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

Conditions

Advanced or Metastatic Solid Tumors

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

Cindy M. Pabon, Lianchun Xiao, Brian D. Badgwell, Paul F. Mansfield, Naruhiko Ikoma et al. (20 authors)

Journal of Clinical Oncology2024-06-012 citations

10.1200/jco.2024.42.16_suppl.4067

Abstract 2047: Association of retinoblastoma function with response to immuno-oncology treatment in patients with small cell lung cancer

David Balli, Xuya Wang, Naiyer A. Rizvi, Timothy A. Chan, Afshin Dowlati et al. (7 authors)

Cancer Research2020-08-152 citations

10.1158/1538-7445.am2020-2047

Nivolumab Monotherapy and Nivolumab Plus Ipilimumab in Recurrent Small Cell Lung Cancer: Results From the CheckMate 032 Randomized Cohort.

Ready NE, Ott PA, Hellmann MD, Zugazagoitia J, Hann CL, de Braud F, Antonia SJ, Ascierto PA, Moreno V, Atmaca A, Salvagni S, Taylor M, Amin A, Camidge DR, Horn L, Calvo E, Li A, Lin WH, Callahan MK, Spigel DR.

2019-10-17223 citations

10.1016/j.jtho.2019.10.004

Nivolumab safety profile in Asian and Western patients with chemotherapy-refractory (CTx-R) advanced gastric/gastroesophageal junction (adv G/GEJ) cancer from the ATTRACTION-2 and CheckMate-032 trials.

Ian Chau, Li‐Tzong Chen, Yoon‐Koo Kang, Taroh Satoh, Ken Kato et al. (15 authors)

Journal of Clinical Oncology2018-05-203 citations

10.1200/jco.2018.36.15_suppl.e15127

Health Status in Patients With Small Cell Lung Cancer (SCLC) Treated With Nivolumab Alone or Combined With Ipilimumab: CheckMate 032

Akin Atmaca, Andrea Ardizzoni, A. Farago, Emiliano Calvo, Fiona Taylor et al. (11 authors)

Pneumologie2018-02-21

10.1055/s-0037-1619269

Nivolumab monotherapy in metastatic urothelial carcinoma: Longer-term efficacy and safety results from the CheckMate 032 study.

Padmanee Sharma, Margaret K. Callahan, Petri Bono, Joseph W. Kim, Pavlina Spiliopoulou et al. (19 authors)

Journal of Clinical Oncology2018-02-2011 citations

10.1200/jco.2018.36.6_suppl.414

Nivolumab safety profile in Asian and Western patients with chemotherapy-refractory (CTx-R) advanced gastric/gastroesophageal junction (adv G/GEJ) cancer from the ATTRACTION-2 and CheckMate-032 trials.

Ian Chau, Li‐Tzong Chen, Yoon‐Koo Kang, Taroh Satoh, Ken Kato et al. (15 authors)

Journal of Clinical Oncology2018-02-012 citations

10.1200/jco.2018.36.4_suppl.90

Evaluation of Maintenance Pembrolizumab in Extensive Small Cell Lung Cancer Patients

Richard Simoneaux

Oncology Times2017-08-16

10.1097/01.cot.0000524497.56334.44

Nivolumab (N)± Ipilimumab (I) bei Patienten mit fortgeschrittenem/metastasiertem chemotherapie-refraktärem (CTx-R) Magenkrebs (G), Speiseröhrenkrebs (E) oder Adenokarzinom des ösophagogastralen Übergangs (GEJ): CheckMate 032 Studie

Y. Y. Janjigian, Dirk Jäger, A. Ott, Emiliano Calvo, JW Kim et al. (16 authors)

Zeitschrift für Gastroenterologie2017-08-01

10.1055/s-0037-1604772

Nivolumab (nivo) ± ipilimumab (ipi) in advanced small-cell lung cancer (SCLC): First report of a randomized expansion cohort from CheckMate 032.

Matthew D. Hellmann, Patrick A. Ott, Jon Zugazagoitia, Neal Ready, Christine L. Hann et al. (20 authors)

Journal of Clinical Oncology2017-05-2084 citations

10.1200/jco.2017.35.15_suppl.8503

Nivolumab ± ipilimumab in pts with advanced (adv)/metastatic chemotherapy-refractory (CTx-R) gastric (G), esophageal (E), or gastroesophageal junction (GEJ) cancer: CheckMate 032 study.

Yelena Y. Janjigian, Patrick A. Ott, Emiliano Calvo, Joseph W. Kim, Paolo A. Ascierto et al. (16 authors)

Journal of Clinical Oncology2017-05-2070 citations

10.1200/jco.2017.35.15_suppl.4014

Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial.

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.

2016-10-09509 citations

10.1016/s1470-2045(16)30496-x

Acute rhabdomyolysis with severe polymyositis following ipilimumab-nivolumab treatment in a cancer patient with elevated anti-striated muscle antibody.

Bilen MA, Subudhi SK, Gao J, Tannir NM, Tu SM, Sharma P.

2016-06-2179 citations

10.1186/s40425-016-0139-8

Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial.

Antonia SJ, López-Martin JA, Bendell J, Ott PA, Taylor M, Eder JP, Jäger 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.

2016-06-04967 citations

10.1016/s1470-2045(16)30098-5

CheckMate-032: Phase I/II, open-label study of safety and activity of nivolumab (nivo) alone or with ipilimumab (ipi) in advanced and metastatic (A/M) gastric cancer (GC).

Yelena Y. Janjigian, Johanna C. Bendell, Emiliano Calvo, Joseph W. Kim, Paolo A. Ascierto et al. (16 authors)

Journal of Clinical Oncology2016-05-2087 citations

10.1200/jco.2016.34.15_suppl.4010

Efficacy and safety of nivolumab monotherapy in metastatic urothelial cancer (mUC): Results from the phase I/II CheckMate 032 study.

Padmanee Sharma, Petri Bono, Joseph W. Kim, Pavlina Spiliopoulou, Emiliano Calvo et al. (17 authors)

Journal of Clinical Oncology2016-05-2049 citations

10.1200/jco.2016.34.15_suppl.4501

Checkmate 032: Nivolumab (N) alone or in combination with ipilimumab (I) for the treatment of recurrent small cell lung cancer (SCLC).

Scott Antonia, José A. López-Martín, Johanna C. Bendell, Patrick A. Ott, Matthew H. Taylor et al. (19 authors)

Journal of Clinical Oncology2016-05-2016 citations

10.1200/jco.2016.34.15_suppl.100

Safety and activity of nivolumab monotherapy in advanced and metastatic (A/M) gastric or gastroesophageal junction cancer (GC/GEC): Results from the CheckMate-032 study.

Dung T. Le, Johanna C. Bendell, Emiliano Calvo, Joseph W. Kim, Paolo A. Ascierto et al. (16 authors)

Journal of Clinical Oncology2016-02-0162 citations

10.1200/jco.2016.34.4_suppl.6

Phase I/II, open-label study of nivolumab (anti-PD-1; BMS-936558, ONO-4538) as monotherapy or combined with ipilimumab in advanced or metastatic solid tumors.

Margaret K. Callahan, Johanna C. Bendell, Emily Chan, Michael A. Morse, Rathi N. Pillai et al. (18 authors)

Journal of Clinical Oncology2014-05-2024 citations

10.1200/jco.2014.32.15_suppl.tps3114

Interventions

BIOLOGICALNivolumab

BIOLOGICALIpilimumab

DRUGCobimetinib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Objective Response Rate ( ORR )	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.

Countries

Canada, Denmark, Finland, Germany, Italy, Spain, United Kingdom, United States

Participant flow

Pre-assignment details

1131 participants were treated in total for TNBC, GC, PC, SCLC, BC and OC.

