A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pancreatic Cancer; Colorectal Cancer

Treatments: Biological: Nivolumab; Drug: Nab-paclitaxel; Drug: 5-fluorouracil (5-FU); Drug: Irinotecan; Drug: BMS-813160; Drug: Gemcitabine; Drug: Leucovorin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03184870

2017-001725-40 (EudraCT Number)

CV202-103

Details and patient eligibility

About

The purpose of this study is to evaluate the safety profile, tolerability, drug levels, drug effects, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic colorectal and pancreatic cancers.

Enrollment: 332 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:

• Must have metastatic colorectal or pancreatic cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
• Ability to swallow pills or capsules
• Required to undergo mandatory pre and on-treatment biopsies
• Adequate marrow function
• Adequate other organ functions
• Ability to comply with study visits, treatment, procedures, pharmacokinetic (PK) and pharmacodynamic (PD) sample collection, and required study follow-up

Exclusion Criteria:

• Histology other than adenocarcinoma (neuroendocrine or acinar cell)
• Suspected, known, or central nervous system (CNS) metastases (Imaging required only if participants are symptomatic)
• Active, known or suspected autoimmune disease
• Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
• Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
• Prior treatment with cysteine-cysteine chemokine receptor 2 (CCR2) and/or cysteine-cysteine chemokine receptor 5 (CCR5) inhibitors, programmed death-1 receptor (PD-1), programmed death-ligand 1 [PD(L)-1] or cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibodies
• History of allergy to study treatments or any of its components of the study arm that participant is enrolling

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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332 participants in 13 patient groups

Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI

Experimental group

Description:

FOLFIRI: FOL (folinic acid \[leucovorin\]) F (fluorouracil \[5-fluorouracil\]) IRI (irinotecan \[CAMPTOSAR\])

Treatment:

Drug: Leucovorin

Drug: Irinotecan

Drug: BMS-813160

Drug: 5-fluorouracil (5-FU)

Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel

Experimental group

Treatment:

Drug: Gemcitabine

Drug: BMS-813160

Drug: Nab-paclitaxel

Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab

Experimental group

Description:

2L: Second-line 2/3L: Second/third-line MSS: Microsatellite stable

Treatment:

Drug: BMS-813160

Biological: Nivolumab

Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI

Experimental group

Treatment:

Drug: Leucovorin

Drug: Irinotecan

Drug: BMS-813160

Drug: 5-fluorouracil (5-FU)

Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI

Experimental group

Treatment:

Drug: Leucovorin

Drug: Irinotecan

Drug: BMS-813160

Drug: 5-fluorouracil (5-FU)

Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI

Experimental group

Treatment:

Drug: Leucovorin

Drug: Irinotecan

Drug: 5-fluorouracil (5-FU)

Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel

Experimental group

Treatment:

Drug: Gemcitabine

Drug: BMS-813160

Drug: Nab-paclitaxel

Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel

Experimental group

Treatment:

Drug: Gemcitabine

Drug: BMS-813160

Drug: Nab-paclitaxel

Biological: Nivolumab

Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab

Experimental group

Treatment:

Drug: BMS-813160

Biological: Nivolumab

Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab

Experimental group

Treatment:

Drug: BMS-813160

Biological: Nivolumab

Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy

Experimental group

Treatment:

Drug: BMS-813160

Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy

Experimental group

Treatment:

Drug: BMS-813160