← Back to Search

Chemotherapy

KeyLargo: Pembrolizumab + Oxaliplatin + Capecitabine in Gastric Cancer

Phase 2
Waitlist Available
Led By Hope Uronis, MD
Research Sponsored by Duke University
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 up to 44 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of three drugs to treat advanced stomach and esophagus cancer. It aims to see if the combination can help patients live longer without their cancer getting worse. The study will first check if the treatment is safe, then see how well it works. The combination of treatments has improved outcomes for patients with esophageal cancer.

Eligible Conditions
  • Stomach Cancer
  • Esophageal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 44 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 44 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Months of Progression-free Survival (PFS)
Secondary study objectives
Months of Overall Survival
Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Side effects data

From 2023 Phase 2 trial • 36 Patients • NCT03342937
42%
Anorexia
42%
Nausea
39%
Fatigue
39%
Anemia
36%
Diarrhea
36%
Peripheral sensory neuropathy
31%
Hypoalbuminemia
31%
Neutrophil count decreased
31%
Palmar-plantar erythrodysesthesia syndrome
28%
Vomiting
25%
White blood cell decreased
25%
Weight loss
19%
Hyperglycemia
19%
Dehydration
17%
Hypertension
17%
Hypokalemia
14%
Dysphagia
14%
Thromboembolic event
14%
Blood bilirubin increased
14%
Colitis
14%
Cough
14%
Insomnia
14%
Allergic rhinitis
11%
Hyponatremia
11%
Constipation
11%
Urinary tract infection
11%
Rash maculo-papular
11%
Bloating
11%
Dyspepsia
11%
Mucositis oral
11%
Alkaline phosphatase increased
11%
Anxiety
8%
Dyspnea
8%
Abdominal pain
8%
Hypothyroidism
8%
Dysgeusia
8%
Abdominal distension
8%
Hiccups
8%
Aspartate aminotransferase increased
8%
Platelet count decreased
8%
Myalgia
6%
Adrenal insufficiency
6%
Dysesthesia
6%
Otitis media
6%
Colonic obstruction
6%
Malaise
6%
Skin infection
6%
Dry skin
6%
Lung infection
6%
Pain
6%
Hypotension
6%
Skin ulceration
6%
Pleural effusion
6%
Flatulence
6%
Arthralgia
6%
Esophagitis
6%
Gastroesophageal reflux disease
6%
Alanine aminotransferase increased
6%
Weight gain
3%
Dizziness
3%
Nasal congestion
3%
Dry mouth
3%
Pericardial tamponade
3%
Sinus tachycardia
3%
Non-cardiac chest pain
3%
Hypoglycemia
3%
Toothache
3%
Syncope
3%
Hoarseness
3%
Localized edema
3%
Pneumonitis
3%
Skin hypopigmentation
3%
Metabolism and nutrition disorders - Other, Specify
3%
Skin and subcutaneous tissue disorders - Other, Specify
3%
Sinusitis
3%
Nail loss
3%
Sore throat
3%
Cystitis noninfective
3%
Pruritus
3%
Sudden death NOS
3%
Superficial thrombophlebitis
3%
Venous injury
3%
Fecal incontinence
3%
Gait disturbance
3%
Vertigo
3%
INR increased
3%
Bruising
3%
Enterocolitis infectious
3%
Hepatobiliary disorders - Other, Specify
3%
Wheezing
3%
Allergic reaction
3%
Esophageal pain
3%
Upper respiratory infection
3%
Arthritis
3%
Wound infection
3%
Urinary retention
3%
Presyncope
3%
Edema limbs
3%
Hypocalcemia
3%
Ascites
3%
Paresthesia
3%
Musculoskeletal and connective tissue disorder - Other, Specify
3%
Endocrine disorders - Other, Specify
3%
Esophageal infection
3%
Postnasal drip
3%
Voice alteration
3%
Infections and infestations - Other, Specify
3%
Lymphocyte count decreased
3%
Flank pain
3%
Eye infection
3%
Otitis externa
3%
Generalized muscle weakness
3%
Urinary incontinence
3%
Joint range of motion decreased
3%
Fever
3%
Meningitis
3%
Tumor pain
3%
Sepsis
3%
Urinary frequency
3%
Device related infection
3%
Bone pain
3%
Hyperthyroidism
3%
Gastrointestinal disorders - Other, Specify
3%
Creatinine increased
3%
Hyperkalemia
3%
Hypophosphatemia
3%
Muscle weakness lower limb
3%
Muscle weakness upper limb
3%
Erectile dysfunction
3%
Pelvic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oxaliplatin + Capecitabine + Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oxaliplatin+Capecitabine+PembrolizumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin+Capecitabine+Pembrolizumab
2018
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,767 Total Patients Enrolled
Duke UniversityLead Sponsor
2,458 Previous Clinical Trials
2,969,413 Total Patients Enrolled
Hope Uronis, MDPrincipal InvestigatorDuke University
~5 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top