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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02598960




Registration number
NCT02598960
Ethics application status
Date submitted
21/10/2015
Date registered
6/11/2015
Date last updated
27/01/2020

Titles & IDs
Public title
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.
Scientific 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
Secondary ID [1] 0 0
2015-002505-11
Secondary ID [2] 0 0
CA009-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986156
Treatment: Drugs - Nivolumab

Experimental: BMS-986156: Dose Escalation -

Experimental: BMS-986156 + nivolumab (nivo): Dose Escalation -

Experimental: BMS-986156: Dose Expansion -

Experimental: BMS-986156 + nivolumab (nivo): Dose Expansion -

Experimental: BMS986156 + Nivo: Cohort Expansion -


Treatment: Drugs: BMS-986156


Treatment: Drugs: Nivolumab


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events
Timepoint [1] 0 0
Up to 30 days after the last dose of study drug
Primary outcome [2] 0 0
Incidence of Serious Adverse Events
Timepoint [2] 0 0
Up to 30 days after the last dose of study drug
Primary outcome [3] 0 0
Incidence of Adverse Events leading to discontinuation
Timepoint [3] 0 0
Up to 30 days after the last dose of study drug
Primary outcome [4] 0 0
Incidence of Death
Timepoint [4] 0 0
Up to 30 days after the last dose of study drug
Primary outcome [5] 0 0
Incidence of Clinical Laboratory Abnormalities
Timepoint [5] 0 0
Up to 30 days after the last dose of study drug
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Progression free survival rate (PFSR)
Timepoint [2] 0 0
At week 24
Secondary outcome [3] 0 0
Duration of response
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Maximum observed concentration (Cmax) of BMS-986156
Timepoint [4] 0 0
Day 1 to 56 days
Secondary outcome [5] 0 0
Time of maximum observed concentration (Tmax) of BMS-986156
Timepoint [5] 0 0
Day 1 to 56 days
Secondary outcome [6] 0 0
Area under the concentration-time curve in one dosing interval (AUC [TAU]) of BMS-986156
Timepoint [6] 0 0
Day 1 to 56 days
Secondary outcome [7] 0 0
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T) of BMS-986156
Timepoint [7] 0 0
Day 1 to 56 days
Secondary outcome [8] 0 0
Anti-drug antibody (ADA) response to BMS-986156
Timepoint [8] 0 0
Day 1 to 56 days
Secondary outcome [9] 0 0
Anti-drug antibody response to BMS-986156 and Nivolumab
Timepoint [9] 0 0
Day 1 to 56 days
Secondary outcome [10] 0 0
Best Overall Response(ORR)
Timepoint [10] 0 0
Approximately 3 years

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Liverpool Cancer Therapy Center - Liverpool
Recruitment hospital [2] 0 0
Local Institution - Westmead
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
France
State/province [11] 0 0
Paris Cedex 5
Country [12] 0 0
France
State/province [12] 0 0
Toulouse Cedex 9
Country [13] 0 0
France
State/province [13] 0 0
Vlllejuif
Country [14] 0 0
Germany
State/province [14] 0 0
Bonn
Country [15] 0 0
Germany
State/province [15] 0 0
Freiburg
Country [16] 0 0
Germany
State/province [16] 0 0
Wuerzburg
Country [17] 0 0
Italy
State/province [17] 0 0
Milano
Country [18] 0 0
Italy
State/province [18] 0 0
Milan
Country [19] 0 0
Netherlands
State/province [19] 0 0
Amsterdam
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Switzerland
State/province [21] 0 0
St. Gallen
Country [22] 0 0
Switzerland
State/province [22] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02598960
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications