NCT02341625 is a Phase 1, PHASE2 clinical trial of BMS-986148 in Advanced Cancer, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT02341625?

NCT02341625 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT02341625?

Interventions in NCT02341625: BMS-986148, Nivolumab.

What condition does NCT02341625 study?

NCT02341625 studies Advanced Cancer.

Is NCT02341625 still recruiting?

NCT02341625 is currently terminated. Last updated 18 August 2022.

Are results published for NCT02341625?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-08-18 · How we verify

NCT02341625

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of BMS-986148 in Patients With Select Advanced Solid Tumors

Terminated Phase 1, PHASE2 Results posted Last updated 18 August 2022

What this trial tests

Phase 1, PHASE2 trial testing BMS-986148 in Advanced Cancer in 126 participants. Terminated before completion.

Timeline

19 June 2015

Primary endpoint
25 February 2019

7 May 2020

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	19 June 2015
Primary completion	25 February 2019
Estimated completion	7 May 2020
Sites	17 locations across Italy, Netherlands, Belgium, United Kingdom, Canada, Australia, United States

Drugs / interventions tested

BMS-986148 — full drug profile →
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Advanced Cancer — all drugs for Advanced Cancer →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events at Worst CTC Grade Primary · From first dose to up to 100 days post last dose (Up to 6 months)

Number of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen.

Adverse Events (AEs)

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	1
BMS-986148 0.2MG/KG Q3W	2
BMS-986148 0.4MG/KG Q3W	3
BMS-986148 0.8MG/KG Q3W	8
BMS-986148 1.6MG/KG Q3W	10
BMS-986148 1.2MG/KG Q3W Es	59
BMS-986148 0.4MG/KG QW	8
BMS-986148 0.6MG/KG QW	4
BMS-986148 0.8MG/KG Q3W+Nivolumab	30

Serious Adverse Events (SAEs)

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	1
BMS-986148 0.2MG/KG Q3W	1
BMS-986148 0.4MG/KG Q3W	1
BMS-986148 0.8MG/KG Q3W	5
BMS-986148 1.6MG/KG Q3W	4
BMS-986148 1.2MG/KG Q3W Es	32
BMS-986148 0.4MG/KG QW	6
BMS-986148 0.6MG/KG QW	3
BMS-986148 0.8MG/KG Q3W+Nivolumab	21

AEs Leading to Discontinuation

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0
BMS-986148 0.2MG/KG Q3W	0
BMS-986148 0.4MG/KG Q3W	0
BMS-986148 0.8MG/KG Q3W	1
BMS-986148 1.6MG/KG Q3W	3
BMS-986148 1.2MG/KG Q3W Es	11
BMS-986148 0.4MG/KG QW	1
BMS-986148 0.6MG/KG QW	0
BMS-986148 0.8MG/KG Q3W+Nivolumab	7

Deaths

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	1
BMS-986148 0.2MG/KG Q3W	2
BMS-986148 0.4MG/KG Q3W	3
BMS-986148 0.8MG/KG Q3W	5
BMS-986148 1.6MG/KG Q3W	7
BMS-986148 1.2MG/KG Q3W Es	38
BMS-986148 0.4MG/KG QW	7
BMS-986148 0.6MG/KG QW	4
BMS-986148 0.8MG/KG Q3W+Nivolumab	22

Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Primary · From first dose to up to 100 days post last dose (Up to 6 months)

Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03.

