Chemotherapy

Nivolumab for Stomach Cancer

Q: Is there any risk associated with Nivolumab treatments?

<p>Based on the current <a href="https://www.withpower.com/clinical-trials/sci">sci</a>entific evidence, our team has assigned a score of 2 for Nivolumab's safety. This is due to Phase 2 trial data indicating that there may be some safety benefits but no efficacy yet established.</p>

Q: What maladies has Nivolumab been proven to aid in addressing?

<p>Nivolumab is often prescribed to treat <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>ous growths, such as metastatic esophageal adenocarcinoma and malignant neoplasms like unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a> and <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>.</p>

Phase 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

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 25 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Study Summary

This trial is testing an investigational drug in combination with chemotherapy to treat people with gastric or gastroesophageal junction cancer that can't be removed by surgery and has spread to other parts of the body.

Eligible Conditions

Stomach Cancer
Esophagogastric Junction

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You must be able to carry out daily activities without difficulty or with little assistance.

Select...

You have been diagnosed with advanced stomach or gastroesophageal junction cancer that cannot be removed through surgery.

Select...

You have not received any medication for your stomach or esophageal cancer that has spread to other parts of the body.

Select...

You need to provide a sample of your tumor for laboratory testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 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

BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants

Secondary outcome measures

Duration of Response (DOR)

Number of Deaths

Number of Participants With Adverse Events (AEs)

+5 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Neutropenia

21%

Pyrexia

19%

Hypomagnesaemia

19%

Headache

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Weight decreased

14%

Platelet count decreased

14%

Rash

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Abdominal pain

12%

Pain in extremity

12%

Pruritus

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Chest pain

10%

Hypoalbuminaemia

10%

Dysgeusia

10%

Pneumonia

10%

Muscular weakness

10%

Productive cough

10%

Alopecia

10%

Dry skin

Hypothyroidism

Mucosal inflammation

Upper respiratory tract infection

Peripheral sensory neuropathy

Abdominal pain upper

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Chills

Bronchitis

Blood alkaline phosphatase increased

Dehydration

Hyperglycaemia

Hyperkalaemia

Lymphocyte count decreased

Anxiety

Hypertension

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Dry mouth

Malaise

Pain

Musculoskeletal chest pain

Hypotension

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Rash maculo-papular

Fall

Pulmonary embolism

Myocardial infarction

Metastases to central nervous system

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Atrial fibrillation

Cardiac failure

Adrenal insufficiency

Sepsis

Malignant pleural effusion

General physical health deterioration

Embolism

Pancytopenia

Atrial flutter

Pericardial effusion

Colitis

Gastrointestinal haemorrhage

Ileus

Small intestinal haemorrhage

Small intestinal obstruction

Performance status decreased

Femur fracture

Hypercalcaemia

Bone pain

Neoplasm progression

Pericardial effusion malignant

Confusional state

Bronchial obstruction

Pneumothorax

Respiratory tract infection

Respiratory failure

Superior vena cava syndrome

Tumour pain

Appendicitis

Skin infection

Cancer pain

Lung cancer metastatic

Ataxia

Seizure

Syncope

Circulatory collapse

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nivolumab + investigator's choice chemotherapyExperimental Treatment4 Interventions

Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX

Group II: BMS-986213 + investigator's choice chemotherapyExperimental Treatment5 Interventions

BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

XELOX

2018

Completed Phase 3

~340

FOLFOX

2009

Completed Phase 3

~4180

SOX

2014

Completed Phase 2

~80

0 / 4Eligibility criteria met

Find a site

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,576 Previous Clinical Trials

4,033,551 Total Patients Enrolled

Media Library

FOLFOX (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03662659 — Phase 2

Stomach Cancer Research Study Groups: BMS-986213 + investigator's choice chemotherapy, Nivolumab + investigator's choice chemotherapy

Stomach Cancer Clinical Trial 2023: FOLFOX Highlights & Side Effects. Trial Name: NCT03662659 — Phase 2

FOLFOX (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03662659 — Phase 2

Frequently Asked Questions

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

Could you provide an estimate of the total participants enrolled in this clinical trial?

"Currently, no participants are being sought for this particular clinical trial. The study was initially posted on October 16th 2018 and was last amended November 3rd 2022. If you are in search of other studies, 631 medical trials recruiting patients with gastric cancer and 718 trials looking to enroll Nivolumab recipients exist at present."

Answered by AI

Is this a pioneering endeavor in terms of clinical research?

"At present, there are 718 trials involving Nivolumab that are being conducted across 2354 cities and 49 nations. The initial experiment regarding this pharmaceutical was completed by Ono Pharmaceutical Co. Ltd in 2012, with 659 participants testing the drug's safety during its Phase 1 & 2 assessment period. Since then, 273 further clinical studies have been undertaken."

Answered by AI

Are there any participating sites that are located in North America for this trial?

"This clinical trial has sites scattered across North America, including Local Institution in Kelowna, British Columbia; Dallas VA Medical Center in Quebec, Nova Scotia and Uc Irvine Medical Centre located in Halifax, Texas. Additionally there are 25 other medical centres participating."

Answered by AI

Have any past studies been conducted involving Nivolumab treatment?

"Currently, there are 718 Nivolumab-based clinical trials in operation with 82 being Phase 3 evaluations. The majority of studies take place near Zürich BE; however, 40237 different sites are running related research initiatives."

Answered by AI

Is there any risk associated with Nivolumab treatments?

"Based on the current scientific evidence, our team has assigned a score of 2 for Nivolumab's safety. This is due to Phase 2 trial data indicating that there may be some safety benefits but no efficacy yet established."

Answered by AI

Are there still vacancies for prospective participants in this research project?

"This research project has closed its recruitment phase, with the initial posting on October 16th 2018 and final update on November 3rd 2022. Fortunately, there are 631 clinical trials recruiting patients suffering from stomach cancer and 718 separate studies seeking participants for treatment using Nivolumab."

Answered by AI

What maladies has Nivolumab been proven to aid in addressing?

"Nivolumab is often prescribed to treat cancerous growths, such as metastatic esophageal adenocarcinoma and malignant neoplasms like unresectable melanoma and squamous cell carcinoma."

Answered by AI

Recent research and studies

MedicineJournal

The Current Management and Biomarkers of Immunotherapy in Advanced Gastric Cancer

Chang, Xiaojing, Xiaohui Ge, Yufeng Zhang, and Xiaoying Xue. 2022. “The Current Management and Biomarkers of Immunotherapy in Advanced Gastric Cancer”. Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/md.0000000000029304.

MedicineJournal

The Current Management and Biomarkers of Immunotherapy in Advanced Gastric Cancer

clinicaltrials.govStudy

An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

2018. "An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03662659.