Brief Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in combination with nivolumab in patients with relapsed/refractory SCLC.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

106

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Nov 2014

Longer than P75 for phase_1

Geographic Reach

7 countries

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.1 years study duration

First Submitted

Initial submission to the registry

September 19, 2014

Completed

6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed

2 months until next milestone

Study Start

First participant enrolled

November 14, 2014

Completed

8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2022

Completed

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

March 5, 2024

Completed

Last Updated

March 5, 2024

Status Verified

February 1, 2024

Enrollment Period

8.1 years

First QC Date

September 19, 2014

Results QC Date

December 19, 2023

Last Update Submit

February 9, 2024

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (5)

Number of Participants With Adverse Events (AEs)
Number of participants with any grade adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From first dose to 100 days post last dose (Up to 64 months)
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with any grade serious adverse events (SAEs). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * results in death * is life-threatening * requires inpatient hospitalization or causes prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From first dose to 100 days post last dose (Up to 64 months)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Number of participants with any grade adverse events (AEs) leading to discontinuation. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From first dose to 100 days post last dose (Up to 64 months)
Number of Participants Who Died
Number of participants who died due to any cause.
From first dose to 100 days post last dose (Up to 64 months)
Number of Participants With Abnormal Hepatic Test
Number of participants with laboratory abnormalities in specific hepatic tests. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: * ALT or AST \> 5xULN, \> 3xULN, and \> 2xULN * Any of ALT, AST, Total Bilirubin or ALP \> 8xULN * Total bilirubin \> 3xULN ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; ULN = Upper Limit of Normal
From first dose to 100 days post last dose (Up to 64 months)

Secondary Outcomes (18)

BMS-986012 Maximum Observed Serum Concentration (Cmax)
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
BMS-986012 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
+13 more secondary outcomes