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A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies

NCT02963831 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2022-12-22

Study results available
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Summary

This is a two-part Phase 1/2 dose escalation and dose expansion study of an Adenovirus Vector (Ad5/3-D24-GMCSF), Expressing GM-CSF (GM-CSF-encoding adenovirus), ONCOS-102, in combination with anti-programmed death ligand-1 (PD-L1) antibody, durvalumab, in adult subjects with peritoneal disease who have failed prior standard chemotherapy and have histologically confirmed epithelial ovarian cancer or metastatic colorectal cancer.

Conditions

Interventions

BIOLOGICAL

ONCOS-102

ONCOS-102 was administered by intraperitoneal infusion at weekly intervals for 6 weeks.

DRUG

Durvalumab

Durvalumab was administered by IV infusion once every four weeks for a total of 10 (Cohort A) or 12 four-week cycles.

DRUG

Cyclophosphamide

A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102.

Sponsors & Collaborators

  • Cancer Research Institute, New York City

    collaborator OTHER

  • MedImmune LLC

    collaborator INDUSTRY

  • Targovax ASA

    collaborator INDUSTRY

  • Ludwig Institute for Cancer Research

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-07
Primary Completion
2022-06-25
Completion
2022-06-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02963831 on ClinicalTrials.gov