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DNA Methyltransferase Inhibitor

Azacitidine + Pembrolizumab for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Susan E Bates, MD
Research Sponsored by Susan E. Bates
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 24 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing whether combining immune therapy with a hypomethylating agent may help people with advanced pancreatic cancer who have progressed on first-line therapy.

Who is the study for?
This trial is for adults over 18 with advanced pancreatic cancer who've seen their disease get worse after first-line chemotherapy. They should have a life expectancy of more than 3 months, measurable disease, and be in good enough health to perform daily activities with little or no assistance. Those who've had recent chemo, radiotherapy, or participated in other drug studies can't join.
What is being tested?
The study tests combining pembrolizumab (an immune therapy given every 3 weeks) with azacitidine (a hypomethylating agent given every 4 weeks) on patients with advanced pancreatic cancer. It's an open-label trial where all participants receive the same treatment without being compared to a control group.
What are the potential side effects?
Potential side effects include reactions related to the immune system such as fatigue, skin issues, inflammation of organs like lungs or intestines; also possible are changes in blood counts leading to increased risk of infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-Free Survival (PFS)
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DOR)
Objective Response Rate (ORR)

Side effects data

From 2007 Phase 3 trial • 358 Patients • NCT00071799
67%
Thrombocytopenia
65%
Neutropenia
50%
Constipation
48%
Nausea
48%
Anaemia
43%
Injection site erythema
29%
Injection site reaction
27%
Vomiting
26%
Pyrexia
24%
Fatigue
22%
Diarrhoea
19%
Nasopharyngitis
19%
Cough
18%
Injection site pain
18%
Leukopenia
17%
Acute myeloid leukaemia
15%
Asthenia
15%
Dyspnoea
15%
Epistaxis
14%
Headache
14%
Anorexia
13%
Oedema peripheral
12%
Haematoma
12%
Abdominal pain
11%
Pneumonia
11%
Febrile neutropenia
11%
Transfusion reaction
11%
Petechiae
11%
Pruritus
10%
Oral herpes
10%
Dizziness
10%
Rash
9%
Arthralgia
9%
Back pain
9%
Bronchitis
9%
Insomnia
9%
Upper respiratory tract infection
9%
Hypertension
8%
Weight decreased
8%
Contusion
7%
Haemorrhoids
7%
Erythema
7%
Urinary tract infection
7%
Lethargy
6%
Abdominal pain upper
6%
Gingival bleeding
6%
Muscle spasms
6%
Injection site rash
6%
Influenza
6%
Oral candidiasis
6%
Rhinitis
6%
Pain in extremity
6%
Hypotension
6%
Dyspepsia
6%
Injection site haematoma
6%
Hypokalaemia
6%
Haematuria
6%
Pharyngolaryngeal pain
5%
Chest pain
5%
Mouth ulceration
5%
Musculoskeletal pain
5%
Depression
5%
Oedema
5%
Pharyngitis
5%
Anxiety
5%
Ecchymosis
5%
Injection site bruising
5%
Injection site induration
5%
Dyspnoea exertional
4%
Pain
4%
Bone pain
4%
Alopecia
4%
Skin lesion
3%
Productive cough
3%
Respiratory tract infection
3%
Conjunctival haemorrhage
3%
Tachycardia
3%
Stomatitis
3%
Dry mouth
3%
Gingivitis
3%
Chills
3%
Sinusitis
3%
Sepsis
3%
Fall
3%
Alanine aminotransferase increased
3%
Sleep disorder
2%
Gastritis
2%
General physical health deterioration
2%
Muscular weakness
2%
Purpura
2%
Catheter site haematoma
2%
Nasal congestion
2%
Neutropenic sepsis
2%
Gastrooesophageal reflux disease
2%
Hyperuricaemia
2%
Cardiac failure
2%
Bronchopneumonia
2%
Lymphopenia
2%
Rectal haemorrhage
2%
Pallor
2%
Septic shock
2%
Myelodysplastic syndrome
2%
Cerebral haemorrhage
2%
Pitting oedema
2%
Procedural pain
2%
Syncope
1%
Ocular hyperaemia
1%
Ventricular tachycardia
1%
Mouth haemorrhage
1%
Confusional state
1%
Haemorrhoidal haemorrhage
1%
Renal colic
1%
Abdominal discomfort
1%
Anal haemorrhage
1%
Subileus
1%
Lung infection
1%
Myocardial infarction
