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Pancreatic AdenocarcinomaPhase 1/2NCT03245541

Radiation Therapy in Combination With Durvalumab for People With Pancreatic Cancer

A Phase 1/2 study testing Durvalumab and Stereotactic Ablative Body Radiotherapy (SABR) in people with Pancreatic Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to find out if combining durvalumab with standard stereotactic ablative radiotherapy (SABR) is an effective treatment for people with locally advanced or borderline resectable pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
Durvalumab and Stereotactic Ablative Body Radiotherapy (SABR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
7 sitesUnited States
Study dates
14 Aug 2020to Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histopathologic or cytologic diagnosis of adenocarcinoma of the pancreas (PDAC), or suspicious for malignancy per pathology, which is deemed BR or LA PDAC per NCCN guidelines or following evaluation by a Multidisciplinary group of physicians.
  • Patients must have received FOLFIRINOX for 3-6 months prior to enrollment with at least stable disease by restaging imaging.
  • Note: SOC treatment regimen derived from FOLFIRINOX dose modifications are acceptable.
  • To maximize potential efficacy no more than a 6-week treatment break is recommended between the completion of SOC chemotherapy (FOLFIRINOX) and initiation of study treatment (durvalumab).
  • Age ≥ 18 years
  • Body weight >30kg
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  • ECOG 0-2
  • Patients must have normal organ and marrow function as defined below:
  • Absolute Neutrophil Count (ANC) ≥1.0 K/mcL
  • Platelets ≥75 K/mcL
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
  • AST(SGOT) and ALT(SGPT) ≤ 2.5 X ULN
  • Creatinine OR creatinine clearance ≤ 1.5 times the upper limit of normal OR > 40 mL/min for patients with creatinine levels above normal.
  • Note: Patients with biliary stent are eligible provided that all other inclusion criteria are met.
  • Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of durvalumab administration or evidence of post-menopausal status. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Non-sterilized male participants who are sexually active with a female partner of childbearing potential must be willing to use a highly effective method of contraception from Day 1 through 90 days after receipt of the final dose of investigational product(s). Not engaging in sexual activity for the total duration of the study and the drug washout period is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male participants must be willing to refrain from sperm donation throughout these periods.
  • Ability to understand and the willingness to sign an informed consent document.
  • Willingness and ability to comply with the protocol including study treatment, scheduled assessments and follow-up.

Who cannot join

  • History of another primary malignancy except for:
  • °Malignancy treated with curative intent with no known active disease for 2 years before the first dose of study drug and low potential risk for recurrence.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Patients who have had prior anti-cancer treatment or are currently receiving anti-cancer treatment for their disease other than chemotherapy as stipulated by protocol.
  • Women who are breastfeeding.
  • Any clinically significant, unresolved toxicity >CTCAE grade 2 from previous anti-cancer therapy with the exception of alopecia, vitiligo and laboratory values defined in the inclusion criteria.
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  • Patients with Grade ≥ 2 neuropathy will be included at the investigator's discretion
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the nvestigator's discretion
  • Patients who are currently receiving any other investigational agents for therapeutic treatment of their primary cancer.
  • Any previous treatment with a PD1 or PD-L1 inhibitor, including Durvalumab or other immunotherapy.
  • Known metastatic disease.
  • Major surgical procedures based on clinical judgement of the investigator within 30 days prior to the first dose of study drug. Patients may undergo staging laparoscopy, PTC placement, ERCP, etc. at any time which should not interfere with study treatment.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients who are receiving radiation treatment outside of the enrolling centers.
  • Patients with frank transmural macroscopic invasion of duodenum by tumor as determined by treating investigator.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis, Crohn's disease], diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel syndrome, or other serious gastrointestinal chronic conditions associated with diarrhea); systemic lupus erythematosus; Wegener syndrome (granulomatosis with polyangiitis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis, etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: Patients with vitiligo or alopecia. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement, or psoriasis not requiring systemic treatment
  • Current or prior use of immunosuppressive medication within 28 days before treatment, except with chemotherapy.
  • History of organ transplant that requires use of immunosuppressive agents.
  • History of active primary immunodeficiency.
  • Receipt of live attenuated vaccination within 30 days prior to receiving durvalumab.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings and TB testing in line with local practices), active bleeding diatheses, hepatitis B (known positive HBV surface antigen result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
  • Patient with known active Hepatitis (i.e. Hepatitis B or C).
  • Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg and PCR negative) are eligible.
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Patients with macroscopic invasion of the bowel or stomach submucosa by primary pancreatic tumor as determined by PI.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Phase I/II Study of Durvalumab (Medi 4736) and Stereotactic Ablative Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma

The purpose of this study is to find out if combining durvalumab with standard stereotactic ablative radiotherapy (SABR) is an effective treatment for people with locally advanced or borderline resectable pancreatic cancer. The researchers will also look at the safety of the combination treatment and any side effects it causes.

Being tested
Durvalumab, Stereotactic Ablative Body Radiotherapy (SABR)
Keywords
Stereotactic Ablative Body Radiotherapy (SABR), Durvalumab, 20-228

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    Also called Medi 4736

    Durvalumab will be given 750 mg, intravenously (IV) over 60 minutes (+/- 5 minutes), Q14 days beginning D1. Four doses of durvalumab will be administered on the Q14 day schedule. Subsequently Durvalumab will continue as maintenance 1500mg, intravenously (IV) over 60 minutes (+/- 5 minutes), Q28 days up to 1 year or until progression (11 doses), unacceptable toxicity or other reason. If a patient undergoes resection, they will resume durvalumab once appropriately healed from surgery (approximately 4-8 weeks) at discretion of treating medical oncologist.

  • Stereotactic Ablative Body Radiotherapy (SABR)Radiation

    SABR delivered as 6.6 Gy/fraction x 5 fractions given within two weeks will be administered weekdays and will begin D8.

Study groups in NCT03245541
Study groupRoleWhat they receive
Durvalumab + SABRExperimentalDurvalumab + Stereotactic Ablative Body Radiotherapy
Receives: Drug: Durvalumab; Radiation: Stereotactic Ablative Body Radiotherapy (SABR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with dose limiting toxicities in the first 10 weeks of treatment

    Measured: 10 weeks

  2. Progression Free Survival

    Duration of time from diagnosis to time of progression

    Measured: 12 months

  3. Proportion of participants who have resectable disease

    Based on overall downstaging of disease post-treatment

    Measured: 24 weeks

  4. Progression Free Survival (Phase II)

    From study enrollment to time of progression

    Measured: 6 months

Secondary outcomes (4)

  1. Mean change in levels of inflammatory cytokines from baseline

    As measured from cytokine analysis from serum

    Measured: 10 weeks

  2. Mean change in levels of immune cells from baseline

    As determined from flow cytometry from biopsies and blood

    Measured: 10 weeks

  3. Mean change in protein levels from baseline

    As determined from quantitative immunohistochemistry on biopsy samples

    Measured: 10 weeks

  4. Mean change in microbiome from baseline

    As determined from analysis of stool samples

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2017
  2. Study start14 Aug 2020
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03245541
Sponsor's protocol ID
20-228
Status last verified
Oct 2026
First submitted
7 Aug 2017
Last updated
9 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Durvalumab and Stereotactic Ablative Body Radiotherapy (SABR) in people with Pancreatic Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with dose limiting toxicities in the first 10 weeks of treatment (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03245541.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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