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Chemotherapy

BMS-813160 for Colorectal Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights

Study Summary

This trial is testing a new drug, BMS-813160, for safety and effectiveness in treating metastatic colorectal or pancreatic cancer.

Eligible Conditions
  • Colorectal Cancer
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Decrease in regulatory T cells (Treg) or tumor-associated macrophage (TAM) in tumor samples
Overall response rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary outcome measures
Accumulation index, calculated based on ratio of AUC(0-24) and Cmax at steady state to after the first dose (AI)
Apparent total body clearance (CLT/F)
Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)]
+31 more

Side effects data

From 2021 Phase 2 trial • 182 Patients • NCT02996110
38%
Constipation
34%
Fatigue
25%
Decreased appetite
25%
Nausea
25%
Cough
25%
Pruritus
22%
Rash
22%
Diarrhoea
22%
Arthralgia
22%
Back pain
16%
Pain in extremity
16%
Malignant neoplasm progression
16%
Pyrexia
16%
Myalgia
13%
Anaemia
13%
Upper respiratory tract infection
13%
Abdominal pain
13%
Flank pain
13%
Paraesthesia
13%
Oedema peripheral
13%
Dizziness
9%
Pneumonia
9%
Night sweats
9%
Stomatitis
9%
Dry eye
9%
Chills
9%
Gastroenteritis
9%
Non-cardiac chest pain
9%
Hypercalcaemia
9%
Dyspnoea
6%
Gait disturbance
6%
Dry skin
6%
Hyponatraemia
6%
Aspartate aminotransferase increased
6%
Hypoalbuminaemia
6%
Muscular weakness
6%
Epigastric discomfort
6%
Oral pain
6%
Vomiting
6%
Asthenia
6%
Influenza
6%
Fall
6%
Weight decreased
6%
Hyperkalaemia
6%
Amnesia
6%
Hypotension
6%
Rhinorrhoea
3%
Dyspnoea exertional
3%
Hypomagnesaemia
3%
Alanine aminotransferase increased
3%
Tremor
3%
Wound infection
3%
Lipase increased
3%
Pulmonary embolism
3%
Oropharyngeal pain
3%
Polymyalgia rheumatica
3%
Gastrointestinal haemorrhage
3%
Cholecystitis
3%
Wound dehiscence
3%
Blood alkaline phosphatase increased
3%
Tumour pain
3%
Spinal cord compression
3%
Pleural effusion
3%
Haematoma
3%
Sinus tachycardia
3%
Dry mouth
3%
Chest discomfort
3%
Mucosal inflammation
3%
Procedural pain
3%
Amylase increased
3%
Hyperglycaemia
3%
Hypokalaemia
3%
Hypophosphataemia
3%
Neck pain
3%
Headache
3%
Insomnia
3%
Pollakiuria
3%
Urinary retention
3%
Pleuritic pain
3%
Productive cough
3%
Erythema
3%
Palmar-plantar erythrodysaesthesia syndrome
3%
Hypertension
3%
Vertigo
3%
Adrenal insufficiency
3%
Gastrooesophageal reflux disease
3%
Muscle spasms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Track 2: Nivolumab Plus Relatlimab (BMS-986016)
Track 2: Nivolumab Plus BMS-986205
Track 1: Nivolumab Plus Relatlimab (BMS-986016)
Track 2: Nivolumab Plus BMS-813160 300 mg
Track 2: Nivolumab Plus BMS-813160 150 mg
Track 2: Nivolumab Plus Ipilimumab (BMS-734016)
Track 1: Nivolumab Plus Ipilimumab (BMS-734016)

Trial Design

13Treatment groups
Experimental Treatment
Group I: Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 MonotherapyExperimental Treatment1 Intervention
Group II: Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 MonotherapyExperimental Treatment1 Intervention
Group III: Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + NivolumabExperimental Treatment2 Interventions
Group IV: Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + NivolumabExperimental Treatment2 Interventions
Group V: Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxelExperimental Treatment2 Interventions
Group VI: Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxelExperimental Treatment4 Interventions
Group VII: Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxelExperimental Treatment3 Interventions
Group VIII: Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRIExperimental Treatment3 Interventions
Group IX: Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRIExperimental Treatment4 Interventions
Group X: Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRIExperimental Treatment4 Interventions
Group XI: Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + NivolumabExperimental Treatment2 Interventions
2L: Second-line 2/3L: Second/third-line MSS: Microsatellite stable
Group XII: Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxelExperimental Treatment3 Interventions
Group XIII: Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRIExperimental Treatment4 Interventions
FOLFIRI: FOL (folinic acid [leucovorin]) F (fluorouracil [5-fluorouracil]) IRI (irinotecan [CAMPTOSAR])
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Irinotecan
FDA approved
Paclitaxel
FDA approved
Gemcitabine
FDA approved
Fluorouracil
FDA approved
Leucovorin
FDA approved
BMS-813160
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,640 Previous Clinical Trials
4,129,132 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many Canadian institutions are conducting this analysis?

"This research project is currently accepting participants at Washington University School of Medicine in Saint Louis, Missouri, University Of Rochester in Rochester, New york and Cleveland Clinic Foundation in Cleveland Ohio. In addition to these sites, 31 more are available for enrollment."

Answered by AI

What further research has been conducted on BMS-813160?

"Research into BMS-813160 was first conducted at City of Hope Comprehensive Cancer Centre back in 1997. Since then, a total 3003 clinical trials have been completed and 2163 are currently in progress; many based out of Saint Louis, Missouri."

Answered by AI

What is the primary objective of this experiment?

"The primary intent of this two-year clinical trial is to observe a decrease in Tregs or TAMs within tumor samples. The secondary objectives involve tracking any significant changes from Part 1 and Part 2's Clinical Chemistry tests, Percent UR over 24 hours, and Blood Pressure readings."

Answered by AI

In what conditions is BMS-813160 typically prescribed?

"BMS-813160 is a commonly used medication for treating unresectable melanoma, as well as squamous cell carcinoma, cases with high risk of recurrence, and other illnesses."

Answered by AI

Are there any open enrollment opportunities for this medical experiment?

"The clinicaltrials.gov database reveals that this trial, initially posted on August 8th 2017 and last updated April 16th 2021, is no longer registering patients. However, there are 3103 other trials currently recruiting subjects for their experiments."

Answered by AI

How many participants are being accepted into this medical experiment?

"At this point of time, no more participants are being sought for this clinical trial. It was initially posted on August 8th 2017 and last updated on April 16th 2021. However, those looking to take part in a study can find 940 trials with colorectal carcinoma related research currently recruiting as well as 2163 studies utilizing BMS-813160 actively seeking patients."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors
2017. "A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03184870.
~43 spots leftby Apr 2025
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