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Checkpoint Inhibitor

Nivolumab for Gastric Cancer (FRACTION-GC Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)
Awards & highlights

FRACTION-GC Trial Summary

This trial is testing a new cancer treatment combination to see if it is effective and safe.

Eligible Conditions
  • Gastric Cancer

FRACTION-GC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 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
Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks
Median Duration of Response (DOR)
Objective Response Rate (ORR) by Investigator
Secondary outcome measures
Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

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%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Hypertension
7%
Chills
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Cancer pain
1%
Small intestinal haemorrhage
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

FRACTION-GC Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab + RucaparibExperimental Treatment2 Interventions
Group II: Nivolumab + RelatlimabExperimental Treatment2 Interventions
Group III: Nivolumab + Ipilimumab + RucaparibExperimental Treatment3 Interventions
Group IV: Nivolumab + BMS-986205Experimental Treatment2 Interventions
Group V: Ipilimumab + RucaparibExperimental Treatment2 Interventions
Group VI: Nivolumab + IpilimumabActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Relatlimab
2018
Completed Phase 2
~1120
BMS-986205
2017
Completed Phase 3
~1200
Rucaparib
2016
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,639 Previous Clinical Trials
4,128,842 Total Patients Enrolled
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
11,481 Total Patients Enrolled

Frequently Asked Questions

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

What condition is Nivolumab most often used to treat?

"Nivolumab is often used in the treatment of melanoma that cannot be surgically removed. Additionally, this medication can also help patients with squamous cell carcinoma, and those at high risk for disease recurrence."

Answered by AI

How many individuals are taking part in this research project?

"Presently, this study is not admitting any more patients. The date the trial was originally posted was on 29th November 2016 and it was last updated 18th August 2022. There are 508 other trials for advanced gastric cancer and 823 studies involving Nivolumab that are actively recruiting participants."

Answered by AI

Could people who are 50 years old or younger participate in this clinical trial?

"The age requirements for this trial are that patients must be over 18 years old, and cannot have exceeded 110 years of age."

Answered by AI

What other tests has Nivolumab been a part of in the past?

"Nivolumab was first studied in 2009 at Texas Children's Hospital. So far, 384 clinical trials have completed with 823 more presently ongoing. A large concentration of these live studies are located in Edmonton, Alberta."

Answered by AI

Are there any prerequisites to joining this research project?

"The requirements for participation in this trial are that patients must have advanced gastric cancer and be within the age range of 18 to 110 years old. Currently, there are around 190 patients enrolled in the study."

Answered by AI

Could you please explain the risks associated with Nivolumab?

"Nivolumab's safety is based on data from Phase 2 trials, so it received a score of 2."

Answered by AI

Are new participants being enrolled in this clinical trial at this time?

"This specific trial has completed recruitment, as of 8/18/2022. It was first posted on 11/29/2016. However, there are still 508 trials for advanced gastric cancer and 823 trials for Nivolumab that are actively looking for participants."

Answered by AI

Is this trial being conducted at many locations within the state?

"In total, this study is taking place at 32 different locations. These include Cross Cancer Institute in Edmonton, Alberta; City Of Hope National Medical Center in Duarte, California; Local Institution - 0001 in Hackensack, New jersey; and 29 other centres."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer
2016. "A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02935634.
~23 spots leftby Apr 2025
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