A Phase 2 interventional study of Pembrolizumab and Azacitidine in Pancreas Cancer, sponsored by Susan E. Bates. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Susan E. Bates · Phase 2, Interventional, and Treatment
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Among 20 studies testing pembrolizumab in Pancreatic Neoplasms — 5 open to participants now, 9 under way, 1 of them phase 3. pembrolizumab · Pancreatic Neoplasms.
Among the 20 studies testing pembrolizumab in Pancreatic Neoplasms, this one is the 11th largest by enrollment, is one of 2 that started in 2017, is one of 12 in phase 2, and was the 6th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.
Browse Pancreatic Neoplasms studies →5 of the 20 studies testing pembrolizumab in Pancreatic Neoplasms are open now, in 2 countries. Recruiting first, the newest first:
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 19+
Baylor College of Medicine · Sites in United States
Ages 18+
Second Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 18–70
Second Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–72
By country, each count listing its studies:
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, pembrolizumab is the treatment under test here. Read study by study →
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 16 · Phase 3 1 · Phase 4 1
First in 2010; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 38 across the 20 interventional studies. Of the 9 that completed or were terminated, 5 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 20 have an industry lead sponsor. The 10 most frequent:
Susan E. Bates is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Susan E. Bates has 2 studies filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies testing pembrolizumab in Pancreatic Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05093231Cambridge University Hospitals NHS Foundation TrustPembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer | 2026-11-30 |
| NCT05132504Baylor College of MedicineNeoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer | 2027-05-21 |
| NCT05462496Icahn School of Medicine at Mount SinaiModulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer | 2027-08 |
Add all 3 to your calendar (.ics) → With an account.
Among the 20 studies testing pembrolizumab in Pancreatic Neoplasms, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine the effectiveness of combining immune therapy, pembrolizumab, with a hypomethylating agent, azacitidine, for pancreatic cancer. People who have advanced pancreatic cancer with disease progression on first-line therapy are usually treated with a second chemotherapy regimen. However, there is no single accepted chemotherapy regimen and national guidelines recommend chemotherapy or clinical trial participation. In this study, all study subjects will receive a combination of immune therapy (every 3 weeks) and a hypomethylating agent (every 4 weeks). To date, studies have shown that combining a hypomethylating agent with chemotherapy or immune therapy may benefit patients across different solid tumor types including pancreatic cancer. Preclinical data in a mouse model of pancreatic cancer demonstrates improvement in survival with the combination of a hypomethylating agent and immune therapy. However, the use of single agent hypomethylating agent or immune therapy has not been shown to be effective in patients with pancreatic cancer. The one exception, to date, is the use of immune therapy in those individuals with a particular genetic feature known as mismatch repair deficiency and microsatellite instability. The combination of immune therapy and a hypomethylating agent has not been studied in human subjects and is not approved by the FDA for use in pancreatic cancer.
This is a non-randomized, single-center, open-label trial of pembrolizumab and azacitidine in subjects with locally advanced or metastatic pancreatic adenocarcinoma. Approximately 31 individuals will be asked to participate in this study.
Pancreatic ductal adenocarcinoma (PDA) has the worst prognosis of any major malignancy in the United States and, unlike other common cancers, annual deaths from PDA are rising. Despite recent advances, cytotoxic chemotherapy for PDA has been disappointing. Even among the small subset of patients who are suitable for surgical resection at the time of diagnosis, complete resection is followed by recurrence in majority of patients without further systemic therapy. Thus all PDA patients require systemic chemotherapy and more effective regimens are urgently needed.
Combination chemotherapy is effective in controlling disease and prolonging survival in patients with advanced pancreatic cancer. Despite recent successful phase 3 studies in the first-line setting, there is no defined second-line treatment for patients who experience disease progression following first-line therapy. Consensus guidelines (such as the National Comprehensive Cancer Network (NCCN) guidelines) recommend clinical trial participation in this setting.
The investigators' pre-clinical data suggests that decitabine treatment in the KPC model of pancreatic cancer leads to a significant up-regulation of interferon-related genes and a polarization of the infiltrating immune cells. Based on these results, the investigators have evaluated the effect of single agent decitabine or anti-PD1H (a homologue of PD1 with very similar function and expression pattern) compared to combination therapy (treatment with decitabine followed by PD1H blockade). The investigators' preliminary results showed minimal effect of either agent alone on tumor growth but marked decrease in tumor progression in the combination arm. These results form the foundation of this phase II study.
