Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal… (NCT02583477) | Clinical Trial Compass
CompletedPhase 1/2
Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal Carcinoma
United States, United Kingdom23 participantsStarted 2016-03-25
Plain-language summary
A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different Combinations (with chemotherapy or AZD5069) in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen or treatment-naïve patients
✓. 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
✓. MEDI4736 + nab-paclitaxel + gemcitabine chemotherapy cohort: treatment-naïve patients with metastatic PDAC who have received no previous systemic chemotherapy 5 MEDI4736 + Cohort: Patient should receive no more than 1 prior systemic chemotherapy regimen.
Exclusion criteria
✕. Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment.
✕. Receipt of any investigational anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
✕. Major surgical procedure within 21 days prior to the first dose of IP.
✕. Patients weighing less than 30 kg
✕. History of leptomeningeal carcinomatosis
✕. Ascites requiring intervention
✕. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy
What they're measuring
1
Number of Participants With Dose-Limiting Toxicities (DLT)
Timeframe: Cohort 1: From time of first dose of MEDI4736 on Day 1 up to Day 28 of Cycle 1 and Cohort 2: From time of first dose of AZD5069 and MEDI4736 on Day 1 up to Day 28 of Cycle 1 or until a participant experiences a DLT, whichever occurs first.
2
Number of Participants With AEs
Timeframe: From first dose of study treatment administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months.
3
Objective Response Rate (ORR) in Cohort 2
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.