Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Nivolumab

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cyclesore cycles

* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles

* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles

BMS-813160 will be supplied by Bristol Myers Squibb

BMS-813160

Nivolumab will be supplied by Bristol Myers Squibb

Gemcitabine will be given as per routine care from commercial supply.

Nab-paclitaxel will be given as per routine care from commercial supply.

Nab-paclitaxel

Pre-treatment, end of cycle 2, end of treatment for patients who progress or otherwise do not go to surgery, and surgery for patients who do go to surgery

Biopsy

-Cycle 1 Day 1 before treatment begins, after 2 cycles of treatment +/- 3 days of mandatory tumor biopsy, end of treatment for patients who progress or otherwise do not go to surgery, and no more than 24 hours prior to time of surgery (if applicable)

Peripheral blood

Kian-Huat Lim, M.D., Ph.D.

The purpose of this research study is to learn more about a new combination of drugs being given to treat pancreatic cancer. The drugs being tested are BMS-813160, nivolumab, gemcitabine, and nab-paclitaxel. The investigators will be looking at both the side effects and the way the disease responds to treatment.

Part A: 16 patients will be randomized to 1:1 to control or experimental arm through block randomization without stratification factors. After 8 evaluable patients have been enrolled and treated on the control arm, subsequent patients are enrolled only into the experimental arm.

BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

A Phase I/II Study to Evaluate the Tolerability and Efficacy of BMS-813160 (CCR2/5 Inhibitor) With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.

* Objective response rate (ORR) is defined as number of participants with complete response or partial response.
* Complete Response (CR): Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Normalization of tumor marker level.
* Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

* PFS is defined as the days from the date of treatment and death or progression, which occurs first. Patients alive without progression or lost to follow-up are censored at the last follow-up.
* Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

OS is defined as days from date of treatment to date of death within 3 years after surgical resection. Patients alive or lost to follow-up are censored at the last treatment on study or 3 years after surgical resection, regardless of subsequent treatment received.

Bristol-Myers Squibb

The Foundation for Barnes-Jewish Hospital

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Washington University School of Medicine

* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles

Part A - Experimental Dose Level 0

Part A - Control (Chemotherapy Only)

Part B - Dose Expansion

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Grade 1-2 anemia

Grade 3 anemia

Grade 1-2 leukocytosis

Grade 1-2 abdominal pain

Grade 1-2 constipation

Grade 1-2 diarrhea

Grade 3 diarrhea

Grade 1-2 hemorrhoids

Grade 1-2 mucositis oral

Grade 1-2 nausea

Grade 4 upper gastrointestinal hemorrhage

Grade 1-2 vomiting

Grade 1-2 chills

Grade 1-2 edema limbs

Grade 1-2 fatigue

Grade 3 fatigue

Grade 1-2 fever

Grade 1-2 foot pain

Grade 1-2 sweating

Grade 1-2 activated partial thromboplastin time prolonged

Grade 1-2 alanine aminotransferase increased

Grade 3 alanine aminotransferase increased

Grade 1-2 alkaline phosphatase increased

Grade 3 alkaline phosphatase increased

Grade 1-2 aspartate aminotransferase increased

Grade 3 aspartate aminotransferase increased

Grade 1-2 creatinine increased

Grade 1-2 lymphocyte count decreased

Grade 3 lymphocyte count decreased

Grade 1-2 neutrophil count decreased

Grade 3 neutrophil count decreased

Grade 4 neutrophil count decreased

Grade 1-2 platelet count decreased

Grade 1-2 white blood cell decreased

Grade 3 white blood cell decreased

Grade 1-2 anorexia

Grade 1-2 dehydration

Grade 1-2 hyperglycemia

Grade 3 hyperglycemia

Grade 1-2 hypoalbuminemia

Grade 1-2 hypocalcemia

Grade 1-2 hypoglycemia

Grade 1-2 hypokalemia

Grade 3 hypokalemia

Grade 1-2 hyponatremia

Grade 3 hyponatremia

Grade 1-2 arthralgia

Grade 1-2 back pain

Grade 1-2 myalgia

Grade 1-2 pain in extremity

Grade 1-2 vertigo

Grade 1-2 dizziness

Grade 1-2 dysgeusia

Grade 1-2 headache

Grade 1-2 paresthesia

Grade 1-2 peripheral sensory neuropathy

Grade 1-2 tremor

Grade 1-2 depression

Grade 1-2 insomnia

Grade 1-2 cough

Grade 1-2 dyspnea

Grade 3 dyspnea

Grade 1-2 epistaxis

Grade 1-2 hoarseness

Grade 1-2 nasal congestion

Grade 1-2 pneumonitis

Grade 1-2 alopecia

Grade 1-2 dermatitis

Grade 1-2 discoloration

Grade 1-2 nail ridging

Grade 1-2 pruritis

Grade 1-2 rash maculopapular

Grade 1-2 skin hyperpigmentation

Grade 1-2 acute kidney injury

Grade 1-2 dysuria

Grade 1-2 hematuria

Grade 1-2 proteinuria

Grade 3 cholangitis

Grade 1-2 cholecystitis

Grade 3 gallbladder obstruction

Grade 1-2 hypertension

Grade 3 hypertension

Grade 1-2 hypotension

Grade 1-2 thromboembolic event

Grade 1-2 chest swelling

Grade 1-2 sinus bradycardia

Grade 1-2 vaginal bleeding

Grade 1-2 bruising

Grade 1-2 infusion related reaction

Grade 1-2 wound dehiscence

Grade 3 sepsis

Grade 1-2 gallbladder infection

Grade 1-2 upper respiratory infection

-Only participants enrolled in Part A- Experimental Dose Level 0 are evaluable for this outcome measure.

(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events

Part A - Control participants are not evaluable for this outcome measure. 1 participant enrolled in Part A - Experimental Dose Level 0 is not evaluable for this outcome measure as the participant withdrew prior to the imaging scan. 2 participants enrolled in Part B - Dose expansion were not evaluable for this outcome measure as 1 participant withdrew prior to the imaging scan and 1 participant died prior to the imaging scan.

(Part B and Part A Experimental Dose Level 0 Only): Objective Response Rate

Only participants enrolled to Part A - Experimental Dose Level 0 and Part B - Dose expansion were evaluable for this outcome measure.

(Part B and Part A Experimental Dose Level 0 Only): Percentage of Patients Whose Disease Becomes Resectable After Treatment

(Part B and Part A Experimental Dose Level 0 Only): Progression-free Survival (PFS)

(Part B and Part A Experimental Dose Level 0 Only): Overall Survival (OS)

Overall Study

Spots Global Cancer Trial Database for BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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