This study will treat patients with the combination of azacitidine and pembrolizumab. A direct comparison between azacitidine and decitabine in terms of efficacy within a controlled clinical trial has not been performed thus far. In randomized myelodysplastic syndrome (MDS) trials, the remission rates were similar for azacitidine and decitabine but the overall survival in the experimental arm was significantly shorter in the decitabine trial compared to the azacitidine trial. A primary reason to utilize azacitidine in this setting is our desire to amply reduced dose therapy with the goal of maintaining subjects on therapy Low-dose azacitidine is being tested in phase I/II clinical trials for advanced solid tumors-mainly colorectal cancer, small-cell lung carcinomas, ovarian cancer, and breast cancer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with advanced pancreatic cancer will receive pembrolizumab with the hypomethylating agent azacitidine.
Drug: Pembrolizumab · Drug: Azacitidine
Pembrolizumab 200 mg IV every 3 weeks until progression
Also known as: Keytruda
50 mg/m2 subcutaneous daily for 5 days every 28 days
Also known as: Vidaza
Progression-Free Survival (PFS)
PFS is defined as the time from the first day of trial treatment to the first documented disease progression per RECIST 1.1 (At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)) or death due to any cause, whichever occurs first.
Time frame: 24 months
Objective Response Rate (ORR)
ORR is defined as the percentage of the participants in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1.
Time frame: Throughout study duration, up to approx 80 months
Duration of Response (DOR)
For subjects who demonstrate CR or PR, based on assessments per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: Throughout study duration, up to approx 80 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments per RECIST 1.1.
Time frame: Throughout study duration, up to approx 80 months
| Milestone | Pembrolizumab |
|---|---|
| Started | 36 |
| Completed | 2 |
| Not completed | 34 |
| Withdrew: Death | 2 |
| Withdrew: Physician decision | 1 |
| Withdrew: Disease progression | 28 |
| Withdrew: Adverse event | 1 |
| Withdrew: Off study prior to treatment | 2 |
PFS is defined as the time from the first day of trial treatment to the first documented disease progression per RECIST 1.1 (At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)) or death due to any cause, whichever occurs first.
| months | Pembrolizumab |
|---|---|
| Progression-Free Survival (PFS) | 1.49 (1.38 to 1.74) |
ORR is defined as the percentage of the participants in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1.
| percentage of participants | Pembrolizumab |
|---|---|
| Objective Response Rate (ORR) | 9.7 |
For subjects who demonstrate CR or PR, based on assessments per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
| days | Pembrolizumab |
|---|---|
| Patient 1 | 2274 |
| Patient 2 | 881 |
| Patient 3 | 28 |
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments per RECIST 1.1.
| percentage of participants | Pembrolizumab |
|---|---|
| Disease Control Rate (DCR) | 35.5 |
Collected over Throughout study duration, up to approx 80 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab | 26/36 (72.2%) | 9/36 (25%) | 36/36 (100%) |
| Event | Pembrolizumab |
|---|---|
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/36 |
| Gastric hemorrhageGeneral disorders | 2/36 |
| Abdominal painGastrointestinal disorders | 2/36 |
| Endocrine disordersEndocrine disorders | 1/36 |
| Nervous system disordersNervous system disorders | 1/36 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/36 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/36 |
| StrokeNervous system disorders | 1/36 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/36 |
| SepsisInfections and infestations | 1/36 |
| Event | Pembrolizumab |
|---|---|
| DiarrheaGastrointestinal disorders | 13/36 |
| ConstipationGastrointestinal disorders | 12/36 |
| Abdominal PainGastrointestinal disorders | 9/36 |
| AnorexiaMetabolism and nutrition disorders | 9/36 |
| FatigueGeneral disorders | 8/36 |
| Alkaline phosphatase increasedInvestigations | 7/36 |
| Blood bilirubin increasedInvestigations | 7/36 |
| BloatingGastrointestinal disorders | 7/36 |
| Injection site reactionGeneral disorders | 7/36 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 6/36 |
| Age, Continuous(years) | Pembrolizumab |
|---|---|
| Mean | 64.3 ± 9.79 |
| Sex: Female, Male(Participants) | Pembrolizumab |
|---|---|
| Female | 10 |
| Male | 26 |
| Race (NIH/OMB)(Participants) | Pembrolizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 28 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Pembrolizumab |
|---|---|
| United States | 36 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2017 to primary completion in Oct 2021, 48 months.
Results were first posted in Jul 2023, 1 year 9 months after primary completion.
Of 324 non-industry phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's 48 months is below that.
Counting every sponsor, half of 393 studies reached it within 57 months; a quarter within 35 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pembrolizumab · Azacitidine
Susan E. Bates