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

AstraZeneca logo

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: -

  • 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.

Trial design

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

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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