Clinical trial NCT02558894: Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma
Official title: A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination With Tremelimumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
Keywords: Pancreatic Ductal Adenocarcinoma, PDAC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.

Detailed description: This is a Phase II, open-label, multi-center study to determine the efficacy and safety of MEDI4736 evaluated as single agent or in combination with tremelimumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed on fluoropyrimidine containing or gemcitabine-containing first-line chemotherapy.This study will consist of Part A, lead-in, as well as a possible expansion Part B.

Eligibility criteria: Inclusion Criteria: -

1. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen
2. Eastern Cooperative Oncology Group 0 or 1
3. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) scan and that is suitable for accurate repeated measurements

Exclusion Criteria:

1. Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment.
2. History of leptomeningeal carcinomatosis
3. Ascites requiring intervention
4. Brain metastases or spinal cord compression.

Primary outcomes:
measure: Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)
Secondary outcomes:
measure: Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1
timeFrame: From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)
measure: PFS Rate at 3 Months and at 6 Months
timeFrame: From date of first infusion until confirmed disease progression or death (up to 3 months and 6 months)
measure: Overall Survival (OS)
timeFrame: From date of first infusion until death (up to approximately 18 months for the data analysis cut-off)
measure: Survival Status, Presented as OS Rate, at 6 Months and at 12 Months
timeFrame: From date of first infusion until death (up to 6 months and 12 months)
measure: Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1
timeFrame: From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)
measure: Disease Control Rate (DCR) Using Investigator Assessments According to RECIST 1.1
timeFrame: From date of first infusion until confirmed disease progression or death (up to 3 months, 6 months and 12 months)
measure: Pharmacokinetics (PK) of Durvalumab (MEDI4736)
timeFrame: Blood samples were collected pre-dose on Day 1 (Week 0), Week 4, Week 12 and Week 24, post-dose on Day 1, Week 12 and Week 24, and additionally at 3 months after the last dose (follow-up).
measure: PK of Tremelimumab
timeFrame: Blood samples were collected pre-dose on Day 1 (Week 0), Week 4 and Week 12, post-dose on Day 1 and Week 12, and additionally at 3 months after the last dose (follow-up).
measure: Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736)
timeFrame: Immunogenicity samples were collected on Day 1 (Week 0), Week 4, Week 12 and Week 24, and additionally at 3 months and 6 months after the last dose (follow-up).
measure: Presence of ADAs for Tremelimumab
timeFrame: Immunogenicity samples were collected on Day 1 (Week 0), Week 4 and Week 12, and additionally at 3 months and 6 months after the last dose (follow-up).
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Research Site
state: Florida
city: New York
country: United States
facility: Research Site
state: New York
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Friedrichshafen
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Tuebingen
country: Germany
facility: Research Site
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center, 300 East 66th Street,New York,NY 10065
name: Eileen M O'Reilly, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Reilly EM, Oh DY, Dhani N, Renouf DJ, Lee MA, Sun W, Fisher G, Hezel A, Chang SC, Vlahovic G, Takahashi O, Yang Y, Fitts D, Philip PA. Durvalumab With or Without Tremelimumab for Patients With Metastatic Pancreatic Ductal Adenocarcinoma: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Oct 1;5(10):1431-1438. doi: 10.1001/jamaoncol.2019.1588.