Hemoglobin increase from baseline

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	1
BMS-986148 0.2MG/KG Q3W	1
BMS-986148 0.4MG/KG Q3W	0
BMS-986148 0.8MG/KG Q3W	3
BMS-986148 1.6MG/KG Q3W	3
BMS-986148 1.2MG/KG Q3W Es	20
BMS-986148 0.4MG/KG QW	2
BMS-986148 0.6MG/KG QW	1
BMS-986148 0.8MG/KG Q3W+Nivolumab	12

Hemoglobin decrease from baseline

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0
BMS-986148 0.2MG/KG Q3W	0
BMS-986148 0.4MG/KG Q3W	1
BMS-986148 0.8MG/KG Q3W	1
BMS-986148 1.6MG/KG Q3W	0
BMS-986148 1.2MG/KG Q3W Es	3
BMS-986148 0.4MG/KG QW	0
BMS-986148 0.6MG/KG QW	0
BMS-986148 0.8MG/KG Q3W+Nivolumab	0

Platelet Count increase from baseline

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0
BMS-986148 0.2MG/KG Q3W	0
BMS-986148 0.4MG/KG Q3W	0
BMS-986148 0.8MG/KG Q3W	3
BMS-986148 1.6MG/KG Q3W	4
BMS-986148 1.2MG/KG Q3W Es	14
BMS-986148 0.4MG/KG QW	0
BMS-986148 0.6MG/KG QW	1
BMS-986148 0.8MG/KG Q3W+Nivolumab	6

Platelet Count decrease from baseline

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0
BMS-986148 0.2MG/KG Q3W	0
BMS-986148 0.4MG/KG Q3W	0
BMS-986148 0.8MG/KG Q3W	0
BMS-986148 1.6MG/KG Q3W	0
BMS-986148 1.2MG/KG Q3W Es	0
BMS-986148 0.4MG/KG QW	0
BMS-986148 0.6MG/KG QW	0
BMS-986148 0.8MG/KG Q3W+Nivolumab	0

Leukocytes increase from baseline

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0
BMS-986148 0.2MG/KG Q3W	0
BMS-986148 0.4MG/KG Q3W	1
BMS-986148 0.8MG/KG Q3W	0
BMS-986148 1.6MG/KG Q3W	2
BMS-986148 1.2MG/KG Q3W Es	1
BMS-986148 0.4MG/KG QW	1
BMS-986148 0.6MG/KG QW	0
BMS-986148 0.8MG/KG Q3W+Nivolumab	2

Leukocytes decrease from baseline

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0
BMS-986148 0.2MG/KG Q3W	0
BMS-986148 0.4MG/KG Q3W	0
BMS-986148 0.8MG/KG Q3W	0
BMS-986148 1.6MG/KG Q3W	0
BMS-986148 1.2MG/KG Q3W Es	1
BMS-986148 0.4MG/KG QW	1
BMS-986148 0.6MG/KG QW	0
BMS-986148 0.8MG/KG Q3W+Nivolumab	0

Neutrophils increase from baseline

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0
BMS-986148 0.2MG/KG Q3W	0
BMS-986148 0.4MG/KG Q3W	0
BMS-986148 0.8MG/KG Q3W	0
BMS-986148 1.6MG/KG Q3W	1
BMS-986148 1.2MG/KG Q3W Es	3
BMS-986148 0.4MG/KG QW	0
BMS-986148 0.6MG/KG QW	0
BMS-986148 0.8MG/KG Q3W+Nivolumab	1

Neutrophils decrease from baseline

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0
BMS-986148 0.2MG/KG Q3W	0
BMS-986148 0.4MG/KG Q3W	0
BMS-986148 0.8MG/KG Q3W	0
BMS-986148 1.6MG/KG Q3W	0
BMS-986148 1.2MG/KG Q3W Es	1
BMS-986148 0.4MG/KG QW	0
BMS-986148 0.6MG/KG QW	0
BMS-986148 0.8MG/KG Q3W+Nivolumab	0

Maximum Observed Serum Concentration (Cmax) Secondary · PK blood assessed on cycle 1, day 1

Maximum observed serum concentration (Cmax) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.

