Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic Cancer

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Brief Title

Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic Cancer

Official Title

Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic Cancer

Brief Summary

       The dynamics of immune cells by CCRT/Durvalumab will be uncovered. The
      combination of Durvalumab with concurrent chemoradiotherapy (CCRT/gemcitabine)) as neoaduvant
      treatment in resectable or borderline resectable pancreatic cancer is feasible and
      efficacious.

      The combination of Durvalumab with cytotoxic chemotherapy (gemcitabine) as an adjuvant
      treatment is feasible and efficacious.

       To assess the effect of Neoadjuvant CCRT with Gemcitabine/Durvalumab followed by
      adjuvant Gemcitabine/Durvalumab in resectable or borderline resectable pancreatic cancer

      Primary endpoint:

      2 year-DFSR (disease-free survival rate) Secondary endpoints

        -  Efficacy: 2 year-OSR (overall survival rate), disease-free survival, overall survival,
           overall response rate (RECIST 1.1, ir response) after neoadjuvant CCRT, disease control
           rateEORTC QLQ-C30, the number of immune cells (TIL, macrophage, etc) in resected
           pancreatic tissue

        -  Safety: toxicity (CTCAE V), irAE,

      Exploratory Objective(s):

        -  To evaluate baseline measures and changes of immune systems and regulations by
           neoadjuvant CCRT with gemcitabine/Durvalumab in peripheral blood and tumor tissues

        -  To collect and store DNA from blood (according to ethical procedures) for future
           exploratory research into genes/genetic variation that may influence response (ie,
           distribution, safety, tolerability and efficacy) to study treatments and or
           susceptibility to disease (optional).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Disease-free survival rate

Secondary Outcome

 Overall survival

Condition

Pancreatic Cancer

Intervention

Gemcitabine

Study Arms / Comparison Groups

 Gemcitbine/Durvalumab
Description:  Neoadjuvant CCRT with Gemcitbine/Durvalumab
+Adjuvant Gemcitabine/Durvalumab Total 6 cycles, after that, Durvalumab q4wks up to total 1 year

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

71

Start Date

November 29, 2018

Completion Date

November 30, 2021

Primary Completion Date

November 30, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Written informed consent and any locally-required authorization (eg, HIPAA in the USA,
             EU Data Privacy Directive in the EU) obtained from the subject prior to performing any
             protocol-related procedures, including screening evaluations

          2. Age>=19 years at time of study entry

          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          4. Life expectancy of >= 3months

          5. Histologically proven pancreatic ductal adenocarcinoma

          6. Resectable or borderline resectable based on AJCC Cancer staging system (8th ed)

          7. Chemotherapy -naïve for their pancreatic cancer

          8. Body weight >30kg (for durvalumab monotherapy or durvalumab + novel)

          9. Adequate normal organ and marrow function as defined below: (NOTE TO AUTHOR: These are
             minimum criteria for studies in subjects with solid tumors and may need to be altered
             based on individual study requirements; please adjust as necessary) -Haemoglobin ≥ 9.0
             g/dL

               -  Absolute neutrophil count (ANC) 1.5 (or 1.0) x (> 1500 per mm3)

               -  Platelet count ≥ 100 (or 75) x 109/L (>75,000 per mm3)

               -  Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not
                  apply to subjects 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.

               -  AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver
                  metastases are present, in which case it must be ≤ 5x ULN

               -  Serum 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:

         10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for
             female pre-menopausal subjects. Women will be considered post-menopausal if they have
             been amenorrheic for 12 months without an alternative medical cause. The following
             age-specific requirements apply:

         11. Subject 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.

        Exclusion Criteria:

