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.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02598960
• Date of registration: 21/10/2015
• Prospective Registration: No
• Primary sponsor: Bristol-Myers Squibb
• 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
• Date of first enrolment: October 9, 2015
• Target sample size: 331
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02598960
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

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

Contacts

• Name: Bristol Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Solid Tumors

Intervention(s)

Drug: Nivolumab

Drug: BMS-986156

Primary Outcome(s)

Incidence of Clinical Laboratory Abnormalities [Time Frame: Up to 30 days after the last dose of study drug]

Incidence of Death [Time Frame: Up to 30 days after the last dose of study drug]

Incidence of Adverse Events leading to discontinuation [Time Frame: Up to 30 days after the last dose of study drug]

Incidence of Serious Adverse Events [Time Frame: Up to 30 days after the last dose of study drug]

Incidence of Adverse Events [Time Frame: Up to 30 days after the last dose of study drug]

Secondary Outcome(s)

Maximum observed concentration (Cmax) of BMS-986156 [Time Frame: Day 1 to 56 days]

Area under the concentration-time curve in one dosing interval (AUC [TAU]) of BMS-986156 [Time Frame: Day 1 to 56 days]

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T) of BMS-986156 [Time Frame: Day 1 to 56 days]

Duration of response [Time Frame: Approximately 3 years]

Progression free survival rate (PFSR) [Time Frame: At week 24]

Anti-drug antibody response to BMS-986156 and Nivolumab [Time Frame: Day 1 to 56 days]

Best Overall Response(ORR) [Time Frame: Approximately 3 years]

Objective response rate (ORR) [Time Frame: Approximately 3 years]

Time of maximum observed concentration (Tmax) of BMS-986156 [Time Frame: Day 1 to 56 days]

Anti-drug antibody (ADA) response to BMS-986156 [Time Frame: Day 1 to 56 days]

Secondary ID(s)

CA009-002

2015-002505-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors