Phase 2
Completed N=166
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread
Source: ClinicalTrials.gov NCT02737475 ↗Enrolled (actual)
166
Serious AEs
62.1%
Results posted
Jan 2022
Primary outcomePrimary: The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants
Summary
The purpose of the study is to determine the safety and tumor-shrinking ability of experimental medication BMS-986178, when given by itself or in combination with Nivolumab and/or Ipilimumab, in participants with solid cancers that are advanced or have spread.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY The Number of Participants Experiencing Adverse Events (AEs) |
4; 4; 4; 3; 4; 7 | — |
| PRIMARY The Number of Participants Experiencing Serious Adverse Events (SAEs) |
3; 4; 2; 3; 3; 3 | — |
| PRIMARY The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY The Number of Participant Deaths |
4; 4; 3; 4; 4; 3 | — |
| PRIMARY The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology) |
2; 0; 4; 1; 2; 1 | — |
| PRIMARY The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION) |
2; 2; 2; 1; 3; 5 | — |
| PRIMARY The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING ) |
4; 3; 2; 2; 1; 2 | — |
| SECONDARY Objective Response Rate (ORR) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Duration of Response (DOR) |
NA; 17.14; NA; NA; NA; 64.14 | — |
| SECONDARY Progression Free Survival (PFS) Rate at 24 Weeks |
0.0; 0.0; 0.0; 25.0; 25.0; 17.9 | — |
| SECONDARY Cmax: Maximum Observed Serum Concentration |
4964; 11245; 19254; 36143; 68774; 9424 | — |
| SECONDARY Tmax: Time of Maximum Observed Serum Concentration |
0.675; 0.575; 4.58; 2.30; 0.558; 0.467 | — |
| SECONDARY AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t |
577541; 1678196; 1825502; 5024906; 9981469; 609426 | — |
| SECONDARY AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval |
577541; 1599886; 3142196; 5854143; 9981469; 663257 | — |
| SECONDARY Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected |
657; 2577; 5354; 10852; 16514; 756 | — |
| SECONDARY CLT: Total Body Clearance |
0.018; 0.013; 0.011; 0.022; 0.011; 0.024 | — |
| SECONDARY Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau) |
4379; 25131; 55386; 3715; 10739; 4964 | — |
| SECONDARY AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax) |
0.793; 1.05; 1.67; 1.40; 1.52; 1.32 | — |
| SECONDARY AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC) |
1.28; 1.56; 1.77; 0.000; 1.37; 2.13 | — |
| SECONDARY AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau) |
1.90; 1.22; 1.89; 0.000; 2.47; 2.72 | — |
| SECONDARY T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax) |
229; 345; 429; 0.000; 261; 146 | — |
| SECONDARY Ctrough: Trough Observed Plasma Concentration |
1535; 1912; 1354; 1108; 1391; 1107 | — |
| SECONDARY Frequency of Positive Anti-Drug Antibodies (ADA) to BMS-986178 |
0; 0; 1; 0; 0; 3 | — |
| SECONDARY Frequency of Positive Anti-Drug Antibodies (ADA) to Nivolumab |
0; 1; 1; 0; 0; 3 | — |
| SECONDARY Frequency of Positive Anti-Drug Antibodies (ADA) to Ipilimumab. |
0; 0; 1; 0; 1; 0 | — |
| SECONDARY The Number of Participants Showing a Change in Soluble OX40 and Peripheral OX40 Receptor Occupancy Pharmacodynamic Biomarkers in Part 8 |
1; 2; 1; 0; 1; 1 | — |
| SECONDARY Tumor Pharmacodynamics of BMS-986178 in Combination With Nivolumab or Nivolumab Monotherapy in Part 8 |
— | — |
| SECONDARY The Number of Participants With Sustained T Cell Expansion With DPV-001 in Combination With Nivolumab or Nivolumab Monotherapy in Part 9 |
— | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
For Part 9 (only arm open for enrollment):
- Stage IV metastatic or unresectable triple negative breast cancer (TNBC) with zero or one prior systemic therapies in the advanced metastatic setting
- Participants with < 12 months from receipt of last curative-intent chemotherapy are allowed; curative chemotherapy will be considered first-line therapy
- Prior receipt of chemotherapy in the (neo)adjuvant setting is acceptable, as long as completed greater than 6 months from start of treatment
- Tumor biopsy samples (mandatory pre- and on-treatment biopsies) are required for all participants enrolled
- Must have histologic or cytologic confirmation of a malignancy that is advanced (metastatic, recurrent, refractory, and/or unresectable) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Men and women must agree to follow specific methods of contraception, if applicable
Exclusion Criteria
- Must be immunotherapy treatment naïve, including no prior therapy with T cell immune checkpoint blocker (anti-PDL1, anti-PD1). Prior receipt of intralymphatic cytokine therapy (IRX-2) is acceptable (Part 9 only)
- Other active malignancy requiring concurrent intervention
- Prior therapy with any agent specifically targeting T-cell co-stimulation pathways such as anti-OX40 antibody, anti-CD137, anti- glucocorticoid-induced TNFR-related gene (anti-GITR) antibody, and anti-CD27
- Known or underlying medical or psychiatric condition and/or social reason that, in the opinion of the investigator or Sponsor, could make the administration of study drug hazardous to the participant or could adversely affect the ability of the participant to comply with or tolerate the study
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02737475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.