Total Antibody

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	2.3	± 31.4
BMS-986148 0.2MG/KG Q3W	2.8	± 7.6
BMS-986148 0.4MG/KG Q3W	3.3	± 76.7
BMS-986148 0.8MG/KG Q3W	16.4	± 47.2
BMS-986148 1.6MG/KG Q3W	39.8	± 24.5
BMS-986148 1.2MG/KG Q3W Es	28.5	± 14.0
BMS 1.2MG/KG Q3W Ex	28.3	± 22.5
BMS-986148 0.4MG/KG QW	9.3	± 21.3
BMS-986148 0.6MG/KG QW	14.5	± 22.3
BMS 0.8MG/KG Q3W+Nivolumab Es	16.7	± 19.7
BMS 0.8MG/KG Q3W+Nivolumab Ex	18.8	± 22.4

Active Antibody-Drug Conjugate (ADC)

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	2.0	± 29.8
BMS-986148 0.2MG/KG Q3W	2.2	± 8.2
BMS-986148 0.4MG/KG Q3W	2.6	± 76.1
BMS-986148 0.8MG/KG Q3W	15.8	± 46.4
BMS-986148 1.6MG/KG Q3W	40.0	± 26.3
BMS-986148 1.2MG/KG Q3W Es	27.0	± 18.6
BMS 1.2MG/KG Q3W Ex	27.5	± 22.6
BMS-986148 0.4MG/KG QW	8.8	± 20.3
BMS-986148 0.6MG/KG QW	13.6	± 31.0
BMS 0.8MG/KG Q3W+Nivolumab Es	15.3	± 27.6
BMS 0.8MG/KG Q3W+Nivolumab Ex	17.8	± 24.6

Unconjugated Tubulysin

Group	Value	95% CI
BMS-986148 0.4MG/KG Q3W	0.5	± NA
BMS-986148 0.8MG/KG Q3W	0.2	± 17.1
BMS-986148 1.6MG/KG Q3W	0.4	± 52.3
BMS-986148 1.2MG/KG Q3W Es	0.4	± 70.9
BMS 1.2MG/KG Q3W Ex	0.3	± 58.2
BMS-986148 0.4MG/KG QW	0.1	± 36.0
BMS-986148 0.6MG/KG QW	0.4	± 75.0
BMS 0.8MG/KG Q3W+Nivolumab Es	0.2	± 42.5
BMS 0.8MG/KG Q3W+Nivolumab Ex	0.2	± 42.5

Time of Maximum Observed Serum Concentration (Tmax) Secondary · PK blood assessed on cycle 1, day 1

Time of maximum observed serum concentration (Tmax) of BMS-986148 grouped by dose + dose regimen.

Total Antibody

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	2.2	0.3 – 4.0
BMS-986148 0.2MG/KG Q3W	2.2	0.3 – 4.1
BMS-986148 0.4MG/KG Q3W	3.9	0.5 – 4.7
BMS-986148 0.8MG/KG Q3W	4.0	0.2 – 4.8
BMS-986148 1.6MG/KG Q3W	3.9	0.9 – 4.3
BMS-986148 1.2MG/KG Q3W Es	4.1	1.1 – 4.1
BMS 1.2MG/KG Q3W Ex	4.0	0.8 – 24.1
BMS-986148 0.4MG/KG QW	4.0	0.6 – 4.1
BMS-986148 0.6MG/KG QW	3.8	1.1 – 3.9
BMS 0.8MG/KG Q3W+Nivolumab Es	1.1	0.6 – 24.1
BMS 0.8MG/KG Q3W+Nivolumab Ex	4.0	0.9 – 23.8

Active Antibody-Drug Conjugate (ADC)

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0.2	0.1 – 0.3
BMS-986148 0.2MG/KG Q3W	2.2	0.3 – 4.1
BMS-986148 0.4MG/KG Q3W	0.5	0.1 – 3.9
BMS-986148 0.8MG/KG Q3W	2.5	0.2 – 4.0
BMS-986148 1.6MG/KG Q3W	1.5	0.8 – 4.3
BMS-986148 1.2MG/KG Q3W Es	3.8	1.0 – 4.1
BMS 1.2MG/KG Q3W Ex	3.9	0.8 – 4.7
BMS-986148 0.4MG/KG QW	4.0	0.6 – 4.1
BMS-986148 0.6MG/KG QW	3.8	1.1 – 3.9
BMS 0.8MG/KG Q3W+Nivolumab Es	1.0	0.6 – 4.2
BMS 0.8MG/KG Q3W+Nivolumab Ex	4.0	0.9 – 4.0

