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Chemotherapy

Bemarituzumab + Chemotherapy + Nivolumab for Stomach Cancer (FORTITUDE-102 Trial)

Phase 3

Waitlist Available

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

Must not have

Known positive human epidermal growth factor receptor 2 (HER2) status

Clinically significant cardiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have advanced stomach or gastroesophageal cancer that cannot be surgically removed.

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I can safely receive mFOLFOX6 chemotherapy or nivolumab.

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My hemoglobin level is at least 9 g/dL without needing a blood transfusion in the last week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is HER2 positive.

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I have a serious heart condition.

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I have moderate to severe numbness or pain in my hands or feet.

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I have an autoimmune disease treated with drugs other than replacement therapy in the last 2 years.

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I have eye conditions that could lead to a corneal ulcer.

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I have received palliative radiotherapy within the last 14 days.

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I have brain metastases or leptomeningeal disease that is untreated or causing symptoms.

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I have been treated with drugs targeting the FGF-FGFR pathway before.

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I have long-term eye problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 2 trial • 80 Patients • NCT02213289

94%

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%

Edema limbs

29%

Pain

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

Palmar-plantar erythrodysesthesia synrome

Pain in extremity

Chills

General disorders and administration site conditions - Other

Localized edema

Rash maculo-papular

Sepsis

Dyspepsia/heartburn

Nasal congestion

Neck pain

Arthralgia

Colitis

Fall

Hematuria

Aspiration

Dysphagia

Sore throat

Upper respiratory infection

Urinary track infection

Aspartate aminotransferase increased

Dry skin

Flank pain

Gastrointestinal disorders - Other

Hypoxia

Proteinuria

Abdominal distenstion

Chest pain - cardiac

Alanine aminotransferase increased

Urinary incontinence

Stroke

Hyperkalemia

Tremor

Sinusitis

Periodontal disease

Urinary tract obstruction

Urinary tract infection

Bruising

Febrile neutropenia

Leukocytosis

Pneumonitis

Gastroparesis

Pelvic infection

Esophageal obstruction

Esophagitis

Small intestinal obstruction

Blood and lymphatic system disorders - Other

Death NOS

Seizure

Blurred vision

Platelet count decreased

Catheter related infection

Dehydration

Delirium

Phlebitis infective

Renal and urinary disorders - Other

Surgical and medical procedures - Other

Syncope

Upper gastrointestinal hemorrhage

Flu like symptoms

Fracture

Gastrointestinal pain

hemorrhoidal hemorrhage

Musculoskeletal and connective tissue disorder - Other

Presyncope

Renal colic

Esophageal perforation

100%

80%

60%

40%

20%

Study treatment Arm

ITT-PTS: Personalized Treatment Strategy

Non-ITT: Standard Therapy

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Bemarituzumab

2018

Completed Phase 2

~250

Nivolumab

2015

Completed Phase 3

~4010