CA017-003: A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab anti-PD-1 Monoclonal Antibody) and in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

CA017-003: A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab anti-PD-1 Monoclonal Antibody) and in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Gender
Minimum Age
Adults
Maximum Age
Adults
Physicians
Alese, Olatunji (Tunji)
Phases
I
Drugs
Nivolumab (1215) BMS-986205 (1360)
Disease Sites
N/A
Locations
Winship Cancer Institute of Emory University
NCT ID
NCT02658890
Protocol Number
CA017-003
Contact
If interested in learning more about this clinical trial, please contact winshipcto@emory.edu or (404) 778-1868.

Title

CA017-003: A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab anti-PD-1 Monoclonal Antibody) and in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Summary

Primary Objective:

-To determine the safety, tolerability, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD)/maximum administered dose (MAD)/alternate dose of BMS-986205 administered as monotherapy and in combination with nivolumab in subjects with advanced malignant tumors.

Secondary Objectives:

-To characterize the pharmacokinetics (PK) of BMS-986205 administered alone and in combination with nivolumab.

-To characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab.

-To characterize the immunogenicity of nivolumab when administered in combination with BMS-986205.

-To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors.

Exploratory Objectives:

-To explore potential associations between anti-tumor activity and select biomarker measures in tumor biopsy specimens and peripheral blood prior to treatment and following administration of BMS-986205 in combinations with nivolumab.

-To explore potential relationships between BMS-986205 exposure, anti-tumor activity, pharmacodynamic effects, and key safety measures.

-To characterize the PK of select BMS-986205 metabolites.

-To assess the potential effect of BMS-986205 monotherapy on levels of 4â-hydroxycholesterol, an endogenous marker for cytochrome P450 (CYP) 3A activity.

-To assess the effect of food on the PK of BMS-986205.

-To characterize the PK of nivolumab when administered in combination with BMS-986205.

-To assess the overall survival in subjects treated with BMS-986205 in combination with nivolumab.

-To characterize DLT profile of BMS-986205 alone or in combination with nivolumab

Detail

Primary Objective:

-To determine the safety, tolerability, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD)/maximum administered dose (MAD)/alternate dose of BMS-986205 administered as monotherapy and in combination with nivolumab in subjects with advanced malignant tumors.

Secondary Objectives:

-To characterize the pharmacokinetics (PK) of BMS-986205 administered alone and in combination with nivolumab.

-To characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab.

-To characterize the immunogenicity of nivolumab when administered in combination with BMS-986205.

-To investigate the preliminary anti-tumor activity of BMS-986205 administered in combination with nivolumab in advanced malignant tumors.

Exploratory Objectives:

-To explore potential associations between anti-tumor activity and select biomarker measures in tumor biopsy specimens and peripheral blood prior to treatment and following administration of BMS-986205 in combinations with nivolumab.

-To explore potential relationships between BMS-986205 exposure, anti-tumor activity, pharmacodynamic effects, and key safety measures.

-To characterize the PK of select BMS-986205 metabolites.

-To assess the potential effect of BMS-986205 monotherapy on levels of 4â-hydroxycholesterol, an endogenous marker for cytochrome P450 (CYP) 3A activity.

-To assess the effect of food on the PK of BMS-986205.

-To characterize the PK of nivolumab when administered in combination with BMS-986205.

-To assess the overall survival in subjects treated with BMS-986205 in combination with nivolumab.

-To characterize DLT profile of BMS-986205 alone or in combination with nivolumab

Eligibility

Inclusion Criteria:

  1. Patients must have been diagnosed with cancer and had at least 1 prior standard treatment
  2. Must be able to swallow pills or capsules
  3. Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1

Exclusion Criteria:

  1. Any prior ongoing clinical study with Nivolumab with overall survival as an endpoint
  2. Requirement for daily supplemental oxygen
  3. Myocardial infarction or stroke/transient ischemic attack within the past 6 months
  4. Uncontrolled angina within the past 3 months
  5. History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus(HIV), or acquired immune deficiency syndrome(AIDS).