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Chemotherapy
Bemarituzumab + Chemotherapy + Nivolumab for Stomach Cancer (FORTITUDE-102 Trial)
Phase 3
Recruiting
Research Sponsored by Amgen
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 of 0 to 1
Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights
FORTITUDE-102 Trial Summary
This trial is testing the safety and effectiveness of two drugs, bemarituzumab and nivolumab, when used together to treat people with colorectal cancer.
Who is the study for?
This trial is for adults with advanced gastric or gastroesophageal junction adenocarcinoma that can't be removed by surgery. Participants must have an ECOG performance status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature. They should not have had prior treatments for their metastatic disease, except possibly one dose of mFOLFOX6 with or without nivolumab.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of bemarituzumab combined with chemotherapy (mFOLFOX6 or CAPOX) and nivolumab versus placebo plus the same chemotherapies and nivolumab. The goal is to see if adding bemarituzumab improves survival compared to the standard treatment without it.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion, fatigue, digestive issues like nausea and diarrhea from chemotherapy, liver enzyme changes, blood cell count variations which could increase infection risk, skin problems due to targeted therapy like rash or dry skin.
FORTITUDE-102 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have advanced stomach or gastroesophageal cancer that cannot be surgically removed.
Select...
I can safely receive mFOLFOX6 chemotherapy or nivolumab.
Select...
My hemoglobin level is at least 9 g/dL without needing a blood transfusion in the last week.
FORTITUDE-102 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Number of Participants Who Experienced DLTs
Part 1: Number of Participants Who Experienced One or More Related TEAEs
Therapeutic procedure
+5 moreSecondary outcome measures
Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
Part 1: Disease Control Rate (DCR)
Part 1: Duration of Response (DoR)
+29 moreSide effects data
From 2020 Phase 2 trial • 80 Patients • NCT0221328994%
Fatigue
85%
Neuropathy-sensory
76%
Nausea
63%
Diarrhea
60%
Anorexia
54%
Abdominal pain
47%
Constipation
46%
Vomiting
40%
Dysphagia, esophagitis, odynophagia
38%
Dysgeusia
31%
Weight loss
29%
Pain
29%
Edema limbs
29%
Back pain
29%
Anemia
28%
Paresthesia
25%
Dyspnea
25%
Fever
24%
Cough
21%
Dizzines
21%
Platelet count decreases
19%
Gastroesophagial reflux disease
19%
Mucositis oral
15%
Headache
15%
Epistaxis
15%
Hypertension
15%
Mood aleration - depression
13%
Thromboembolic event
13%
Hypokalemia
12%
Rash acneiform
12%
Pleural effusion
12%
Ascites
12%
Insomnia
12%
Neutrophil count decreased
12%
Non-cardiac chest pain
10%
Alopecia
10%
Generalized muscle weakness
10%
Bloating
10%
Blood bilirubin increased
10%
Hypotension
9%
Pain in extremity
9%
Palmar-plantar erythrodysesthesia synrome
9%
Chills
9%
General disorders and administration site conditions - Other
9%
Localized edema
9%
Rash maculo-papular
7%
Dyspepsia/heartburn
7%
Sepsis
7%
Nasal congestion
7%
Neck pain
7%
Arthralgia
7%
Colitis
7%
Fall
6%
Hematuria
6%
Dysphagia
6%
Aspiration
6%
Sore throat
6%
Upper respiratory infection
6%
Urinary track infection
6%
Aspartate aminotransferase increased
6%
Dry skin
6%
Flank pain
6%
Gastrointestinal disorders - Other
6%
Hypoxia
6%
Proteinuria
6%
Abdominal distenstion
4%
Chest pain - cardiac
4%
Alanine aminotransferase increased
4%
Urinary incontinence
3%
Stroke
3%
Hyperkalemia
3%
Tremor
3%
Sinusitis
3%
Periodontal disease
3%
Urinary tract obstruction
3%
Urinary tract infection
3%
Bruising
3%
Febrile neutropenia
3%
Leukocytosis
3%
Pneumonitis
1%
Pelvic infection
1%
Esophagitis
1%
Esophageal obstruction
1%
Gastroparesis
1%
Small intestinal obstruction
1%
Blood and lymphatic system disorders - Other
1%
Death NOS
1%
Seizure
1%
Blurred vision
1%
Platelet count decreased
1%
Catheter related infection
1%
Dehydration
1%
Delirium
1%
Phlebitis infective
1%
Renal and urinary disorders - Other
1%
Surgical and medical procedures - Other
1%
Syncope
1%
Upper gastrointestinal hemorrhage
1%
Flu like symptoms
1%
Fracture
1%
Gastrointestinal pain
1%
hemorrhoidal hemorrhage
1%
Musculoskeletal and connective tissue disorder - Other
1%
Presyncope
1%
Renal colic
1%
Esophageal perforation
100%
80%
60%
40%
20%
0%
Study treatment Arm
ITT-PTS: Personalized Treatment Strategy
Non-ITT: Standard Therapy
FORTITUDE-102 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and NivolumabExperimental Treatment3 Interventions
Participants will be administered bemarituzumab at the RP3D determined from Part 1 in combination with mFOLFOX6 and nivolumab on a 14-day cycle.