Participants by arm

Arm	Count
TNBC Arm N Triple Negative Breast Cancer (TNBC) Nivolumab monotherapy (3 mg/kg) Q2W	18
TNBC Arm N-I Dose Level 1 Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W	3
TNBC Arm N-I Dose Level 2 Triple Negative Breast Cancer (TNBC) Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W	18
GC Arm N Gastric Cancer (GC) Nivolumab 3 mg/kg Q2W	59
GC Arm N-I Dose Level 1 Gastric Cancer(GC) Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W	3
GC Arm N-I Dose Level 2 Gastric Cancer (GC) nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses; then nivolumab 3 mg/kg Q2W	49
GC Arm N-I Dose Level 2b Gastric Cancer (GC) Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W	52
PC Arm N Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg Q2W	18
PC Arm N-I Dose Level 1 Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W	3
PC Arm N-I Dose Level 2 Pancreatic cancer (PC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W	18
PC Arm N-I Dose Level 2d Pancreatic cancer (PC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q6W for 4 doses + cobimetinib 60 mg po qd 21 days on/7 days off	30
SCLC Arm N - Pre-expansion Small cell lung cancer (SCLC) participants treated in Pre-expansion Cohort with Nivolumab 3 mg/kg Q2W	98
SCLC Arm N-I Dose Level 2 - Pre-expansion Small cell lung cancer (SCLC) treated participants in Pre-expansion cohort treated with Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W	61
SCLC Arm N Expansion Small cell lung cancer (SCLC) expansion cohort participants:Nivolumab monotherapy (3 mg/kg) Q2W	147
SCLC Arm N-I Dose Level 2- Expansion Small cell lung cancer (SCLC) expansion cohort participants Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2Wi	96
SCLC Arm N-I Dose Level 1 - Small cell lung cancer (SCLC) participants treated with Nivolumab (1 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3mg/kg) Q2W	3
SCLC Arm N-I Dose Level 2b Small cell lung cancer (SCLC) treated participants treated with Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W	55
BC Arm N Bladder cancer (BC) participants: Nivolumab 3 mg/kg Q2W	78
BC Arm N-I Dose Level 2 Bladder cancer (BC) participants: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W	92
BC Arm N-I Dose Level 2b Bladder cancer (BC) participants: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q3W for 4 doses, then Nivolumab (3 mg/kg) Q2W	104
OC Arm N-I Dose Level 2 Ovarian cancer (OC) participants: Nivolumab (1 mg/kg) + ipilimumab (3 mg/kg) Q3W for 4 doses, then nivolumab (3 mg/kg) Q2W	41
OC Arm N-I Dose Level 2b: Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) + ipilimumab (1 mg/kg) Q3W for 4 doses,then nivolumab (3 mg/kg) Q2W	43
OC Arm N-I Dose Level 2c: Ovarian cancer (OC) participants: Nivolumab (3 mg/kg) Q2W + ipilimumab (1 mg/kg) Q6W	42
Total	1,131

