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CompletedNCT01928394Updated Dec 27, 2024Results posted

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

A Phase 1/2 interventional study of Nivolumab and Ipilimumab in Advanced or Metastatic Solid Tumors, sponsored by Bristol-Myers Squibb. Completed at 38 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
1,163
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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

02

Conditions studied

  • Advanced or Metastatic Solid Tumors

Browse trials for

03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 1,163 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Inclusion criteria

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,163 participants (actual)

Study arms

  • Experimental
    Arm N - Nivolumab

    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

  • Experimental
    Arm N-I, Level 1: Nivolumab+Ipilimumab

    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

  • Experimental
    Arm N-I, Level 2: Nivolumab+Ipilimumab

    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

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

    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

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

    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

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

    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

  • BiologicalNivolumab

    Also known as: BMS-936558, MDX-1106

  • BiologicalIpilimumab

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

  • DrugCobimetinib

    Also known as: Cotellic

06

What researchers measure

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.

    Time frame: 60 months

07

Results

Posted Mar 24, 2020

Participant flow

Treatment Period
Participant flow — Treatment Period
MilestoneTNBC Arm NTNBC Arm N-I Dose Level 1TNBC Arm N-I Dose Level 2GC Arm NGC Arm N-I Dose Level 1GC Arm N-I Dose Level 2GC Arm N-I Dose Level 2bPC Arm NPC Arm N-I Dose Level 1PC Arm N-I Dose Level 2PC Arm N-I Dose Level 2dSCLC Arm N - Pre-expansionSCLC Arm N-I Dose Level 2 - Pre-expansionSCLC Arm N ExpansionSCLC Arm N-I Dose Level 2- ExpansionSCLC Arm N-I Dose Level 1 -SCLC Arm N-I Dose Level 2bBC Arm NBC Arm N-I Dose Level 2BC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2OC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2c:
Started18318593495218318309861147963557892104414342
Transition3009000200017020002000000
Transition- continued0030036011001702000119000
Completed000306300005688157228113
Not completed1831856343491831830935513988250717096404239
Withdrew: Disease progression1721248325381631122733811859143565071303131
Withdrew: Study drug toxicity11330971052375120331215474
Withdrew: Ae unrelated to study drug0023051002012613611635110
Withdrew: Participant request to stop therapy00000330003212401311313
Withdrew: Participant withdrew consent00110101001110202111020
Withdrew: Poor/non-compliance00010000000010100101000
Withdrew: Other reason00000000001110100022000
Withdrew: Maximum clinical benefit00000000001100100110200
Withdrew: Lost to follow-up00000000000000000000001
Withdrew: Death00000000000001200000000
Follow-up Period
Participant flow — Follow-up Period
MilestoneTNBC Arm NTNBC Arm N-I Dose Level 1TNBC Arm N-I Dose Level 2GC Arm NGC Arm N-I Dose Level 1GC Arm N-I Dose Level 2GC Arm N-I Dose Level 2bPC Arm NPC Arm N-I Dose Level 1PC Arm N-I Dose Level 2PC Arm N-I Dose Level 2dSCLC Arm N - Pre-expansionSCLC Arm N-I Dose Level 2 - Pre-expansionSCLC Arm N ExpansionSCLC Arm N-I Dose Level 2- ExpansionSCLC Arm N-I Dose Level 1 -SCLC Arm N-I Dose Level 2bBC Arm NBC Arm N-I Dose Level 2BC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2OC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2c:
Started15318503495216318308161145963555892104414342
Completed1231540341401021619594710766341507683323436
Not completed303100812612112214383001481621996
Withdrew: Participant withdrew consent301402510058212705327462
Withdrew: Death00260662124121125180651313532
Withdrew: Other reason00000013002101402011001
Withdrew: Lost to follow-up00000000000110101000001

Outcome measures

PrimaryObjective 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.

