0037
Barcelona, 08036
Local Institution - 0023
Madrid, 28040
Local Institution - 0017
Madrid, 28041
Local Institution - 0010
Madrid, 28050

Other trials in Spain

United Kingdom3 sites

Local Institution - 0012
Glasgow, Lanarkshire, G12 0YN
Local Institution - 0018
London, Greater London, SW3 6JJ
Local Institution - 0013
Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Finland2 sites

Local Institution - 0014
Helsinki, Uusimaa, 00290
Local Institution - 0036
Tampere, 33521

Other trials in Finland

Canada1 site

Local Institution - 0038
Toronto, Ontario, M5G 2M9

Other trials in Canada

Denmark1 site

Local Institution - 0039
Copenhagen, 2100

Other trials in Denmark

About this study

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

Read the 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

Conditions: Advanced or Metastatic Solid Tumors
Being tested: Nivolumab, Ipilimumab, Cobimetinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NivolumabBiological
Also called BMS-936558, MDX-1106
IpilimumabBiological
Also called Yervoy, BMS-734016, MDX-010
CobimetinibDrug
Also called Cotellic

Study groups in NCT01928394
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: Nivolumab; Biological: Ipilimumab; Drug: Cobimetinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 201318 Nov 2024

First posted23 Aug 2013 (estimated)
Study start24 Oct 2013
Primary completion5 Feb 2019
Study completion18 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01928394
Sponsor's protocol ID: CA209-032
Other IDs: 2013-002844-10
Status last verified: Dec 2024
First submitted: 21 Aug 2013
Last updated: 27 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Expanded access: Available

Publications

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.
PubMed 31100038
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.
PubMed 30110194
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.
PubMed 29489427
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.
PubMed 27733243
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.
PubMed 27269741

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01928394
Acronym / sponsor ID: CA209-032
Conditions: Advanced or Metastatic Solid Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,163 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 24 Oct 2013 (actual)
Primary completion: 5 Feb 2019 (actual)
Study completion: 18 Nov 2024 (actual)
First posted: 23 Aug 2013 (estimated)
Results: Posted 24 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Arm N - Nivolumab	Experimental	Biological: NivolumabNivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Arm N-I, Level 1: Nivolumab+Ipilimumab	Experimental	Biological: Nivolumab, Biological: IpilimumabNivolumab 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
Arm N-I, Level 2: Nivolumab+Ipilimumab	Experimental	Biological: Nivolumab, Biological: IpilimumabNivolumab 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
Arm N-I, Level 2b: Nivolumab+Ipilimumab	Experimental	Biological: Nivolumab, Biological: IpilimumabNivolumab 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
Arm N-I, Level 2c: Nivolumab+Ipilimumab	Experimental	Biological: Nivolumab, Biological: IpilimumabNivolumab 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
Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib	Experimental	Biological: Nivolumab, Biological: Ipilimumab, Drug: CobimetinibNivolumab 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NivolumabAlso: BMS-936558, MDX-1106	Biological	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
IpilimumabAlso: Yervoy, BMS-734016, MDX-010	Biological	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
CobimetinibAlso: Cotellic	Drug	Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib

Primary outcome

Objective Response Rate ( ORR )
Time frame: 60 months
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.

Results and safety

Results posted to the registry on 24 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TNBC Arm N	18	0
TNBC Arm N-I Dose Level 1	3	0
TNBC Arm N-I Dose Level 2	18	0
GC Arm N	59	3
GC Arm N-I Dose Level 1	3	0
GC Arm N-I Dose Level 2	49	6
GC Arm N-I Dose Level 2b	52	3
PC Arm N	18	0
PC Arm N-I Dose Level 1	3	0
PC Arm N-I Dose Level 2	18	0
PC Arm N-I Dose Level 2d	30	0
SCLC Arm N - Pre-expansion	98	5
SCLC Arm N-I Dose Level 2 - Pre-expansion	61	6
SCLC Arm N Expansion	147	8
SCLC Arm N-I Dose Level 2- Expansion	96	8
SCLC Arm N-I Dose Level 1 -	3	1
SCLC Arm N-I Dose Level 2b	55	5
BC Arm N	78	7
BC Arm N-I Dose Level 2	92	22
BC Arm N-I Dose Level 2b	104	8
OC Arm N-I Dose Level 2	41	1
OC Arm N-I Dose Level 2b	43	1
OC Arm N-I Dose Level 2c:	42	3

Primary outcome: Objective Response Rate ( ORR )