1%
Oral soft tissue disorder
1%
Catheter site haemorrhage
1%
Clostridium difficile colitis
1%
Benign prostatic hyperplasia
1%
Enterobacter infection
1%
Blood lactate dehydrogenase increased
1%
Hypophosphataemia
1%
Hypoxia
1%
Cellulitis
1%
Eye Haemorrhage
1%
Gastrointestinal haemorrhage
1%
Tooth abscess
1%
Peripheral vascular disorder
1%
Food poisoning
1%
Intestinal haemorrhage
1%
Gastrointestinal pain
1%
Delirium
1%
Conjunctivitis
1%
Pancytopenia
1%
Haematemesis
1%
Tooth disorder
1%
Meningitis
1%
Psychotic disorder
1%
Angle closure glaucoma
1%
Corynebacterium infection
1%
Herpes zoster
1%
Salmonella sepsis
1%
Subdiaphragmatic abscess
1%
Fungal skin infection
1%
Catheter site pain
1%
Joint swelling
1%
Atrial fibrillation
1%
Musculoskeletal chest pain
1%
Transient ischaemic attack
1%
Strabismus
1%
Endophthalmitis
1%
Angina pectoris
1%
Subcutaneous abscess
1%
Perianal abscess
1%
Pulmonary embolism
1%
Pleural effusion
1%
Cardiac failure acute
1%
Vertigo
1%
Oesophageal carcinoma
1%
Myopia
1%
Retinal artery occlusion
1%
Squamous cell carcinoma of skin
1%
Haemoptysis
1%
Lung infiltration
1%
Respiratory failure
1%
Pulmonary oedema
1%
Pulmonary fibrosis
1%
Hallucination
1%
Colitis ulcerative
1%
Injection site nodule
1%
Bacteraemia
1%
Bile duct stone
1%
Hepatic function abnormal
1%
Fungal sepsis
1%
Gasteroenteritis
1%
Gasteroenteritis salmonella
1%
Laryngopharyngitis
1%
Lobar pneumonia
1%
Lower respiratory tract infection
1%
Pulmonary tuberculosis
1%
Sialoadenitis
1%
Splenic abscess
1%
Staphylococcal bacteraemia
1%
Clavicle fracture
1%
Hip fracture
1%
Traumatic intracranial haemorrhage
1%
Diabetes mellitus
1%
Colon cancer
1%
Lung adenocarcinoma
1%
Neoplasm prostate
1%
Urinary tract neoplasm
1%
Coma
1%
Haemorrhage intracranial
1%
Renal failure
1%
Urethral stenosis
1%
Acute pulmonary oedema
1%
Acute respiratory failure
1%
Hypoalbuminaemia
1%
Hyponatraemia
1%
Lymphadenopathy
1%
Gingival pain
1%
Generalised oedema
1%
Catheter related infection
1%
Neck pain
1%
Dermatitis allergic
1%
Rash macular
1%
Urticaria
1%
Bone marrow failure
1%
Pericardial effusion
1%
Hypothyroidism
1%
Retinal Haemorrhage
1%
Retinal tear
1%
Abdominal wall abscess
1%
Abscess neck
1%
Ear infection
1%
Enterobacter bacteraemia
1%
Mucormycosis
1%
Neutropenic infection
1%
Parotitis
1%
Pneumonia fungal
1%
Synovial rupture
1%
Osteoporosis
1%
Myelofibrosis
1%
Loss of consciousness
1%
Urinary retention
1%
Pneumonitis
1%
Actinic keratosis
1%
Aortic aneurysm
1%
Circulatory collapse
1%
Bronchopulmonary aspergillosis
1%
Bradycardia
1%
Aphthous stomatitis
1%
Mucosal inflammation
1%
Staphylococcal infection
1%
Viral upper respiratory tract infection
1%
Scratch
1%
Thermal burn
1%
Aspartate aminotransferase increased
1%
Hypocalcaemia
1%
Bursitis
1%
Sinus headache
1%
Chromaturia
1%
Proteinuria
1%
Pleurisy
1%
Rash papular
1%
Rash pruritic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azacitidine
Low-dose Cytarabine
Best Supportive Care Only
Standard Chemotherapy

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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: PembrolizumabExperimental Treatment2 Interventions
Patients with advanced pancreatic cancer will receive pembrolizumab with the hypomethylating agent azacitidine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Azacitidine
FDA approved

Find a Location

Who is running the clinical trial?

Susan E. BatesLead Sponsor
1 Previous Clinical Trials
37 Total Patients Enrolled
Rachael A Safyan, MDLead Sponsor
Ruth A. White, MD, PhD.Lead Sponsor
Susan E Bates, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
54 Total Patients Enrolled
Rachael A. Safyan, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
30 Total Patients Enrolled
Ruth White, MD, PhDPrincipal InvestigatorColumbia University
~4 spots leftby Dec 2025
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