Time frame:
60 months
Reported as:
Number · Percentage of Participants
Objective Response Rate ( ORR )
Percentage of ParticipantsTNBC Arm NTNBC Arm N-I Dose Level 1TNBC Arm N-I Dose Level 2GC Arm NGC Arm N-I Dose Level 1GC Arm N-I Dose Level 2GC Arm N-I Dose Level 2bPC Arm NPC Arm N-I Dose Level 1PC Arm N-I Dose Level 2PC Arm N-I Dose Level 2dSCLC Arm N - Pre-expansionSCLC Arm N-I Dose Level 2 - Pre-expansionSCLC Arm N ExpansionSCLC Arm N-I Dose Level 2- ExpansionSCLC Arm N-I Dose Level 1 -SCLC Arm N-I Dose Level 2bSCLC Arm N- All TreatedSCLC Arm N-I Dose Level 2 - All TreatedBC Arm NBC Arm N-I Dose Level 2BC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2OC Arm N-I Dose Level 2b:OC Arm N-I Dose Level 2c:
Objective Response Rate ( ORR )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)
Statistical analysis
  • SCLC Arm N Expansion vs SCLC Arm N-I Dose Level 2- Expansion · Cochran-Mantel-Haenszel · p = 0.0309 · Odds ratio (or): 2.12 · 95% CI 1.06 to 4.26