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011	FG012	FG013	FG014	FG015	FG016	FG017	FG018	FG019	FG020	FG021	FG022
Follow-up Period	Death	0	0	2	6	0	6	6	2	1	2	4	12	11	25	18	0	6	5	13	13	5	3	2
Follow-up Period	Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	1	1	0	1	0	1	0	0	0	0	0	1
Follow-up Period	other reason	0	0	0	0	0	0	1	3	0	0	2	1	0	1	4	0	2	0	1	1	0	0	1
Follow-up Period	Participant withdrew consent	3	0	1	4	0	2	5	1	0	0	5	8	2	12	7	0	5	3	2	7	4	6	2
Treatment Period	AE unrelated to study drug	0	0	2	3	0	5	1	0	0	2	0	12	6	13	6	1	1	6	3	5	1	1	0
Treatment Period	Death	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	0
Treatment Period	Disease progression	17	2	12	48	3	25	38	16	3	11	22	73	38	118	59	1	43	56	50	71	30	31	31
Treatment Period	Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Treatment Period	Maximum clinical benefit	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1	0	0	1	1	0	2	0	0
Treatment Period	other reason	0	0	0	0	0	0	0	0	0	0	1	1	1	0	1	0	0	0	2	2	0	0	0
Treatment Period	Participant request to stop therapy	0	0	0	0	0	3	3	0	0	0	3	2	1	2	4	0	1	3	1	1	3	1	3
Treatment Period	Participant withdrew consent	0	0	1	1	0	1	0	1	0	0	1	1	1	0	2	0	2	1	1	1	0	2	0
Treatment Period	Poor/non-compliance	0	0	0	1	0	0	0	0	0	0	0	0	1	0	1	0	0	1	0	1	0	0	0
Treatment Period	Study drug toxicity	1	1	3	3	0	9	7	1	0	5	2	3	7	5	12	0	3	3	12	15	4	7	4

