Bemarituzumab for Adenocarcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Adenocarcinoma+4 More
Bemarituzumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety and effectiveness of two drugs, bemarituzumab and nivolumab, when used together to treat people with colorectal cancer.

Eligible Conditions
  • Adenocarcinoma
  • Malignant Neoplasm of Stomach

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Adenocarcinoma

Study Objectives

8 Primary · 45 Secondary · Reporting Duration: Up to 4.5 years

28 days
Part 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Year 5
Part 2: Change From Baseline in EORTC QLQ-C30 Individual Scores
Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Version 3.0 (QLQ-C30) Individual Scores
Malignant Neoplasms
Part 2: Change From Baseline in Stomach Cancer Related Symptoms Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Stomach 22 (QLQ-STO22)
Part 2: Change From Baseline of VAS Scores as Measured by EQ-5D-5L
Part 2: Change From Baseline of Visual Analogue Scale (VAS) Scores as Measured by EuroQol 5-dimensional (EQ-5D-5L)
Year 5
Part 1 & 2: Maximum Observed Concentration (Cmax) for Bemarituzumab
Antibodies
Part 1 & 2: Observed Concentration at the End of a Dose Interval (Ctrough) for Bemarituzumab
Part 1: Area Under the Concentration Time Curve (AUC) for Bemarituzumab
Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab
Antibodies
Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Part 2: Cmax of Bemarituzumab
Part 2: Ctrough of Bemarituzumab
Antibodies
Part 2: Time to Deterioration in Health-Related Quality of Life (HRQoL) Scores
Part 2: Time to Deterioration in Physical Function Scores
Malignant neoplasm of stomach
Malignant neoplasm of stomach
Up to 4.5 years
Part 1 & 2: Disease Control Rate (DCR)
Part 1 & 2: Duration of Response (DoR)
Part 1 & 2: Objective Response (OR)
Part 1 & 2: Progression Free Survival (PFS)
Part 1: Disease Control Rate (DCR)
Part 1: Duration of Response (DoR)
Part 1: Number of Participants Who Experienced One or More Related TEAEs
Therapeutic procedure
Electrocardiogram
Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations
Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity
Part 1: Number of Participants With Clinically Significant Changes in Vital Signs
Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Part 1: Objective Response (OR)
Part 1: Overall Survival
Part 1: Progression Free Survival (PFS)
Part 2:
Part 2: DCR
Part 2: DoR
Part 2: Mean Score in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Version 3.0 (QLQ-C30) Individual Scores
Malignant Neoplasms
Malignant neoplasm of stomach
Part 2: Mean Score of Visual Analogue Scale (VAS) Scores as Measured by EuroQol 5-dimensional (EQ-5D-5L)
Part 2: Number of Participants Who Experienced One or More TEAEs
Therapeutic procedure
Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs
Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Part 2: Objective Response Rate (ORR)
Part 2: Overall Survival
Part 2: PFS

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Adenocarcinoma

Side Effects for

ITT-PTS: Personalized Treatment Strategy
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%Anemia
29%Back pain
29%Edema limbs
29%Pain
28%Paresthesia
25%Dyspnea
25%Fever
24%Cough
21%Dizzines
21%Platelet count decreases
19%Gastroesophagial reflux disease
19%Mucositis oral
15%Epistaxis
15%Headache
15%Mood aleration - depression
15%Hypertension
13%Hypokalemia
13%Thromboembolic event
12%Insomnia
12%Neutrophil count decreased
12%Ascites
12%Non-cardiac chest pain
12%Rash acneiform
12%Pleural effusion
10%Hypotension
10%Alopecia
10%Bloating
10%Blood bilirubin increased
10%Generalized muscle weakness
9%Chills
9%General disorders and administration site conditions - Other
9%Localized edema
9%Pain in extremity
9%Rash maculo-papular
9%Palmar-plantar erythrodysesthesia synrome
7%Sepsis
7%Arthralgia
7%Colitis
7%Fall
7%Dyspepsia/heartburn
7%Neck pain
7%Nasal congestion
6%Urinary track infection
6%Aspiration
6%Dysphagia
6%Abdominal distenstion
6%Aspartate aminotransferase increased
6%Gastrointestinal disorders - Other
6%Flank pain
6%Dry skin
6%Hematuria
6%Hypoxia
6%Proteinuria
6%Upper respiratory infection
6%Sore throat
4%Urinary incontinence
4%Alanine aminotransferase increased
4%Chest pain - cardiac
3%Stroke
3%Tremor
3%Urinary tract infection
3%Bruising
3%Febrile neutropenia
3%Hyperkalemia
3%Leukocytosis
3%Pneumonitis
3%Periodontal disease
3%Urinary tract obstruction
3%Sinusitis
1%Catheter related infection
1%Death NOS
1%Delirium
1%Platelet count decreased
1%Blood and lymphatic system disorders - Other
1%Dehydration
1%Esophageal obstruction
1%Esophageal perforation
1%Phlebitis infective
1%Esophagitis
1%Gastroparesis
1%Pelvic infection
1%Seizure
1%Renal and urinary disorders - Other
1%Syncope
1%Small intestinal obstruction
1%Surgical and medical procedures - Other
1%Upper gastrointestinal hemorrhage
1%Blurred vision
1%Fracture
1%Flu like symptoms
1%Gastrointestinal pain
1%hemorrhoidal hemorrhage
1%Musculoskeletal and connective tissue disorder - Other
1%Presyncope
1%Renal colic
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02213289) in the ITT-PTS: Personalized Treatment Strategy ARM group. Side effects include: Fatigue with 94%, Neuropathy-sensory with 85%, Nausea with 76%, Diarrhea with 63%, Anorexia with 60%.

Trial Design

3 Treatment Groups

Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and Nivolumab
1 of 3
Part 2: Bemarituzumab with mFOLFOX6 and Nivolumab
1 of 3
Part 2: Placebo with mFOLFOX6 and Nivolumab
1 of 3
Experimental Treatment
Non-Treatment Group

702 Total Participants · 3 Treatment Groups

Primary Treatment: Bemarituzumab · Has Placebo Group · Phase 3

Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and NivolumabExperimental Group · 3 Interventions: Nivolumab, mFOLFOX6, Bemarituzumab · Intervention Types: Drug, Drug, Drug
Part 2: Bemarituzumab with mFOLFOX6 and NivolumabExperimental Group · 3 Interventions: Nivolumab, mFOLFOX6, Bemarituzumab · Intervention Types: Drug, Drug, Drug
Part 2: Placebo with mFOLFOX6 and NivolumabPlaceboComparator Group · 3 Interventions: Nivolumab, mFOLFOX6, Placebo · Intervention Types: Drug, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
mFOLFOX6
2009
Completed Phase 4
~1130
Bemarituzumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4.5 years

Who is running the clinical trial?

AmgenLead Sponsor
1,291 Previous Clinical Trials
1,306,352 Total Patients Enrolled
18 Trials studying Adenocarcinoma
1,913 Patients Enrolled for Adenocarcinoma
MDStudy DirectorAmgen
834 Previous Clinical Trials
875,602 Total Patients Enrolled
11 Trials studying Adenocarcinoma
2,497 Patients Enrolled for Adenocarcinoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have no contraindications to mFOLFOX6 chemotherapy or nivolumab.
Hemoglobin ≥ 9 g/dL without RBC transfusion within 7 days prior to the first dose of study treatment.
You have a calculated creatinine clearance (CrCl) of ≥ 50 mL/minute.
You have a performance status of 0 to 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.