Study of MEDI4736, when used alone or in combination with Tremelimumab, as second line chemotherapy in metastatic Pancreatic Ductal Adenocarcinoma

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 - ALPS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002001-11-DE

Enrollment

130

Registered

2015-09-28

Start date

2015-12-22

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients (aged =18 years) with histologically or cytologically confirmed metastatic PDAC, and had tumor progression following prior standard first-line 5-FU-containing or gemcitabine-containing chemotherapy. MedDRA version: 18.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864

Interventions

Product Name: MEDI4736 Product Code: MEDI4736 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: durvalumab CAS Number: 1428935-60-7 Current Sponsor code: MEDI4736 Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen 2. ECOG 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 91 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 39

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): 1.Duration of response 2.Disease control rate 3.Progression-free survival (PFS) 4.Progression-free survival2 (second progression) (PFS2) 5.Proportion of patients alive and progression-free after 3 months 6.Proportion of patients alive and progression-free after 6 months 7.Proportion of patients alive at 6 months from randomization/enrollment 8.Proportion of patients alive at 12 months from randomization/enrollment 9.Best objective response;Timepoint(s) of evaluation of this end point: every 6 weeks for the first 48 weeks and then every 12 weeks until confirmed objective disease progression.	—

Measure

Time frame

Secondary end point(s): 1.Duration of response 2.Disease control rate 3.Progression-free survival (PFS) 4.Progression-free survival2 (second progression) (PFS2) 5.Proportion of patients alive and progression-free after 3 months 6.Proportion of patients alive and progression-free after 6 months 7.Proportion of patients alive at 6 months from randomization/enrollment 8.Proportion of patients alive at 12 months from randomization/enrollment 9.Best objective response;Timepoint(s) of evaluation of this end point: every 6 weeks for the first 48 weeks and then every 12 weeks until confirmed objective disease progression.

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Primary

Measure	Time frame
Main Objective: To assess the efficacy of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy in terms of objective response rate;Secondary Objective: 1.To further assess the efficacy of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy compared to SoC in terms of ORR, DoR, DCR, PFS, 2.To investigate the immunogenicity of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy 3.To assess PK of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy;Primary end point(s): Objective response rate ;Timepoint(s) of evaluation of this end point: RECIST assessment will be every 6 weeks for the first 48 weeks and then every 12 weeks until confirmed objective disease progression.	—

Measure

Time frame

Main Objective: To assess the efficacy of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy in terms of objective response rate;Secondary Objective: 1.To further assess the efficacy of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy compared to SoC in terms of ORR, DoR, DCR, PFS, 2.To investigate the immunogenicity of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy 3.To assess PK of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy;Primary end point(s): Objective response rate ;Timepoint(s) of evaluation of this end point: RECIST assessment will be every 6 weeks for the first 48 weeks and then every 12 weeks until confirmed objective disease progression.

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Countries

Canada, Germany, Japan, Korea, Republic of, Netherlands, Spain, United States

Contacts

Public ContactInformation Center

AstraZenenca

information.center@astrazeneca.com0018002369933

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026