An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.

Solid Tumors Clinical Trial

Official title:

A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598960
• Other study ID #: CA009-002
• Secondary ID: 2015-002505-11
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 14, 2015
• Est. completion date: December 16, 2019

Study information

• Verified date: February 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Inclusion Criteria:

• For Dose Escalation:
• Subjects with any previously treated advanced (metastatic or refractory) solid tumor
• For Cohort Expansion:
• Subjects must have a previously treated advanced solid tumor to be eligible
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
• Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men

Exclusion Criteria:

• Known central nervous system metastases or central nervous system as the only source of disease
• Other concomitant malignancies (with some exceptions per protocol)
• Active, known or suspected autoimmune disease
• Uncontrolled or significant cardiovascular disease
• History of active or chronic hepatitis (e.g. Hep B or C)
• Impaired liver or bone marrow function
• Major surgery less than 1 month before start of the study

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• BMS-986156

• Nivolumab

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Liverpool Cancer Therapy Center	Liverpool	New South Wales
Australia	Linear Clinical Research Ltd	Nedlands	Western Australia
Australia	Local Institution	Westmead	New South Wales
Belgium	Local Institution - 0012	Gent
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Toronto	Ontario
France	Local Institution	Paris Cedex 5
France	Institut Claudius Regaud	Toulouse Cedex 9
France	Institut Gustave Roussy	Vlllejuif
Germany	Local Institution	Bonn
Germany	Local Institution	Freiburg
Germany	Local Institution	Wuerzburg
Italy	Local Institution - 0015	Milan	Lombardia
Italy	Local Institution - 0014	Milano
Netherlands	Local Institution	Amsterdam
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Switzerland	Cantonal Hospital St. Gallen	St. Gallen
Switzerland	Local Institution	Zurich
United States	Emory University	Atlanta	Georgia
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	The Ohio State University	Columbus	Ohio
United States	The West Clinic, P.C.	Germantown	Tennessee
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths	Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths.; AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.	From first treatment to 100 days post last dose. Approximately 29 months
Primary	Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests	Number of Participants with laboratory abnormalities in specific thyroid tests.; TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number	From first treatment to 100 days post last dose. Approximately 29 months
Primary	Number of Participants With Laboratory Abnormalities in Specific Liver Tests	Number of Participants with laboratory abnormalities in specific liver tests.; ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase	From first treatment to 100 days post last dose. Approximately 29 months
Secondary	Best Overall Response	BOR will be defined by CR, PR, PD and SD; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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 sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.	From first dose to a response or progressive disease (Approximately 50 Months)
Secondary	Overall Response Rate	Defined as the percentage of all treated participants whose BOR is either a complete response(CR) or partial response(PR).; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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.	From first dose to CR and PR (Approximately 50 Months)
Secondary	Progression Free Survival (PFS)	The time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.; Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).	From first dose to disease progression (Approximately 50 Months)
Secondary	Duration of Response	All treated participants with a BOR of CR or PR, is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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.	From first dose to disease progression after a response (Approximately 50 Months)
Secondary	Number of Participants With Anti-Drug Antibody Response	Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab	At Cycle 3 Day 1; where each treatment cycle was 8 weeks

External Links

•   BMS Clinical Trial Information
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