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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Cancer

Treatments: Biological: Tetanus vaccine; Drug: BMS-986178; Biological: DPV-001 vaccine; Drug: Nivolumab; Drug: Ipilimumab; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02737475

CA012-004

2015-004816-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 9 patient groups

Part 1: Dose Escalation

Experimental group

Description:

* BMS-986178 at specified doses at specified intervals * Enrollment is closed for this arm

Treatment:

Drug: BMS-986178

Part 2: Dose Escalation and Expansion

Experimental group

Description:

* BMS-986178 in combination with Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm

Treatment:

Drug: Nivolumab

Drug: BMS-986178

Part 3: Dose Escalation and Expansion

Experimental group

Description:

* BMS-986178 in combination with Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm

Treatment:

Drug: Ipilimumab

Drug: BMS-986178

Part 4: Dose Schedule and Exploration

Experimental group

Description:

* BMS-986178/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm

Treatment:

Drug: Nivolumab

Drug: BMS-986178

Part 5: Dose Schedule and Exploration

Experimental group

Description:

* BMS-986178/Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm

Treatment:

Drug: Ipilimumab

Drug: BMS-986178

Part 6: Dose Safety and Expansion

Experimental group

Description:

* BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm

Treatment:

Drug: Ipilimumab

Drug: Nivolumab

Drug: BMS-986178

Part 7: Dose Safety and Expansion

Experimental group

Description:

* BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm

Treatment:

Drug: Ipilimumab

Drug: Nivolumab

Drug: BMS-986178

Part 8: Dose Exploration

Experimental group

Description:

* BMS-986178/Nivolumab with tetanus vaccine at specified doses and interval * Enrollment is closed for this arm

Treatment:

Biological: Tetanus vaccine

Drug: Nivolumab

Drug: BMS-986178

Part 9: Dose Exploration

Experimental group

Description:

* BMS-986178/Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 1) at specified doses at specified intervals OR Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 2) at specified doses at specified intervals * Enrollment is open for this arm \[Tumor type triple negative breast cancer (TNBC)\]

Treatment:

Drug: Nivolumab

Biological: DPV-001 vaccine

Drug: BMS-986178

Drug: Cyclophosphamide