Unconjugated Tubulysin

Group	Value	95% CI
BMS-986148 0.4MG/KG Q3W	25.5	25.5 – 25.5
BMS-986148 0.8MG/KG Q3W	120.2	71.8 – 169.7
BMS-986148 1.6MG/KG Q3W	167.3	71.4 – 170.0
BMS-986148 1.2MG/KG Q3W Es	168.8	48.0 – 335.5
BMS 1.2MG/KG Q3W Ex	166.1	24.3 – 338.8
BMS-986148 0.4MG/KG QW	168.2	166.9 – 169.4
BMS-986148 0.6MG/KG QW	166.7	94.7 – 238.7
BMS 0.8MG/KG Q3W+Nivolumab Es	165.1	48.0 – 170.9
BMS 0.8MG/KG Q3W+Nivolumab Ex	166.5	47.8 – 335.9

Concentration at the End of a Dosing Interval (Ctau) Secondary · PK blood assessed on cycle 1, day 1

Concentration at the end of a dosing interval (Ctau) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.

Total Antibody

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0.0035	± 112.0
BMS-986148 0.2MG/KG Q3W	0.0333	± 115.7
BMS-986148 0.4MG/KG Q3W	0.8233	± 131.8
BMS-986148 0.8MG/KG Q3W	0.4426	± 106.1
BMS-986148 1.6MG/KG Q3W	1.4101	± 101.8
BMS-986148 1.2MG/KG Q3W Es	1.0917	± 91.9
BMS 1.2MG/KG Q3W Ex	1.1938	± 98.7
BMS-986148 0.4MG/KG QW	3.2035	± 20.2
BMS-986148 0.6MG/KG QW	3.8872	± 46.1
BMS 0.8MG/KG Q3W+Nivolumab Es	0.2133	± 114.0
BMS 0.8MG/KG Q3W+Nivolumab Ex	0.7544	± 83.5

Active Antibody-Drug Conjugate (ADC)

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0.0633	± 141.3
BMS-986148 0.4MG/KG Q3W	0.0058	± NA
BMS-986148 0.8MG/KG Q3W	0.0309	± 123.8
BMS-986148 1.6MG/KG Q3W	0.3049	± 110.0
BMS-986148 1.2MG/KG Q3W Es	0.2121	± 111.3
BMS 1.2MG/KG Q3W Ex	0.1558	± 123.4
BMS-986148 0.4MG/KG QW	1.2705	± 39.5
BMS-986148 0.6MG/KG QW	1.9068	± 59.1
BMS 0.8MG/KG Q3W+Nivolumab Es	0.1119	± 187.1
BMS 0.8MG/KG Q3W+Nivolumab Ex	0.0797	± 103.7

Unconjugated Tubulysin

Group	Value	95% CI
BMS-986148 1.6MG/KG Q3W	0.1630	± 0.9
BMS-986148 1.2MG/KG Q3W Es	0.2590	± 77.1
BMS 1.2MG/KG Q3W Ex	0.1634	± 48.2
BMS-986148 0.4MG/KG QW	0.1388	± 36.0
BMS-986148 0.6MG/KG QW	0.3539	± 75.0
BMS 0.8MG/KG Q3W+Nivolumab Ex	0.1330	± NA

Trough Observed Serum Concentration (Ctrough) Secondary · PK blood assessment include cycle 2-day 1 and cycle 1-day 8

Trough observed serum concentration (Ctrough) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.

