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

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2015-002001-11-DE
• Date of registration: 28/09/2015
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: Study of MEDI4736, when used alone or in combination with Tremelimumab, as second line chemotherapy in metastatic Pancreatic Ductal Adenocarcinoma
• Scientific 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 - ALPS
• Date of first enrolment: 22/12/2015
• Target sample size: 130
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002001-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Information Center
• Affiliation: AstraZenenca

• Name: Information Center
• Affiliation: AstraZenenca

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: -50

Product Name: Tremelimumab
Product Code: MEDI1123
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tremelimumab
CAS Number: 745013-19-6
Current Sponsor code: MEDI1123
Other descriptive name: MEDI1123
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

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.

Main Objective: To assess the efficacy of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy in terms of objective response rate

Secondary Outcome(s)

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.

Secondary ID(s)

D4198C00001

2015-002001-11-NL

Source(s) of Monetary Support

AstraZenenca AB