Time frame: 60 months. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	TNBC Arm N n = 18	TNBC Arm N-I Dose Level 1 n = 3	TNBC Arm N-I Dose Level 2 n = 18	GC Arm N n = 59	GC Arm N-I Dose Level 1 n = 3	GC Arm N-I Dose Level 2 n = 49	GC Arm N-I Dose Level 2b n = 52	PC Arm N n = 18	PC Arm N-I Dose Level 1 n = 3	PC Arm N-I Dose Level 2 n = 18	PC Arm N-I Dose Level 2d n = 30	SCLC Arm N - Pre-expansion n = 98	SCLC Arm N-I Dose Level 2 - Pre-expansion n = 61	SCLC Arm N Expansion n = 147	SCLC Arm N-I Dose Level 2- Expansion n = 96	SCLC Arm N-I Dose Level 1 - n = 3	SCLC Arm N-I Dose Level 2b n = 55	SCLC Arm N- All Treated n = 245	SCLC Arm N-I Dose Level 2 - All Treated n = 157	BC Arm N n = 78	BC Arm N-I Dose Level 2 n = 92	BC Arm N-I Dose Level 2b n = 104	OC Arm N-I Dose Level 2 n = 41	OC Arm N-I Dose Level 2b: n = 43	OC Arm N-I Dose Level 2c: n = 42
Value	5.6 (0.1 to 27.3)	0.0 (0.0 to 70.8)	0.0 (0.0 to 18.5)	11.9 (4.9 to 22.9)	0.0 (0.0 to 70.8)	24.5 (13.3 to 38.9)	7.7 (2.1 to 18.5)	0.0 (0 to 18.5)	0.0 (0.0 to 70.8)	0.0 (0.0 to 18.5)	6.7 (0.8 to 22.1)	13.3 (7.3 to 21.6)	26.2 (15.8 to 39.1)	11.6 (6.9 to 17.9)	21.9 (14.1 to 31.5)	33.3 (0.8 to 90.6)	18.2 (9.1 to 30.9)	11.8 (8.1 to 16.6)	22.3 (16.0 to 29.6)	25.6 (16.4 to 36.8)	38.0 (28.1 to 48.8)	26.9 (18.7 to 36.5)	12.2 (4.1 to 26.2)	7.0 (1.5 to 19.1)	9.5 (2.7 to 22.6)

SCLC Arm N Expansion vs SCLC Arm N-I Dose Level 2- Expansion: Odds Ratio (OR): 2.12 (95% CI 1.06 to 4.26), p = 0.0309, Cochran-Mantel-Haenszel

Population analysed: All Treated Participants

Adverse events

Time frame: Includes events reported between first dose and 30 days (AEs) or 100 days (SAEs) after last dose of study therapy. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TNBC Arm N	9 of 18 (50%)	18 of 18 (100%)	17 of 18
TNBC Arm N-I Dose Level 1	2 of 3 (66.7%)	3 of 3 (100%)	3 of 3
TNBC Arm N-I Dose Level 2	11 of 18 (61.1%)	17 of 18 (94.4%)	18 of 18
GC Arm N	32 of 59 (54.2%)	58 of 59 (98.3%)	53 of 59
GC Arm N-I Dose Level 1	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
GC Arm N-I Dose Level 2	37 of 49 (75.5%)	47 of 49 (95.9%)	42 of 49
GC Arm N-I Dose Level 2b	34 of 52 (65.4%)	49 of 52 (94.2%)	50 of 52
PC Arm N	10 of 18 (55.6%)	18 of 18 (100%)	18 of 18
PC Arm N-I Dose Level 1	3 of 3 (100%)	3 of 3 (100%)	3 of 3
PC Arm N-I Dose Level 2	11 of 18 (61.1%)	17 of 18 (94.4%)	18 of 18
PC Arm N-I Dose Level 2d	16 of 30 (53.3%)	29 of 30 (96.7%)	24 of 30
SCLC Arm N	129 of 245 (52.7%)	226 of 245 (92.2%)	212 of 245
SCLC Arm N-I Dose Level 2	111 of 157 (70.7%)	147 of 157 (93.6%)	136 of 157
SCLC Arm N-I Dose Level 1	2 of 3 (66.7%)	3 of 3 (100%)	3 of 3
SCLC Arm N-I Dose Level 2b	32 of 55 (58.2%)	53 of 55 (96.4%)	45 of 55
BC Arm N	41 of 78 (52.6%)	77 of 78 (98.7%)	60 of 78
BC Arm N-I Dose Level 2	62 of 92 (67.4%)	85 of 92 (92.4%)	54 of 92
BC Arm N-I Dose Level 2b	72 of 104 (69.2%)	100 of 104 (96.2%)	82 of 104
OC Arm N-I Dose Level 2	24 of 41 (58.5%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31100038Sharma 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.
Derived from this study: PubMed 30110194Janjigian 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.
Derived from this study: PubMed 29489427Teo 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.
Derived from this study: PubMed 27733243Sharma 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.
Derived from this study: PubMed 27269741Antonia 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.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

38 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nivolumab, Ipilimumab and Cobimetinib in people with Advanced or Metastatic Solid Tumors, run by Bristol-Myers Squibb at 38 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Germany, Italy, Spain, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate ( ORR ) (time frame: 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01928394, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.