Or participants will be administered bemarituzumab in combination with CAPOX and nivolumab on a 21-day cycle.
Group II: Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and NivolumabExperimental Treatment3 Interventions
Participants will be administered bemarituzumab at different doses with mFOLFOX6 and nivolumab to determine the recommended phase 3 dose (RP3D) based on occurrence of dose-limiting toxicities (DLTs), and on an evaluation of the overall safety, tolerability, and pharmacokinetics (PK).
Group III: Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and NivolumabPlacebo Group3 Interventions
Participants will be administered placebo comparator in combination with mFOLFOX6 and nivolumab on a 14-day cycle.
Or participants will be administered placebo comparator in combination with CAPOX and nivolumab on a 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Bemarituzumab
2018
Completed Phase 2
~250
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,377,690 Total Patients Enrolled
MDStudy DirectorAmgen
915 Previous Clinical Trials
924,202 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is HER2 positive.I have a serious heart condition.I have moderate to severe numbness or pain in my hands or feet.I have an autoimmune disease treated with drugs other than replacement therapy in the last 2 years.My blood clotting time is normal or near normal, or I've been on a stable blood thinner dose for 6 weeks.I am fully active or restricted in physically strenuous activity but can do light work.My cancer can be measured or evaluated by specific criteria.I haven't had treatment for my advanced cancer, except possibly one dose of mFOLFOX6 with or without nivolumab.I have advanced stomach or gastroesophageal cancer that cannot be surgically removed.I can safely receive mFOLFOX6 chemotherapy or nivolumab.My tumor has a high level of FGFR2b, confirmed by a recent test.I have eye conditions that could lead to a corneal ulcer.I have not had major surgery or joined another study in the last 28 days.I have received palliative radiotherapy within the last 14 days.I have brain metastases or leptomeningeal disease that is untreated or causing symptoms.My hemoglobin level is at least 9 g/dL without needing a blood transfusion in the last week.I have been treated with drugs targeting the FGF-FGFR pathway before.I have long-term eye problems.I haven't had any other cancers in the last 2 years, except those treated and considered cured.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab
- Group 2: Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab
- Group 3: Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and Nivolumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the Bemarituzumab success rate in the USA?
"Bemarituzumab is a Phase 3 trial drug, which means that while there is data affirming its efficacy, there are also multiple rounds of data that support its safety. Therefore, our team at Power rates its safety as a 3."
Answered by AI
Could you explain who would be able to take part in this specific test?
"This study is looking for 702 participants who are currently suffering from adenocarcinoma and fall within the age range of 18 to 100. In addition to meeting these general requirements, patients must also have measurable or evaluable disease according to RECIST v1.1, have no contraindications to mFOLFOX6 chemotherapy or nivolumab, have an absolute neutrophil count of ≥ 1.5 x 10^9/L, a platelet count of ≥ 100 x 10^9/L, a hemoglobin level of ≥ 9 g/dL without the need for a RBC transf"
Answered by AI
Are there any openings for new patients in this clinical trial?
"That is correct, the online information does state that the research is actively looking for willing participants. The first posting was on 3/14/2022 and the most recent update was on 11/2/2022. They are hoping to have a total of 702 individuals between 30 locations."
Answered by AI
What have been found to be the most responsive treatments for Bemarituzumab?
"Bemarituzumab is a medication used to treat patients with malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
Will this research be testing seniors for the new medication?
"Eligibility for this study is restricted to individuals aged 18-100."
Answered by AI
How many other times has Bemarituzumab been involved in a medical study?
"There are 752 ongoing studies involving bemarituzumab, with 84 of them being phase 3 trials. While a few of the bemarituzumab clinical trials are based in São Paulo and Maryland, there are actually 40,668 total locations running these types of trials."
Answered by AI
Is this trial widely available to Canadian patients?
"Currently, there are 30 open clinical trials for this medication. Some notable locations include Florida Cancer Specialists - Fort Myers in Fort Myers, Olive View-University of California in Los Angeles Medical Center in Sylmar, and Saint Lukes University Health Network in Bethlehem."
Answered by AI
How many research participants will be included in this investigation?
"That is correct, the trial is ongoing. According to the information on clinicaltrials.gov, it began on 3/14/2022 and has been updated as recently as 11/2/2022. They are looking for a total of 702 patients at 30 different sites."
Answered by AI
What is the research behind this new clinical trial?
"Bemarituzumab has undergone clinical trials since 2010, with the first being sponsored by Medarex. After the initial study in 2010, which had 127 participants, Bemarituzumab received Phase 1 drug approval. There are currently 752 active trials in 54 countries across 2369 cities."
Answered by AI
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