Baseline characteristics

Characteristic	OC Arm N-I Dose Level 2c:	OC Arm N-I Dose Level 2b:	OC Arm N-I Dose Level 2	BC Arm N-I Dose Level 2b	BC Arm N-I Dose Level 2	BC Arm N	SCLC Arm N-I Dose Level 2b	SCLC Arm N-I Dose Level 1 -	SCLC Arm N-I Dose Level 2- Expansion	SCLC Arm N Expansion	SCLC Arm N-I Dose Level 2 - Pre-expansion	SCLC Arm N - Pre-expansion	PC Arm N-I Dose Level 2d	PC Arm N-I Dose Level 2	PC Arm N-I Dose Level 1	PC Arm N	GC Arm N-I Dose Level 2b	GC Arm N-I Dose Level 2	GC Arm N-I Dose Level 1	GC Arm N	TNBC Arm N-I Dose Level 2	TNBC Arm N-I Dose Level 1	TNBC Arm N	Total
Age, Continuous	58.7 Years STANDARD_DEVIATION 12.2	59.6 Years STANDARD_DEVIATION 10.9	56.7 Years STANDARD_DEVIATION 11.1	64.1 Years STANDARD_DEVIATION 9.69	63.9 Years STANDARD_DEVIATION 9.54	64.1 Years STANDARD_DEVIATION 10.86	60.1 Years STANDARD_DEVIATION 7.74	59.3 Years STANDARD_DEVIATION 6.7	63.7 Years STANDARD_DEVIATION 9.06	62.8 Years STANDARD_DEVIATION 9.09	63.9 Years STANDARD_DEVIATION 9.94	62.6 Years STANDARD_DEVIATION 8.5	62.1 Years STANDARD_DEVIATION 11.51	64.1 Years STANDARD_DEVIATION 9.21	58.3 Years STANDARD_DEVIATION 9.87	63.2 Years STANDARD_DEVIATION 9.7	56.4 Years STANDARD_DEVIATION 13.4	53.2 Years STANDARD_DEVIATION 12.58	67.0 Years STANDARD_DEVIATION 9.54	57.2 Years STANDARD_DEVIATION 10.99	49.1 Years STANDARD_DEVIATION 9	52.7 Years STANDARD_DEVIATION 9.5	53.3 Years STANDARD_DEVIATION 11.9	61.2 Years STANDARD_DEVIATION 10.7
Age, Customized < 65	25 Participants	26 Participants	30 Participants	57 Participants	47 Participants	37 Participants	38 Participants	2 Participants	47 Participants	82 Participants	27 Participants	55 Participants	13 Participants	9 Participants	2 Participants	5 Participants	35 Participants	39 Participants	1 Participants	42 Participants	18 Participants	3 Participants	16 Participants	656 Participants
Age, Customized >= 65	17 Participants	17 Participants	11 Participants	47 Participants	45 Participants	41 Participants	17 Participants	1 Participants	49 Participants	65 Participants	34 Participants	43 Participants	17 Participants	9 Participants	1 Participants	13 Participants	17 Participants	10 Participants	2 Participants	17 Participants	0 Participants	0 Participants	2 Participants	475 Participants
Age, Customized >= 65 and < 75	12 Participants	14 Participants	10 Participants	29 Participants	34 Participants	31 Participants	17 Participants	1 Participants	39 Participants	51 Participants	27 Participants	34 Participants	14 Participants	7 Participants	1 Participants	12 Participants	12 Participants	8 Participants	1 Participants	15 Participants	0 Participants	0 Participants	1 Participants	370 Participants
Age, Customized >= 75	5 Participants	3 Participants	1 Participants	18 Participants	11 Participants	10 Participants	0 Participants	0 Participants	10 Participants	14 Participants	7 Participants	9 Participants	3 Participants	2 Participants	0 Participants	1 Participants	5 Participants	2 Participants	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants	105 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	1 Participants	1 Participants	4 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants	29 Participants	26 Participants	73 Participants	38 Participants	59 Participants	26 Participants	2 Participants	55 Participants	97 Participants	47 Participants	63 Participants	28 Participants	13 Participants	3 Participants	16 Participants	35 Participants	29 Participants	2 Participants	41 Participants	9 Participants	3 Participants	10 Participants	736 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants	13 Participants	14 Participants	27 Participants	54 Participants	17 Participants	28 Participants	1 Participants	41 Participants	50 Participants	14 Participants	32 Participants	2 Participants	4 Participants	0 Participants	2 Participants	15 Participants	19 Participants	1 Participants	17 Participants	9 Participants	0 Participants	8 Participants	377 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants	2 Participants	4 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	18 Participants
Race (NIH/OMB) Black or African American	2 Participants	0 Participants	1 Participants	4 Participants	3 Participants	4 Participants	0 Participants	1 Participants	5 Participants	7 Participants	1 Participants	3 Participants	4 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	3 Participants	1 Participants	0 Participants	3 Participants	46 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants	6 Participants	1 Participants	1 Participants	1 Participants	0 Participants	3 Participants	4 Participants	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	24 Participants
Race (NIH/OMB) White	38 Participants	43 Participants	37 Participants	90 Participants	87 Participants	72 Participants	54 Participants	2 Participants	87 Participants	134 Participants	60 Participants	91 Participants	23 Participants	16 Participants	3 Participants	16 Participants	50 Participants	46 Participants	3 Participants	56 Participants	17 Participants	3 Participants	14 Participants	1042 Participants
Sex: Female, Male Female	42 Participants	43 Participants	41 Participants	23 Participants	18 Participants	24 Participants	23 Participants	1 Participants	35 Participants	61 Participants	26 Participants	37 Participants	12 Participants	8 Participants	2 Participants	5 Participants	7 Participants	15 Participants	1 Participants	14 Participants	18 Participants	3 Participants	18 Participants	477 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	81 Participants	74 Participants	54 Participants	32 Participants	2 Participants	61 Participants	86 Participants	35 Participants	61 Participants	18 Participants	10 Participants	1 Participants	13 Participants	45 Participants	34 Participants	2 Participants	45 Participants	0 Participants	0 Participants	0 Participants	654 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk	EG014 affected / at risk	EG015 affected / at risk	EG016 affected / at risk	EG017 affected / at risk	EG018 affected / at risk	EG019 affected / at risk	EG020 affected / at risk
deaths Total, all-cause mortality	17 / 18	3 / 3	18 / 18	53 / 59	3 / 3	42 / 49	50 / 52	18 / 18	3 / 3	18 / 18	24 / 30	212 / 245	136 / 157	3 / 3	45 / 55	60 / 78	54 / 92	82 / 104	33 / 41	37 / 43	34 / 42
other Total, other adverse events	18 / 18	3 / 3	17 / 18	58 / 59	3 / 3	47 / 49	49 / 52	18 / 18	3 / 3	17 / 18	29 / 30	226 / 245	147 / 157	3 / 3	53 / 55	77 / 78	85 / 92	100 / 104	38 / 41	40 / 43	41 / 42
serious Total, serious adverse events	9 / 18	2 / 3	11 / 18	32 / 59	1 / 3	37 / 49	34 / 52	10 / 18	3 / 3	11 / 18	16 / 30	129 / 245	111 / 157	2 / 3	32 / 55	41 / 78	62 / 92	72 / 104	24 / 41	31 / 43	29 / 42

