CompletedPhase 2

Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma

United States, Canada65 participantsStarted 2015-11-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen
✓. Eastern Cooperative Oncology Group 0 or 1
✓. 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

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

What they're measuring

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)

Trial details

NCT IDNCT02558894

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-15

Results submitted2018-05-28

View on ClinicalTrials.gov More Metastatic Pancreatic Ductal Adenocarcinoma trials