Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma

Summary

This is a dual arm, open label phase I/II study to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease. Patients with metastatic colorectal or pancreatic adenocarcinoma who still have an adequate performance status and normal hepatic and renal function will be eligible.

Conditions

• Metastatic Colorectal Cancer
• Colorectal Adenocarcinoma
• Pancreatic Adenocarcinoma
• Metastatic Pancreatic Cancer

Interventions

DRUG

Durvalumab

750mg IV q2 weeks

BIOLOGICAL

CV301

MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c.

DRUG

Capecitabine

1000mg orally twice a day, Monday - Friday Weekly

DRUG

Bevacizumab

5mg/kg IV q2weeks

Sponsors & Collaborators

• Mayo Clinic

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Emory University

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• George Mason University

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• MedImmune LLC

  collaborator INDUSTRY

• Bavarian Nordic

  collaborator INDUSTRY

• Georgetown University

  lead OTHER

Principal Investigators

• Michael Pishvaian, MD PhD · Johns Hopkins University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-08

Primary Completion

2021-08-30

Completion

2023-08-01

FDA Drug

Yes

Countries

• United States

Study Locations