Total Antibody

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0.1	± 0.0
BMS-986148 0.2MG/KG Q3W	0.1	± 0.00
BMS-986148 0.4MG/KG Q3W	0.1	± 0.00
BMS-986148 0.8MG/KG Q3W	0.79676	± 92.4
BMS-986148 1.6MG/KG Q3W	0.92146	± 125.9
BMS-986148 1.2MG/KG Q3W Es	1.23291	± 81.7
BMS 1.2MG/KG Q3W Ex	1.14568	± 104.4
BMS-986148 0.4MG/KG QW	3.20352	± 20.2
BMS-986148 0.6MG/KG QW	3.88717	± 46.1
BMS 0.8MG/KG Q3W+Nivolumab Es	0.33875	± 122.1
BMS 0.8MG/KG Q3W+Nivolumab Ex	0.77912	± 79.1

Active Antibody-Drug Conjugate (ADC)

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0.1	± 0.0
BMS-986148 0.2MG/KG Q3W	0.1	± 0.00
BMS-986148 0.4MG/KG Q3W	0.1	± 0.00
BMS-986148 0.8MG/KG Q3W	0.27671	± 95.3
BMS-986148 1.6MG/KG Q3W	0.21835	± 152.7
BMS-986148 1.2MG/KG Q3W Es	0.36894	± 90.7
BMS 1.2MG/KG Q3W Ex	0.31524	± 111.4
BMS-986148 0.4MG/KG QW	1.27047	± 39.5
BMS-986148 0.6MG/KG QW	1.90678	± 59.1
BMS 0.8MG/KG Q3W+Nivolumab Es	0.18096	± 97.4
BMS 0.8MG/KG Q3W+Nivolumab Ex	0.24389	± 81.0

Unconjugated Tubulysin

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	0.00005	± 0.0
BMS-986148 0.2MG/KG Q3W	0.00005	± 0.0
BMS-986148 0.4MG/KG Q3W	0.00005	± 0.0
BMS-986148 0.8MG/KG Q3W	0.00005	± 0.0
BMS-986148 1.6MG/KG Q3W	0.00007	± 66.6
BMS-986148 1.2MG/KG Q3W Es	0.00009	± 127.6
BMS 1.2MG/KG Q3W Ex	0.00006	± 80.7
BMS-986148 0.4MG/KG QW	0.00006	± 64.7
BMS-986148 0.6MG/KG QW	0.00018	± 104.0
BMS 0.8MG/KG Q3W+Nivolumab Es	0.00005	± 0.0
BMS 0.8MG/KG Q3W+Nivolumab Ex	0.00005	± 40.8

Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) Secondary · PK blood assessment include cycle 1-day 1

Area under the concentration-time curve from time Zero to time T (AUC(0-t)) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.

Total Antibody

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	152.6	± 31.6
BMS-986148 0.2MG/KG Q3W	232.5	± 17.5
BMS-986148 0.4MG/KG Q3W	129.6	± 131.3
BMS-986148 0.8MG/KG Q3W	1979.5	± 69.6
BMS-986148 1.6MG/KG Q3W	5399.8	± 40.1
BMS-986148 1.2MG/KG Q3W Es	4285.7	± 29.3
BMS 1.2MG/KG Q3W Ex	3472.6	± 47.1
BMS-986148 0.4MG/KG QW	858.0	± 22.9
BMS-986148 0.6MG/KG QW	1278.8	± 35.1
BMS-986148 0.8MG/KG Q3W+Nivolumab	1815.8	± 43.4
BMS 0.8MG/KG Q3W+Nivolumab Ex	2611.3	± 33.5

Active Antibody-Drug Conjugate (ADC)

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	88.6	± 48.7
BMS-986148 0.2MG/KG Q3W	70.7	± 42.9
BMS-986148 0.4MG/KG Q3W	60.8	± 136.2
BMS-986148 0.8MG/KG Q3W	1042.1	± 68.6
BMS-986148 1.6MG/KG Q3W	3083.6	± 32.3
BMS-986148 1.2MG/KG Q3W Es	2493.1	± 25.1
BMS 1.2MG/KG Q3W Ex	1984.7	± 45.7
BMS-986148 0.4MG/KG QW	565.4	± 30.3
BMS-986148 0.6MG/KG QW	927.3	± 38.7
BMS-986148 0.8MG/KG Q3W+Nivolumab	1059.0	± 44.8
BMS 0.8MG/KG Q3W+Nivolumab Ex	1447.5	± 36.2

