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Immunotherapy

M7824 for Cholangiocarcinoma

Phase 2
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
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 at day 15, day 29, day 43, day 85, day 127, day 169, day 253, day 337, day 421 and day 505
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a treatment called M7824, which is used alone to help the immune system fight cancer. It is aimed at patients with advanced biliary tract cancer who did not respond to or could not handle standard chemotherapy.

Eligible Conditions
  • Cholangiocarcinoma
  • Bile Duct Cancer
  • Biliary Tract Cancer
  • Gallbladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 15, day 29, day 43, day 85, day 127, day 169, day 253, day 337, day 421 and day 505
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 15, day 29, day 43, day 85, day 127, day 169, day 253, day 337, day 421 and day 505 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Secondary study objectives
Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Durable Response Rate (DRR) Acoording to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator
Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status
+15 more

Side effects data

From 2024 Phase 3 trial • 304 Patients • NCT03631706
34%
Pruritus
32%
Rash
30%
Anaemia
20%
Fatigue
19%
Dyspnoea
19%
Pyrexia
18%
Haemoptysis
17%
Asthenia
17%
Decreased appetite
16%
Diarrhoea
15%
Aspartate aminotransferase increased
15%
Cough
13%
Gamma-glutamyltransferase increased
13%
Arthralgia
13%
Nausea
13%
Alanine aminotransferase increased
12%
Blood alkaline phosphatase increased
11%
Insomnia
11%
Hypothyroidism
11%
Rash maculo-papular
11%
Constipation
11%
Hypoalbuminaemia
10%
Epistaxis
9%
Oedema peripheral
9%
Vomiting
9%
Headache
9%
Hyperglycaemia
8%
Keratoacanthoma
8%
Dizziness
8%
Lipase increased
7%
Hyponatraemia
7%
Myalgia
7%
Urinary tract infection
7%
Hypotension
7%
Weight decreased
6%
Pneumonia
6%
Dry Skin
6%
Blood bilirubin increased
6%
Blood creatinine increased
6%
Upper respiratory tract infection
6%
Amylase increased
6%
Hyperuricaemia
5%
Hyperkeratosis
5%
Rash pruritic
5%
Productive cough
5%
Back pain
5%
Chest pain
4%
Hyperthyroidism
4%
Disease progression
3%
Hypokalaemia
3%
Hypomagnesaemia
3%
Pneumothorax
3%
Squamous cell carcinoma of skin
3%
Dyspepsia
2%
Hypertension
2%
Pulmonary haemorrhage
2%
Keratoacanthom
2%
Abdominal pain upper
1%
Skin toxicity
1%
Blood thyroid stimulating hormone increased
1%
Fluid overload
1%
Troponin increased
1%
Skin infection
1%
Myopathy
1%
Bladder cancer
1%
Death
1%
Tumour haemorrhage
1%
Stevens-Johnson syndrome
1%
Sudden death
1%
Cancer pain
1%
Acute myocardial infarction
1%
Infusion related reaction
1%
Platelet count decreased
1%
Aplastic anaemia
1%
Autoimmune haemolytic anaemia
1%
Fall
1%
Iron deficiency anaemia
1%
Oesophageal ulcer
1%
Arrhythmia
1%
Influenza
1%
Hypercalcaemia
1%
Coronary artery disease
1%
Malaise
1%
Infection
1%
Pneumonia staphylococcal
1%
Fractured sacrum
1%
Chronic obstructive pulmonary disease
1%
Hypoxia
1%
Pleural effusion
1%
Pneumonitis
1%
Drug eruption
1%
Eczema
1%
Toxic skin eruption
1%
Embolism
1%
Superior vena cava syndrome
1%
Agranulocytosis
1%
Angina pectoris
1%
Fracture pain
1%
Spondylitis
1%
Cerebral infarction
1%
Renal failure
1%
Lichen planus
1%
Immune-mediated enterocolitis
1%
Pericardial effusion
1%
Immune thrombocytopenia
1%
Adrenal insufficiency
1%
Oral candidiasis
1%
Bile duct stone
1%
Cholecystitis
1%
Immune-mediated nephritis
1%
Aortic aneurysm
1%
Transaminases increased
1%
Bacterial sepsis
1%
Bronchitis
1%
Strangulated incisional hernia
1%
Thoracic vertebral fracture
1%
Encephalitis
1%
Pulmonary sepsis
1%
Diabetes mellitus
1%
Sciatica
1%
Asthma
1%
Dermatitis bullous
1%
Hypersensitivity
1%
Cholestasis
1%
Hyperthermia
1%
Hepatotoxicity
1%
Lower respiratory tract infection
1%
Colitis
1%
Viral upper respiratory tract infection
1%
Urinary tract infection bacterial
1%
Pancreatitis
1%
General physical health deterioration
1%
Duodenitis
1%
Upper gastrointestinal haemorrhage
1%
Gastric ulcer haemorrhage
1%
Gastrointestinal haemorrhage
1%
Hepatitis
1%
Hip fracture
1%
Bladder transitional cell carcinoma
1%
Erythema
1%
Pemphigoid
1%
Respiratory failure
1%
Interstitial lung disease
1%
Erythema multiforme
1%
Orthostatic hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
M7824
Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: M7824Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
M7824
2018
Completed Phase 3
~710

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
83 Previous Clinical Trials
22,332 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
309 Patients Enrolled for Cholangiocarcinoma
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
444 Previous Clinical Trials
114,488 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
309 Patients Enrolled for Cholangiocarcinoma
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
298 Previous Clinical Trials
60,766 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
309 Patients Enrolled for Cholangiocarcinoma
~24 spots leftby Dec 2025
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