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Borderline Resectable Pancreatic AdenocarcinomaPhase 2NCT04940286

Gemcitabine, Nab-paclitaxel, Durvalumab, and Oleclumab Before Surgery for the Treatment of in Resectable/Borderline Resectable Primary Pancreatic Cancer

A Phase 2 study testing Durvalumab, Gemcitabine and Nab-paclitaxel in people with Borderline Resectable Pancreatic Adenocarcinoma and Resectable Pancreatic Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site 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

This phase II trial studies the effects of gemcitabine, nab-paclitaxel, durvalumab, and oleclumab in treating patients with primary pancreatic cancer that may be able to be removed by surgery (resectable/borderline resectable). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Durvalumab, Gemcitabine and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
28 Sep 2021to 30 Oct 2027
Phase
Phase 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

  • Capable of giving written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent includes any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
  • Age >= 18 years at time of study entry
  • Has histologically or cytologically confirmed resectable or borderline resectable pancreatic adenocarcinoma per MD Anderson criteria (borderline patients based upon reconstructable superior mesenteric vein/portal vein [SMV/PV] involvement or reconstructable hepatic artery involvement are allowed)
  • Has received no prior anti-cancer therapy for pancreatic adenocarcinoma
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Hemoglobin >= 9.0 g/dL
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  • Absolute neutrophil count 1.5 x (>= 1500 per mm^3)
  • Platelet count >=100 x 10^9/L (>= 100,000 per mm^3)
  • Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician. Subjects requiring biliary decompression, biliary stent, or drainage using percutaneous trans-hepatic cholangiogram are allowed (patients with a declining bilirubin status post stent placement are eligible with serum bilirubin =< 2.5 x institutional ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional ULN
  • Measured creatinine clearance (CL) > 40 mL/min or calculated creatinine CL> 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
  • Has evidence of post-menopausal status or negative urinary- or serum pregnancy test for female, pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women < 50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or if they underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women >= 50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
  • Is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up
  • Must have a predicted life expectancy of at least 6 months
  • Is willing to undergo mandatory research esophagogastroduodenoscopy/endoscopic ultrasound for fine-needle aspiration (exceptions to this eligibility can be discussed with principal investigator [PI] and will be considered on a case-by-case basis)
  • Has body weight of > 35 kg

Who cannot join

  • Participated in another clinical study with an investigational product during the last 4 weeks from the first dose of this study's treatment
  • May need preoperative radiation therapy (as determined per the treating medical team: medical oncologist and/or surgical oncologist at time of study enrollment)
  • Is concurrently enrolled in another clinical study (patient is eligible if the study is an observational (non interventional) study or if enrollment is during the follow-up period of an interventional study
  • Has definitive evidence of metastatic disease per radiographic assessment
  • Is receiving any concurrent chemotherapy, investigational product (IP), or biologic- or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
  • Had a major surgical procedure within 28 days prior to the first dose of IP (PORT placement does not count; if classification is uncertain, discuss with PI)
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  • Has history of allogenic organ transplantation
  • Has an active or previously documented autoimmune or inflammatory disorder (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [diverticulosis is not an excluding factor], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion (and do not exclude patients from participation):
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Patients having any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years (allowed only after consultation with the study physician)
  • Patients with celiac disease controlled by diet alone
  • Has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection; symptomatic congestive heart failure; uncontrolled hypertension; unstable angina pectoris; cardiac arrhythmia; interstitial lung disease; serious chronic gastrointestinal conditions associated with diarrhea; or psychiatric illness/social situations that would limit compliance with study requirements, would substantially increase risk of incurring adverse events (AEs), or would compromise the ability of the patient to give written informed consent
  • Has a history of another primary malignancy. Patients having the following are still eligible:
  • Malignancy treated with curative intent, no known active disease >= 5 years before the first dose of IP, and low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
  • Has a history of leptomeningeal carcinomatosis
  • Has a history of active primary immunodeficiency
  • Has active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (hepatitis C virus [HCV]) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
  • Is currently using or previously used immunosuppressive medication within 14 days before the first dose of durvalumab. The following medications are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication)
  • Has received live attenuated vaccine within 30 days prior to the first dose of IP. Note: patients, if enrolled, should not receive live vaccine while receiving IP or during the 30 days after the last dose of IP
  • Is a female and pregnant or breastfeeding; or is a male or female of reproductive potential who is not willing to employ effective birth control from time of screening to 90 days after the last dose of durvalumab and oleclumab monotherapy
  • Has a known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
  • Previously received clinical-trial treatment with durvalumab or oleclumab regardless of treatment arm assignment
  • Has laboratory evidence of hypercalcemia (>= 11 mg/dL [in presence of normal albumin]) and/or hyperphosphatemia (>= 5.5 mg/dL)
  • Has a history of venous thrombosis within the past 3 months prior to scheduled first dose of study treatment and is not receiving fully dosed anticoagulation; or has symptomatic venous thrombosis and symptoms have not improved
  • Has a prior history of myocardial infarction, transient ischemic attack, or stroke within the past 3 months prior to the scheduled first dose of study treatment
  • Is unsuitable to participate in the study or is unlikely to comply with study procedures, restrictions and requirements (per judgment by the investigator)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Study of Neoadjuvant Gemcitabine, Nab-paclitaxel, Durvalumab (MEDI4736) (Anti-PD-L1), and Oleclumab (Anti-CD73) in the Treatment of Resectable/Borderline Resectable Primary Pancreatic Adenocarcinoma