Unconjugated Tubulysin

Group	Value	95% CI
BMS-986148 0.4MG/KG Q3W	49.6	± NA
BMS-986148 0.8MG/KG Q3W	29.6	± 42.8
BMS-986148 1.6MG/KG Q3W	80.1	± 73.4
BMS-986148 1.2MG/KG Q3W Es	197.0	± 59.4
BMS 1.2MG/KG Q3W Ex	42.3	± 80.4
BMS-986148 0.4MG/KG QW	9.3	± 73.0
BMS-986148 0.6MG/KG QW	42.5	± 84.3
BMS-986148 0.8MG/KG Q3W+Nivolumab	25.5	± 58.8
BMS 0.8MG/KG Q3W+Nivolumab Ex	17.7	± 110.3

Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) Secondary · PK blood assessment include cycle 1-day 1

Area under the concentration-time curve in one dosing interval (AUC\[TAU\]) of BMS-986148 grouped by dose + dose regimen Note: The geometric CV was not calculated. Arithmetic % CV is reported instead

Total Antibody

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	179.3	± 34.8
BMS-986148 0.2MG/KG Q3W	265.7	± 13.3
BMS-986148 0.4MG/KG Q3W	344.6	± 98.5
BMS-986148 0.8MG/KG Q3W	2059.3	± 68.7
BMS-986148 1.6MG/KG Q3W	5318.6	± 36.9
BMS-986148 1.2MG/KG Q3W Es	4316.1	± 28.8
BMS 1.2MG/KG Q3W Ex	4159.4	± 39.5
BMS-986148 0.4MG/KG QW	858.0	± 22.9
BMS-986148 0.6MG/KG QW	1533.5	± 19.2
BMS 0.8MG/KG Q3W+Nivolumab Es	1839.0	± 45.4
BMS 0.8MG/KG Q3W+Nivolumab Ex	2689.9	± 34.0

Active Antibody-Drug Conjugate (ADC)

Group	Value	95% CI
BMS-986148 0.1MG/KG Q3W	109.0	± 35.2
BMS-986148 0.4MG/KG Q3W	371.6	± NA
BMS-986148 0.8MG/KG Q3W	1098.7	± 67.5
BMS-986148 1.6MG/KG Q3W	3246.0	± 36.6
BMS-986148 1.2MG/KG Q3W Es	2507.2	± 24.7
BMS 1.2MG/KG Q3W Ex	2271.7	± 40.1
BMS-986148 0.4MG/KG QW	565.4	± 30.3
BMS-986148 0.6MG/KG QW	1063.9	± 32.2
BMS 0.8MG/KG Q3W+Nivolumab Es	1094.9	± 48.0
BMS 0.8MG/KG Q3W+Nivolumab Ex	1478.1	± 36.6

Unconjugated Tubulysin

Group	Value	95% CI
BMS-986148 1.6MG/KG Q3W	173.4	± 48.2
BMS-986148 1.2MG/KG Q3W Es	197.0	± 59.4
BMS 1.2MG/KG Q3W Ex	148.9	± 30.3
BMS-986148 0.4MG/KG QW	9.3	± 73.0
BMS-986148 0.6MG/KG QW	42.5	± 84.3
BMS 0.8MG/KG Q3W+Nivolumab Ex	102.4	± NA

Best Overall Response (BOR) Secondary · Up to 58 months

Best overall response is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest s

Complete Response (CR)

Group	Value	95% CI
BMS-986148 Mesothelioma	0
BMS-986148+Nivolumab Mesothelioma	0
BMS-986148 Ovarian	0
BMS-986148+Nivolumab Ovarian	0
BMS-986148 Pancreatic	0
BMS-986148+Nivolumab Pancreatic	0
BMS-986148 NSCLC	0
BMS-986148+Nivolumab NSCLC	0
BMS-986148 Gastric	0
BMS-986148+Nivolumab Gastric	0

