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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma

Treatments: Drug: tremelimumab+MEDI4736; Drug: MEDI4736 monotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02558894

D4198C00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

MEDI4736 monotherapy

Experimental group

Description:

MEDI4736 via IV infusion.

Treatment:

Drug: MEDI4736 monotherapy

tremelimumab+MEDI4736

Experimental group

Description:

MEDI4736+tremelimumab via IV infusion.

Treatment:

Drug: tremelimumab+MEDI4736