        25. Participation in another clinical study with an investigational product during the last
        3 weeks 26. Concurrent enrolment in another clinical study, unless it is an observational
        (non-interventional) clinical study or during the follow-up period of an interventional
        study 27. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab 28.
        Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine
        therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies,
        other investigational agent) 28 days prior to the first dose of study drug 29. Mean QT
        interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs)
        using Fridericia's Correction (this can be removed if testing durvalumab alone and retain
        this exclusion if combining durvalumab with novel agents) 30. Current or prior use of
        immunosuppressive medication within 14days (use 28 days if combining durvalumab with a
        novel agent) before the first dose of durvalumab, with the exceptions of intranasal and
        inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not
        to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. The following are
        exceptions to this criterion:

        - Intranasal, inhaled, topical steroids, or local steroid injections (eg, 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 (eg, CT scan premedication)
             31. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with
             the exception of alopecia, vitiligo, and the laboratory values defined in the
             inclusion criteria

          -  Subjects with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after
             consultation with the Study Physician.

          -  Subjects with irreversible toxicity not reasonably expected to be exacerbated by
             treatment with durvalumab may be included only after consultation with the Study
             Physician.

             32. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer
             treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg,
             hormone replacement therapy) is acceptable. <> 33. <>Radiotherapy treatment to more than 30% of the bone marrow or with a wide field
             of radiation within 4 weeks of the first dose of study drug 34. Major surgical
             procedure (as defined by the Investigator) within 28 days prior to the first dose of
             IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.

             35. History of allogenic organ transplantation. 36. Active or prior documented
             autoimmune or inflammatory disorders (including inflammatory bowel disease [eg,
             colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis],
             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:

          -  Subjects with vitiligo or alopecia

          -  Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone
             replacement

          -  Any chronic skin condition that does not require systemic therapy

          -  Subjects without active disease in the last 5 years may be included but only after
             consultation with the study physician

          -  Subjects with celiac disease controlled by diet alone 37. 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 requirement, substantially increase risk of incurring AEs or
             compromise the ability of the patient to give written informed consent 38. History of
             another primary malignancy except for

          -  Malignancy treated with curative intent and with no known active disease ≥5 years
             before the first dose of IP and of 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 39. History of
             leptomeningeal carcinomatosis 40. Brain metastases or spinal cord compression. 41.
             Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms
             calculated from 3 ECGs (within 15 minutes at 5 minutes apart) <>.

             42. History of active primary immunodeficiency 43. Active infection including
             tuberculosis (clinical evaluation that includes clinical history, physical examination
             and radiographic findings, and TB testing in line with local practice), hepatitis B
             (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human
             immunodeficiency virus (positive HIV 1/2 antibodies). Subjects with a past or resolved
             HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and
             absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are
             eligible only if polymerase chain reaction is negative for HCV RNA.

             44. Current or prior use of immunosuppressive medication within 14 days before the
             first dose of durvalumab or tremelimumab. The following are exceptions to this
             criterion:

          -  Intranasal, inhaled, topical steroids, or local steroid injections (eg, 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 (eg, CT scan premedication)
             45. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
             Note: Subjects, if enrolled, should not receive live vaccine whilst receiving IP and
             up to 30 days after the last dose of IP.

             46. Female subjects who are pregnant or breastfeeding or male or female subjects of
             reproductive potential who are not willing to employ effective birth control from
             screening to 90 days after the last dose of durvalumab monotherapy.

             47. Known allergy or hypersensitivity to any of the study drugs or any of the study
             drug excipients.

             48. Prior randomisation or treatment in a previous durvalumab and/or tremelimumab
             clinical study regardless of treatment arm assignment.

             49. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which
             required steroid treatment, or any evidence of clinically active interstitial lung
             disease.

             50. Judgment by the investigator that the patient is unsuitable to participate in the
             study and the patient is unlikely to comply with study procedures, restrictions and
             requirements.
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Do-Youn Oh, MD, PhD, 82-2-2072-0701, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT03572400

Organization ID

ESR-16-12315


Responsible Party

Sponsor-Investigator

Study Sponsor

Do-Youn Oh

Collaborators

 AstraZeneca

Study Sponsor

Do-Youn Oh, MD, PhD, Principal Investigator, Seoul National University Hospital


Verification Date

September 2019