Partial Response (PR)

Group	Value	95% CI
BMS-986148 Mesothelioma	1
BMS-986148+Nivolumab Mesothelioma	3
BMS-986148 Ovarian	2
BMS-986148+Nivolumab Ovarian	0
BMS-986148 Pancreatic	0
BMS-986148+Nivolumab Pancreatic	0
BMS-986148 NSCLC	0
BMS-986148+Nivolumab NSCLC	0
BMS-986148 Gastric	0
BMS-986148+Nivolumab Gastric	0

Stable Disease (SD)

Group	Value	95% CI
BMS-986148 Mesothelioma	13
BMS-986148+Nivolumab Mesothelioma	8
BMS-986148 Ovarian	11
BMS-986148+Nivolumab Ovarian	2
BMS-986148 Pancreatic	4
BMS-986148+Nivolumab Pancreatic	1
BMS-986148 NSCLC	1
BMS-986148+Nivolumab NSCLC	1
BMS-986148 Gastric	1
BMS-986148+Nivolumab Gastric	0

Progressive Disease (PD)

Group	Value	95% CI
BMS-986148 Mesothelioma	7
BMS-986148+Nivolumab Mesothelioma	1
BMS-986148 Ovarian	7
BMS-986148+Nivolumab Ovarian	0
BMS-986148 Pancreatic	11
BMS-986148+Nivolumab Pancreatic	2
BMS-986148 NSCLC	2
BMS-986148+Nivolumab NSCLC	1
BMS-986148 Gastric	2
BMS-986148+Nivolumab Gastric	1

Objective Response Rate (ORR) Secondary · Up to 58 months

Objective response rate is defined as the total percentage of participants whose best overall response (BOR) is either a complete response or partial response divided by the total percentage of participants who are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Group	Value	95% CI
BMS-986148 Mesothelioma	4.0	0.1 – 20.4
BMS-986148+Nivolumab Mesothelioma	23.1	5.0 – 53.8
BMS-986148 Ovarian	9.1	1.1 – 29.2
BMS-986148+Nivolumab Ovarian	0	0 – 0
BMS-986148 Pancreatic	0	0 – 0
BMS-986148+Nivolumab Pancreatic	0	0 – 0
BMS-986148 NSCLC	0	0 – 0
BMS-986148+Nivolumab NSCLC	0	0 – 0
BMS-986148 Gastric	0	0 – 0
BMS-986148+Nivolumab Gastric	0	0 – 0

Duration of Response (DoR) Secondary · Up to 58 months

Duration of response is defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).

Group	Value	95% CI
BMS-986148 Mesothelioma	29.7	29.7 – 29.7
BMS-986148+Nivolumab Mesothelioma	8.97	5.1 – 13.3
BMS-986148 Ovarian	NA	3.0 – 20.0

Progression Free Survival (PFS) Secondary · Up to 58 months

Progression Free Survival is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause. Progression is defined with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. Participants who did not progress nor died will be censored on the date of their last tumor assessment. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSC

Group	Value	95% CI
BMS-986148 Mesothelioma	2.56	1.41 – 4.01
BMS-986148+Nivolumab Mesothelioma	5.19	2.56 – 12.06
BMS-986148 Ovarian	2.79	1.28 – 4.17
BMS-986148+Nivolumab Ovarian	NA	NA – NA
BMS-986148 Pancreatic Part 1B	1.64	1.45 – 1.71
BMS-986148 Pancreatic	NA	NA – NA
BMS-986148+Nivolumab Pancreatic	1.66	1.22 – 2.14
BMS-986148 NSCLC	1.49	1.15 – 5.65
BMS-986148+Nivolumab NSCLC	NA	NA – NA
BMS-986148 Gastric	NA	NA – NA
BMS-986148+Nivolumab Gastric	NA	NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose to 100 days post last dose (Up to 6 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BMS-986148 0.1MG/KG Q3W