Adverse events

Collected over Includes events reported between first dose and 30 days (AEs) or 100 days (SAEs) after last dose of study therapy. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TNBC Arm N17/18 (94.4%)9/18 (50%)18/18 (100%)
TNBC Arm N-I Dose Level 13/3 (100%)2/3 (66.7%)3/3 (100%)
TNBC Arm N-I Dose Level 218/18 (100%)11/18 (61.1%)17/18 (94.4%)
GC Arm N53/59 (89.8%)32/59 (54.2%)58/59 (98.3%)
GC Arm N-I Dose Level 13/3 (100%)1/3 (33.3%)3/3 (100%)
GC Arm N-I Dose Level 242/49 (85.7%)37/49 (75.5%)47/49 (95.9%)
GC Arm N-I Dose Level 2b50/52 (96.2%)34/52 (65.4%)49/52 (94.2%)
PC Arm N18/18 (100%)10/18 (55.6%)18/18 (100%)
PC Arm N-I Dose Level 13/3 (100%)3/3 (100%)3/3 (100%)
PC Arm N-I Dose Level 218/18 (100%)11/18 (61.1%)17/18 (94.4%)
PC Arm N-I Dose Level 2d24/30 (80%)16/30 (53.3%)29/30 (96.7%)
SCLC Arm N212/245 (86.5%)129/245 (52.7%)226/245 (92.2%)
SCLC Arm N-I Dose Level 2136/157 (86.6%)111/157 (70.7%)147/157 (93.6%)
SCLC Arm N-I Dose Level 13/3 (100%)2/3 (66.7%)3/3 (100%)
SCLC Arm N-I Dose Level 2b45/55 (81.8%)32/55 (58.2%)53/55 (96.4%)
BC Arm N60/78 (76.9%)41/78 (52.6%)77/78 (98.7%)
BC Arm N-I Dose Level 254/92 (58.7%)62/92 (67.4%)85/92 (92.4%)
BC Arm N-I Dose Level 2b82/104 (78.8%)72/104 (69.2%)100/104 (96.2%)
OC Arm N-I Dose Level 233/41 (80.5%)24/41 (58.5%)38/41 (92.7%)
OC Arm N-I Dose Level 2b37/43 (86%)31/43 (72.1%)40/43 (93%)
OC Arm N-I Dose Level 2c34/42 (81%)29/42 (69%)41/42 (97.6%)
Most frequent serious events
Showing 10 of 310
Most frequent serious events
EventTNBC Arm NTNBC Arm N-I Dose Level 1TNBC Arm N-I Dose Level 2GC Arm NGC Arm N-I Dose Level 1GC Arm N-I Dose Level 2GC Arm N-I Dose Level 2bPC Arm NPC Arm N-I Dose Level 1PC Arm N-I Dose Level 2PC Arm N-I Dose Level 2dSCLC Arm NSCLC Arm N-I Dose Level 2SCLC Arm N-I Dose Level 1SCLC Arm N-I Dose Level 2bBC Arm NBC Arm N-I Dose Level 2BC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2OC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2c
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)4/180/32/189/591/37/497/523/182/34/183/3054/24535/1571/313/557/7813/9210/1042/412/434/42
Cardiac failure congestiveCardiac disorders0/181/30/180/590/30/490/520/180/30/180/301/2450/1570/30/550/780/920/1040/410/430/42
Abdominal distensionGastrointestinal disorders0/180/30/180/590/30/491/520/181/30/180/300/2450/1570/30/550/780/920/1040/410/430/42
Abdominal painGastrointestinal disorders0/180/30/183/590/30/490/523/181/32/181/301/2451/1570/30/553/783/923/1042/413/434/42
ConstipationGastrointestinal disorders0/180/30/181/590/30/490/520/181/30/181/302/2451/1570/30/551/780/923/1040/413/431/42
Non-cardiac chest painGeneral disorders0/181/30/180/590/30/490/520/180/30/180/301/2450/1570/30/551/781/921/1040/410/431/42
Respiratory tract infection viralInfections and infestations0/180/30/180/590/30/490/520/180/30/180/300/2450/1571/30/550/780/920/1040/410/430/42
SinusitisInfections and infestations0/180/30/180/590/31/490/520/180/30/180/300/2450/1571/30/550/781/920/1040/410/430/42
DehydrationMetabolism and nutrition disorders1/180/30/181/590/30/490/520/180/30/180/304/2454/1571/30/551/781/921/1041/410/431/42
DyspnoeaRespiratory, thoracic and mediastinal disorders3/181/31/185/591/31/490/520/180/30/180/306/2453/1570/30/553/782/928/1040/411/433/42
Most frequent other events
Showing 10 of 253
Most frequent other events
EventTNBC Arm NTNBC Arm N-I Dose Level 1TNBC Arm N-I Dose Level 2GC Arm NGC Arm N-I Dose Level 1GC Arm N-I Dose Level 2GC Arm N-I Dose Level 2bPC Arm NPC Arm N-I Dose Level 1PC Arm N-I Dose Level 2PC Arm N-I Dose Level 2dSCLC Arm NSCLC Arm N-I Dose Level 2SCLC Arm N-I Dose Level 1SCLC Arm N-I Dose Level 2bBC Arm NBC Arm N-I Dose Level 2BC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2OC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2c
NauseaGastrointestinal disorders6/181/36/1821/593/315/4914/526/180/310/1812/3055/24538/1572/317/5523/7825/9233/10416/4121/4318/42
FatigueGeneral disorders8/182/37/1832/592/322/4928/5211/181/313/1822/3089/24567/1572/325/5546/7836/9252/10421/4124/4327/42
DiarrhoeaGastrointestinal disorders3/181/311/1817/591/315/498/524/181/310/1821/3054/24545/1572/317/5517/7844/9238/10413/4119/4316/42
ConstipationGastrointestinal disorders2/181/35/1815/592/39/4916/526/180/36/185/3049/24534/1570/312/5516/7819/9228/1049/4114/4310/42
DyspepsiaGastrointestinal disorders0/180/30/184/592/30/491/520/180/32/183/308/2453/1571/31/552/785/924/1043/412/434/42
VomitingGastrointestinal disorders0/180/35/1818/592/39/4916/527/181/34/1815/3037/24526/1570/311/5513/7819/9219/1049/4113/4311/42
Decreased appetiteMetabolism and nutrition disorders3/180/32/1821/592/314/4919/526/180/37/1811/3067/24550/1571/315/5514/7821/9236/10410/4111/4313/42
HypocalcaemiaMetabolism and nutrition disorders0/180/33/183/590/32/496/521/182/31/180/301/2451/1570/30/552/783/928/1041/410/433/42
HypokalaemiaMetabolism and nutrition disorders1/180/32/187/590/32/493/521/182/33/182/3018/24513/1570/35/556/787/929/1044/412/434/42
AgitationPsychiatric disorders0/180/30/181/590/30/492/520/182/30/180/301/2451/1570/30/550/783/922/1040/410/430/42

