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NCT02963831 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.

Completed
Registry status
Phase 1
Development phase
67
Enrollment target

NCT02963831: Completed Phase 1 study, sponsored by Ludwig Institute for Cancer Research.

NCT02963831 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02963831, a Phase 1 study, has completed, sponsored by Ludwig Institute for Cancer Research.

COMPLETED
Registry status
Phase 1
Development phase
67 participants
Enrollment target

Study 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.

Primary Outcome

All Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 19.0 and classified by MedDRA system organ class (SOC) and preferred term. The severity of AEs was assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject

Interventions

  • DRUG Cyclophosphamide
  • DRUG Durvalumab
  • BIOLOGICAL ONCOS-102

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2017-09-07
Est. Completion 2022-06-25
Phase Phase 1

What the finished NCT02963831 record still lists

NCT02963831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).

The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.

NCT02963831 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02963831 about?

NCT02963831 is a clinical study titled "A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies". 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 h...

What is the current status of trial NCT02963831?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2017-09-07. Estimated completion is 2022-06-25.

What interventions are being tested in trial NCT02963831?

The interventions under investigation include: Cyclophosphamide (DRUG), Durvalumab (DRUG), ONCOS-102 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02963831?

This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02963831's enrollment target sits among peer trials

67 782nd of 2000 higher than 1,215 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02963831, the US trial registry maintained by the National Library of Medicine. NCT02963831 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.