Serious: 1/2 (50%)

Deaths: 1/2

BMS-986148 0.2MG/KG Q3W

Serious: 1/2 (50%)

Deaths: 2/2

BMS-986148 0.4MG/KG Q3W

Serious: 1/3 (33%)

Deaths: 3/3

BMS-986148 0.8MG/KG Q3W

Serious: 5/8 (63%)

Deaths: 5/8

BMS-986148 1.6MG/KG Q3W

Serious: 4/10 (40%)

Deaths: 7/10

BMS-986148 1.2MG/KG Q3W

Serious: 32/59 (54%)

Deaths: 38/59

BMS-986148 0.4MG/KG QW

Serious: 6/8 (75%)

Deaths: 7/8

BMS-986148 0.6MG/KG QW

Serious: 3/4 (75%)

Deaths: 4/4

BMS-986148 0.8MG/KG Q3W+Nivolumab

Serious: 21/30 (70%)

Deaths: 22/30

Serious adverse events (73 terms)

Reaction	System	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.6MG/KG Q3W	BMS-986148 1.2MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS-986148 0.8MG/KG Q3W+Ni…
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pericarditis	Cardiac disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Drug-induced liver injury	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—
Transaminases increased	Investigations	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—
Atrial flutter	Cardiac disorders	—	—	—	—	—	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—	—	—	—	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Duodenal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Gastrointestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Ileus paralytic	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Impaired gastric emptying	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Intestinal perforation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—

Other adverse events (158 terms — click to expand)

Reaction	System	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.6MG/KG Q3W	BMS-986148 1.2MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS-986148 0.8MG/KG Q3W+Ni…
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Malignant neoplasm progression, Pneumonia, Abdominal pain, Ascites, Pericarditis, Vomiting, Drug-induced liver injury, Transaminases increased.

Data from ClinicalTrials.gov NCT02341625 adverse events section.

Sponsor's own description

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Antibody-drug conjugates for cancer therapy.
Thomas A, Teicher BA, Hassan R. · · 2016 · cited 436× · PMID 27299281 · DOI 10.1016/s1470-2045(16)30030-4
Antibody-drug conjugates in solid tumors: a look into novel targets.
Criscitiello C, Morganti S, Curigliano G. · · 2021 · cited 169× · PMID 33509252 · DOI 10.1186/s13045-021-01035-z
Targeting cancer with antibody-drug conjugates: Promises and challenges.
Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427
Antibody structure and engineering considerations for the design and function of Antibody Drug Conjugates (ADCs).
Hoffmann RM, Coumbe BGT, Josephs DH, Mele S, et al · · 2018 · cited 134× · PMID 29375935 · DOI 10.1080/2162402x.2017.1395127
Mesothelin as a biomarker for targeted therapy.
Lv J, Li P, Li P. · · 2019 · cited 101× · PMID 31463062 · DOI 10.1186/s40364-019-0169-8
Exploration of the antibody-drug conjugate clinical landscape.
Maecker H, Jonnalagadda V, Bhakta S, Jammalamadaka V, et al · · 2023 · cited 90× · PMID 37639687 · DOI 10.1080/19420862.2023.2229101
Scientific Advances and New Frontiers in Mesothelioma Therapeutics.
Mutti L, Peikert T, Robinson BWS, Scherpereel A, et al · · 2018 · cited 85× · PMID 29966799 · DOI 10.1016/j.jtho.2018.06.011
Emerging therapeutic targets in metastatic progression: A focus on breast cancer.
Li Z, Kang Y. · · 2016 · cited 51× · PMID 27000769 · DOI 10.1016/j.pharmthera.2016.03.003

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02341625 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 18 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02341625.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02341625

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (73 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of BMS-986148

Other recruiting trials for Advanced Cancer

Other Bristol-Myers Squibb trials

Verify against primary sources