Baseline characteristics

Age, Continuous
Age, Continuous(Years)TNBC Arm NTNBC Arm N-I Dose Level 1TNBC Arm N-I Dose Level 2GC Arm NGC Arm N-I Dose Level 1GC Arm N-I Dose Level 2GC Arm N-I Dose Level 2bPC Arm NPC Arm N-I Dose Level 1PC Arm N-I Dose Level 2PC Arm N-I Dose Level 2dSCLC Arm N - Pre-expansionSCLC Arm N-I Dose Level 2 - Pre-expansionSCLC Arm N ExpansionSCLC Arm N-I Dose Level 2- ExpansionSCLC Arm N-I Dose Level 1 -SCLC Arm N-I Dose Level 2bBC Arm NBC Arm N-I Dose Level 2BC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2OC Arm N-I Dose Level 2b:OC Arm N-I Dose Level 2c:Total
Mean53.3 ± 11.952.7 ± 9.549.1 ± 9.057.2 ± 10.9967.0 ± 9.5453.2 ± 12.5856.4 ± 13.4063.2 ± 9.7058.3 ± 9.8764.1 ± 9.2162.1 ± 11.5162.6 ± 8.5063.9 ± 9.9462.8 ± 9.0963.7 ± 9.0659.3 ± 6.760.1 ± 7.7464.1 ± 10.8663.9 ± 9.5464.1 ± 9.6956.7 ± 11.159.6 ± 10.958.7 ± 12.261.2 ± 10.7
Age, Customized
Age, Customized(Participants)TNBC Arm NTNBC Arm N-I Dose Level 1TNBC Arm N-I Dose Level 2GC Arm NGC Arm N-I Dose Level 1GC Arm N-I Dose Level 2GC Arm N-I Dose Level 2bPC Arm NPC Arm N-I Dose Level 1PC Arm N-I Dose Level 2PC Arm N-I Dose Level 2dSCLC Arm N - Pre-expansionSCLC Arm N-I Dose Level 2 - Pre-expansionSCLC Arm N ExpansionSCLC Arm N-I Dose Level 2- ExpansionSCLC Arm N-I Dose Level 1 -SCLC Arm N-I Dose Level 2bBC Arm NBC Arm N-I Dose Level 2BC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2OC Arm N-I Dose Level 2b:OC Arm N-I Dose Level 2c:Total
< 651631842139355291355278247238374757302625656
>= 65 and < 7510015181212171434275139117313429101412370
>= 751002125102397141000101118135105
>= 65200172101713191743346549117414547111717475
Sex: Female, Male
Sex: Female, Male(Participants)TNBC Arm NTNBC Arm N-I Dose Level 1TNBC Arm N-I Dose Level 2GC Arm NGC Arm N-I Dose Level 1GC Arm N-I Dose Level 2GC Arm N-I Dose Level 2bPC Arm NPC Arm N-I Dose Level 1PC Arm N-I Dose Level 2PC Arm N-I Dose Level 2dSCLC Arm N - Pre-expansionSCLC Arm N-I Dose Level 2 - Pre-expansionSCLC Arm N ExpansionSCLC Arm N-I Dose Level 2- ExpansionSCLC Arm N-I Dose Level 1 -SCLC Arm N-I Dose Level 2bBC Arm NBC Arm N-I Dose Level 2BC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2OC Arm N-I Dose Level 2b:OC Arm N-I Dose Level 2c:Total
Female183181411575281237266135123241823414342477
Male0004523445131101861358661232547481000654
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TNBC Arm NTNBC Arm N-I Dose Level 1TNBC Arm N-I Dose Level 2GC Arm NGC Arm N-I Dose Level 1GC Arm N-I Dose Level 2GC Arm N-I Dose Level 2bPC Arm NPC Arm N-I Dose Level 1PC Arm N-I Dose Level 2PC Arm N-I Dose Level 2dSCLC Arm N - Pre-expansionSCLC Arm N-I Dose Level 2 - Pre-expansionSCLC Arm N ExpansionSCLC Arm N-I Dose Level 2- ExpansionSCLC Arm N-I Dose Level 1 -SCLC Arm N-I Dose Level 2bBC Arm NBC Arm N-I Dose Level 2BC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2OC Arm N-I Dose Level 2b:OC Arm N-I Dose Level 2c:Total
Hispanic or Latino0001012001030000120411118
Not Hispanic or Latino10394122935163132863479755226593873262932736
Unknown or Not Reported809171191520423214504112817542714139377
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TNBC Arm NTNBC Arm N-I Dose Level 1TNBC Arm N-I Dose Level 2GC Arm NGC Arm N-I Dose Level 1GC Arm N-I Dose Level 2GC Arm N-I Dose Level 2bPC Arm NPC Arm N-I Dose Level 1PC Arm N-I Dose Level 2PC Arm N-I Dose Level 2dSCLC Arm N - Pre-expansionSCLC Arm N-I Dose Level 2 - Pre-expansionSCLC Arm N ExpansionSCLC Arm N-I Dose Level 2- ExpansionSCLC Arm N-I Dose Level 1 -SCLC Arm N-I Dose Level 2bBC Arm NBC Arm N-I Dose Level 2BC Arm N-I Dose Level 2bOC Arm N-I Dose Level 2OC Arm N-I Dose Level 2b:OC Arm N-I Dose Level 2c:Total
American Indian or Alaska Native000000000001000000000001
Asian1000010101110210011420118
Native Hawaiian or Other Pacific Islander000000000000000000000000
Black or African American3013011101431751043410246
White14317563465016316239160134872547287903743381042
More than one race000000000000000000000000
Unknown or Not Reported0000011000220430111610124
08