Outcome results

Primary

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

Population: All Treated Participants

Arm	Measure	Value (NUMBER)
TNBC Arm N	Objective Response Rate ( ORR )	5.6 Percentage of Participants
TNBC Arm N-I Dose Level 1	Objective Response Rate ( ORR )	0.0 Percentage of Participants
TNBC Arm N-I Dose Level 2	Objective Response Rate ( ORR )	0.0 Percentage of Participants
GC Arm N	Objective Response Rate ( ORR )	11.9 Percentage of Participants
GC Arm N-I Dose Level 1	Objective Response Rate ( ORR )	0.0 Percentage of Participants
GC Arm N-I Dose Level 2	Objective Response Rate ( ORR )	24.5 Percentage of Participants
GC Arm N-I Dose Level 2b	Objective Response Rate ( ORR )	7.7 Percentage of Participants
PC Arm N	Objective Response Rate ( ORR )	0.0 Percentage of Participants
PC Arm N-I Dose Level 1	Objective Response Rate ( ORR )	0.0 Percentage of Participants
PC Arm N-I Dose Level 2	Objective Response Rate ( ORR )	0.0 Percentage of Participants
PC Arm N-I Dose Level 2d	Objective Response Rate ( ORR )	6.7 Percentage of Participants
SCLC Arm N - Pre-expansion	Objective Response Rate ( ORR )	13.3 Percentage of Participants
SCLC Arm N-I Dose Level 2 - Pre-expansion	Objective Response Rate ( ORR )	26.2 Percentage of Participants
SCLC Arm N Expansion	Objective Response Rate ( ORR )	11.6 Percentage of Participants
SCLC Arm N-I Dose Level 2- Expansion	Objective Response Rate ( ORR )	21.9 Percentage of Participants
SCLC Arm N-I Dose Level 1 -	Objective Response Rate ( ORR )	33.3 Percentage of Participants
SCLC Arm N-I Dose Level 2b	Objective Response Rate ( ORR )	18.2 Percentage of Participants
SCLC Arm N- All Treated	Objective Response Rate ( ORR )	11.8 Percentage of Participants
SCLC Arm N-I Dose Level 2 - All Treated	Objective Response Rate ( ORR )	22.3 Percentage of Participants
BC Arm N	Objective Response Rate ( ORR )	25.6 Percentage of Participants
BC Arm N-I Dose Level 2	Objective Response Rate ( ORR )	38.0 Percentage of Participants
BC Arm N-I Dose Level 2b	Objective Response Rate ( ORR )	26.9 Percentage of Participants
OC Arm N-I Dose Level 2	Objective Response Rate ( ORR )	12.2 Percentage of Participants
OC Arm N-I Dose Level 2b:	Objective Response Rate ( ORR )	7.0 Percentage of Participants
OC Arm N-I Dose Level 2c:	Objective Response Rate ( ORR )	9.5 Percentage of Participants

Comparison: SCLC Arm N Expansion as compare to SCLC Arm N-I Dose Level 2- Expansionp-value: 0.030995% CI: [1.06, 4.26]Cochran-Mantel-Haenszel

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

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Objective Response Rate ( ORR )