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

  • STATUS
    Recruiting
  • days left to enroll
    66
  • participants needed
    71
  • sponsor
    Do-Youn Oh
Updated on 24 March 2021
ct scan
platelet count
corticosteroids
carcinoma
chemoradiotherapy
neutrophil count
gemcitabine
cancer chemotherapy
adenocarcinoma
antineoplastic
solid tumour
celiac
immunostimulant
resectable pancreatic cancer
pancreatic ductal adenocarcinoma
breast ductal carcinoma

Summary

<Research Hypothesis> 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.

<Objectives> 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).

Details
Condition Pancreatic Cancer, Pancreatic disorder, Neoplasm of unspecified nature of digestive system, Pancreatic Disorders, Islet Ce417ll Cancer, Digestive System Neoplasms, cancer of the pancreas, pancreatic cancers, cancer, pancreatic
Treatment Gemcitabine, durvalumab
Clinical Study IdentifierNCT03572400
SponsorDo-Youn Oh
Last Modified on24 March 2021

Eligibility

Yes No Not Sure

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. <<amend as required based on any combination studies with other anti-cancer agents>> 33\. <<if applicable to the study>>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) <<for durvalumab monotherapy and durvalumab + tremelimumab combination studies this criterion can be removed. For durvalumab tremelimumab in combination with an agent with pro-arrhythmic potential or where effect of the combination on QT is not known if this criterion should be retained. Patient safety and the cardiac SKG should be consulted as needed>>. 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

Exclusion Criteria

\. 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
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