This phase II trial studies the effects of gemcitabine, nab-paclitaxel, durvalumab, and oleclumab in treating patients with primary pancreatic cancer that may be able to be removed by surgery (resectable/borderline resectable). Chemotherapy drugs, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and oleclumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving gemcitabine, nab-paclitaxel, durvalumab, and oleclumab may help control the disease in patients with resectable/borderline resectable primary pancreatic cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Estimation of major pathological response (MPR) rate (=< 5% viable tumor cells).

II. Assess the safety of combining immunotherapy (durvalumab and oleclumab) with gemcitabine/nab-paclitaxel as neoadjuvant therapy.

EXPLORATORY OBJECTIVES:

  1. Explore the changes in various immune parameters, including PD-L1 and PD-1 expression in the tumor, during treatment and correlate with efficacy outcomes with the goal of biomarker discovery.

II. Radiographic response rate and CA19-9 response to neoadjuvant therapy. III. Estimate the relapse-free survival (RFS) and overall survival (OS) in enrolled subjects who undergo surgical resection.

IV. Estimate the frequency of intraoperative and postoperative complications in these patients treated with neoadjuvant therapy.

  1. Impact of adjuvant durvalumab/oleclumab +/- gemcitabine/nab-paclitaxel on circulating tumor-derived deoxyribonucleic acid (ctDNA) kinetics.

OUTLINE:

Patients receive durvalumab intravenously (IV) over 1 hour on day 1, oleclumab IV over 1 hour, nab-paclitaxel IV, and gemcitabine IV over 1 hour over 30-40 minutes on days 1 and 15. Treatment repeats every 28 days for 2-6 cycles. Within 4-8 weeks after completion of last cycle of treatment, patients undergo surgical resection. After surgical resection, patient may receive adjuvant therapy with durvalumab and oleclumab, durvalumab, oleclumab, gemcitabine, and nab-paclitaxel, other chemotherapy, or observation only at the discretion of the treating physician.

After completion of study treatment, patients are followed up 28 days and then every 3 months for up to 2 years.

Being tested
Durvalumab, Gemcitabine, Nab-paclitaxel, Oleclumab
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • DurvalumabBiological

    Also called Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736

    Given IV

  • GemcitabineDrug

    Also called dFdC, dFdCyd, Difluorodeoxycytidine

    Given IV

  • Nab-paclitaxelDrug

    Also called ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel

    Given IV

  • OleclumabBiological

    Also called Anti-CD73 Monoclonal Antibody MEDI9447, MEDI9447

    Given IV

Study groups in NCT04940286
Study groupRoleWhat they receive
Treatment (durvalumab, oleclumab, nab-paclitaxel, gemcitabine)ExperimentalPatients receive durvalumab IV over 1 hour on day 1, oleclumab IV over 1 hour, nab-paclitaxel IV, and gemcitabine IV over 1 hour over 30-40 minutes on days 1 and 15. Treatment repeats every 28 days for 2-6 cycles. Within 4-8 weeks after completion of last cycle of treatment, patients undergo surgical resection. After surgical resection, patient may receive adjuvant therapy with durvalumab and oleclumab, durvalumab, oleclumab, gemcitabine, and nab-paclitaxel, other chemotherapy, or observation only at the discretion of the treating physician.
Receives: Biological: Durvalumab; Drug: Gemcitabine; Drug: Nab-paclitaxel; Biological: Oleclumab

What is being measured

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

  1. Major pathological response rate (=< 5% viable tumor cells)

    A Chi square- or Fisher's exact test will be used to evaluate the association between patient prognostic factor and response. Paired t-tests will be used to determine parameter changes before and after surgery in various immune-based conditions.

    Measured: Up to 2 years

  2. Incidence of adverse events

    Assessed using the Common Terminology Criteria for Adverse Events Version 5.0.

    Measured: Up to 2 years

Timeline

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

  1. First posted25 Jun 2021
  2. Study start28 Sep 2021
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Oct 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04940286
Sponsor's protocol ID
2020-0898
Other IDs
NCI-2021-05721, 2020-0898
Status last verified
Oct 2026
First submitted
18 Jun 2021
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab, Gemcitabine and Nab-paclitaxel in people with Borderline Resectable Pancreatic Adenocarcinoma and Resectable Pancreatic Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site 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 18 inclusion and 33 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 7 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 1 site 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 phase mean?

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?

Major pathological response rate (=< 5% viable tumor cells) (time frame: Up to 2 years). The study lists 2 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 NCT04940286.

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 7 Oct 2026.

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