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Chemotherapy

Oxaliplatin+Capecitabine+Pembrolizumab for Stomach 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

Study Summary

This trial will be conducted in two stages: 1) safety validation and 2) dose expansion. In the safety validation cohort, the first portion of the study will preliminarily establish the tolerability of the combination of pembrolizumab, oxaliplatin and capecitabine. Five (5) subjects will be enrolled and their safety data after 21 days of treatment will be reviewed before additional subjects are enrolled. Subjects on this portion of the study will only be enrolled at the Duke Cancer Institute. In the dose expansion cohort, the second portion of the study (ie. phase II) will enroll 30 subjects. In the dose expansion cohort

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Months of Progression-free Survival (PFS)
Secondary outcome measures
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%
Dehydration
19%
Hyperglycemia
17%
Hypertension
17%
Hypokalemia
14%
Colitis
14%
Dysphagia
14%
Allergic rhinitis
14%
Blood bilirubin increased
14%
Thromboembolic event
14%
Insomnia
14%
Cough
11%
Alkaline phosphatase increased
11%
Hyponatremia
11%
Urinary tract infection
11%
Rash maculo-papular
11%
Mucositis oral
11%
Constipation
11%
Bloating
11%
Dyspepsia
11%
Anxiety
8%
Hypothyroidism
8%
Hiccups
8%
Abdominal distension
8%
Abdominal pain
8%
Aspartate aminotransferase increased
8%
Platelet count decreased
8%
Dysgeusia
8%
Myalgia
8%
Dyspnea
6%
Flatulence
6%
Adrenal insufficiency
6%
Gastroesophageal reflux disease
6%
Otitis media
6%
Dry skin
6%
Skin ulceration
6%
Pleural effusion
6%
Esophagitis
6%
Arthralgia
6%
Pain
6%
Skin infection
6%
Hypotension
6%
Lung infection
6%
Alanine aminotransferase increased
6%
Colonic obstruction
6%
Malaise
6%
Weight gain
6%
Dysesthesia
3%
Hyperkalemia
3%
Hyperthyroidism
3%
Flank pain
3%
Cystitis noninfective
3%
Syncope
3%
Superficial thrombophlebitis
3%
Joint range of motion decreased
3%
Endocrine disorders - Other, Specify
3%
Generalized muscle weakness
3%
Muscle weakness lower limb
3%
Bruising
3%
Non-cardiac chest pain
3%
Tumor pain
3%
Sinus tachycardia
3%
Pneumonitis
3%
Device related infection
3%
Meningitis
3%
Esophageal infection
3%
Urinary incontinence
3%
Hypophosphatemia
3%
Erectile dysfunction
3%
Wheezing
3%
Enterocolitis infectious
3%
Ascites
3%
Bone pain
3%
Dry mouth
3%
Esophageal pain
3%
Toothache
3%
Fever
3%
Hypocalcemia
3%
Nasal congestion
3%
Sore throat
3%
Nail loss
3%
Otitis externa
3%
Skin hypopigmentation
3%
Pruritus
3%
Fecal incontinence
3%
Wound infection
3%
Creatinine increased
3%
Urinary frequency
3%
Sinusitis
3%
Localized edema
3%
Lymphocyte count decreased
3%
Muscle weakness upper limb
3%
Dizziness
3%
Paresthesia
3%
Postnasal drip
3%
Hoarseness
3%
Voice alteration
3%
INR increased
3%
Urinary retention
3%
Presyncope
3%
Upper respiratory infection
3%
Pelvic pain
3%
Gastrointestinal disorders - Other, Specify
3%
Venous injury
3%
Metabolism and nutrition disorders - Other, Specify
3%
Musculoskeletal and connective tissue disorder - Other, Specify
3%
Edema limbs
3%
Vertigo
3%
Pericardial tamponade
3%
Sepsis
3%
Eye infection
3%
Infections and infestations - Other, Specify
3%
Sudden death NOS
3%
Gait disturbance
3%
Hypoglycemia
3%
Arthritis
3%
Hepatobiliary disorders - Other, Specify
3%
Allergic reaction
3%
Skin and subcutaneous tissue disorders - Other, Specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oxaliplatin + Capecitabine + Pembrolizumab

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
3,890 Previous Clinical Trials
5,060,265 Total Patients Enrolled
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,450 Total Patients Enrolled
Hope Uronis, MDPrincipal InvestigatorDuke University

Frequently Asked Questions

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

At how many hospitals is this trial being conducted?

"Currently, this clinical trial has 7 sites that are recruiting patients. For example, the Scotland Health Care System in Laurinburg, Johnston Health Services Corporation in Smithfield, as well as Duke Cancer Center, Duke University in Clayton are a few of the locations where you may be able to participate."

Answered by AI

What are the main cancers that this drug treatment plan is used for?

"Oxaliplatin+Capecitabine+Pembrolizumab is commonly used to treat malignant neoplasms. This treatment option can also be effective for those struggling with unresectable melanoma, microsatellite instability high, and high risk of recurrence."

Answered by AI

How many people are being signed up for this clinical trial?

"This particular trial is not enrolling patients at this time. The listing was originally posted on January 11th, 2018 and updated for the final time on March 28th, 2022. If you are looking for other studies, 871 trials concerning oesophagus cancer and 1550 trials regarding Oxaliplatin+Capecitabine+Pembrolizumab are currently admitting patients."

Answered by AI

Are there any precedents for this combination of drugs in previous clinical trials?

"As of now, there are 1550 clinical trials underway that involve Oxaliplatin+Capecitabine+Pembrolizumab. Of these studies, 311 are in Phase 3. Most research efforts for this combination therapy are based in Guangzhou, Guangdong; however, there are55528 total locations with active trials."

Answered by AI

Are there any more places open for people who want to participate in this research?

"This particular clinical trial, which was created on 1/11/2018 and edited on 3/28/2022, is not currently looking for patients. However, there are 2421 other trials that are actively recruiting individuals."

Answered by AI

What are the most severe side effects that have been associated with this combination of drugs?

"While Phase 2 trials offer less evidence than later stages in the development process, our team at Power believes that the combination of Oxaliplatin+Capecitabine+Pembrolizumab is safe enough to merit a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
KeyLargo: Pembrolizumab + Oxaliplatin + Capecitabine in Gastric Cancer
2018. "KeyLargo: Pembrolizumab + Oxaliplatin + Capecitabine in Gastric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03342937.
~5 spots leftby Apr 2025
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