Study locations

38 sites
  • Local Institution - 0047
    Muscle Shoals, Alabama 35661, United States
  • Local Institution - 0044
    Aurora, Colorado 80045, United States
  • Local Institution - 0015
    New Haven, Connecticut 06520, United States
  • Local Institution - 0046
    Gainesville, Florida 32610, United States
  • Local Institution - 0021
    Tampa, Florida 33612, United States
  • Local Institution - 0001
    Atlanta, Georgia 30322, United States
  • Local Institution - 0004
    Baltimore, Maryland 21287, United States
  • Local Institution - 0005
    Boston, Massachusetts 02215, United States
  • Local Institution - 0043
    Boston, Massachusetts 02215, United States
  • Local Institution - 0049
    Omaha, Nebraska 68130, United States
  • Local Institution - 0045
    Mineola, New York 11501, United States
  • Local Institution - 0006
    New York, New York 10065, United States
  • Local Institution - 0003
    Charlotte, North Carolina 28204, United States
  • Local Institution - 0008
    Durham, North Carolina 27710, United States
  • Local Institution - 0007
    Portland, Oregon 97239, United States
  • Local Institution - 0011
    Franklin, Tennessee 37067, United States
  • Local Institution - 0002
    Nashville, Tennessee 37232, United States
  • Local Institution - 0009
    Houston, Texas 77030, United States
  • Local Institution - 0042
    Seattle, Washington 98104, United States
  • Local Institution - 0038
    Toronto, Ontario M5G 2M9, Canada
  • Local Institution - 0039
    Copenhagen, 2100, Denmark
  • Local Institution - 0014
    Helsinki, Uusimaa 00290, Finland
  • Local Institution - 0036
    Tampere, 33521, Finland
  • Local Institution - 0048
    Bonn, 53105, Germany
  • Local Institution - 0026
    Frankfurt, 60488, Germany
  • Local Institution - 0016
    Heidelberg, 69120, Germany
  • Local Institution - 0050
    Kassel, 34125, Germany
  • Local Institution - 0024
    Bologna, 40138, Italy
  • Local Institution - 0019
    Milano, 20133, Italy
  • Local Institution - 0020
    Napoli, 80131, Italy
  • Local Institution - 0032
    Padova, 35128, Italy
  • Local Institution - 0037
    Barcelona, 08036, Spain
  • Local Institution - 0023
    Madrid, 28040, Spain
  • Local Institution - 0017
    Madrid, 28041, Spain
  • Local Institution - 0010
    Madrid, 28050, Spain
  • Local Institution - 0018
    London, Greater London SW3 6JJ, United Kingdom
  • Local Institution - 0012
    Glasgow, Lanarkshire G12 0YN, United Kingdom
  • Local Institution - 0013
    Sutton, Surrey SM2 5PT, United Kingdom
09

References and documents

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. Erratum In: J Clin Oncol. 2019 Aug 10;37(23):2094. doi: 10.1200/JCO.19.01700. 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. Erratum In: Lancet Oncol. 2016 Jul;17(7):e270. doi: 10.1016/S1470-2045(16)30221-2. Lancet Oncol. 2019 Feb;20(2):e70. doi: 10.1016/S1470-2045(19)30018-X. PubMed 27269741 ↗

Study documents

  • Study protocol · Oct 3, 2019
  • Statistical analysis plan · Nov 12, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01928394
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Aug 23, 2013
Start date
Oct 24, 2013
Primary completion
Feb 5, 2019
Completion
Nov 18, 2024
Results posted
Mar 24, 2020
Last update
Dec 27, 2024

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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