A Randomised Phase II Open-label Study With a Phase Ib Safety lead-in Cohort of ONCOS-102, an Immune-priming GM-CSF Coding Oncolytic Adenovirus, and Pemetrexed/Cisplatin in Patients With Unresectable Malignant Pleural Mesothelioma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02879669 |
Recruitment Status :
Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : October 8, 2020
|
Sponsor:
Targovax Oy
Collaborator:
Theradex
Information provided by (Responsible Party):
Targovax ASA ( Targovax Oy )
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | July 13, 2016 | ||
First Posted Date ICMJE | August 26, 2016 | ||
Last Update Posted Date | October 8, 2020 | ||
Study Start Date ICMJE | June 2016 | ||
Actual Primary Completion Date | May 2020 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Number of patients with any (Serious and Non-Serious) Adverse Event measured to assess safety and tolerability [ Time Frame: 6 months ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
|
||
Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Randomised Phase II Open-label Study With a Phase Ib Safety lead-in Cohort of ONCOS-102, an Immune-priming GM-CSF Coding Oncolytic Adenovirus, and Pemetrexed/Cisplatin in Patients With Unresectable Malignant Pleural Mesothelioma | ||
Official Title ICMJE | A Randomised Phase II Open-label Study With a Phase Ib Safety lead-in Cohort of ONCOS-102, an Immune-priming GM-CSF Coding Oncolytic Adenovirus, and Pemetrexed/Cisplatin in Patients With Unresectable Malignant Pleural Mesothelioma | ||
Brief Summary | The trial is an open-label, parallel group, multicentre trial that will recruit a total of 30 patients with malignant pleural mesothelioma. The trial will be conducted in 2 phases: a non-randomised safety phase and a randomised phase. The safety phase will consist of a lead-in cohort of 6 patients treated with ONCOS 102 and pemetrexed/cisplatin. The randomised phase will not commence until the DSMB has deemed the safety lead-in data appropriate for continuation. A total of 24 patients will be included in the randomised phase; 14 patients will be randomised to receive ONCOS 102 and pemetrexed/cisplatin, and 10 patients will receive pemetrexed/cisplatin alone. If cisplatin is seen to be too toxic after one or more cycles, the patient may change to carboplatin during the study. Furthermore, if treatment with cisplatin is deemed to be too toxic by the investigator due to age, presence of neurological toxicities or other relevant medical conditions, carboplatin can be administered from start of study. The trial's main objectives are determination of safety, immune activation, clinical response and the correlation between clinical outcome and the immunological data. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 Phase 2 |
||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||
Condition ICMJE | To Determine Safety, Tolerability and Efficacy of ONCOS-102 in Combination With Chemotherapy | ||
Intervention ICMJE |
|
||
Study Arms ICMJE |
|
||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Active, not recruiting | ||
Actual Enrollment ICMJE |
31 | ||
Original Estimated Enrollment ICMJE |
30 | ||
Study Completion Date ICMJE | Not Provided | ||
Actual Primary Completion Date | May 2020 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
The patient may be evaluated by a multidisciplinary consultation (according to hospital procedure), however the final decision about the inclusion of a patient is made by the principal investigator.
Exclusion Criteria:
|
||
Sex/Gender ICMJE |
|
||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | France, Spain | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02879669 | ||
Other Study ID Numbers ICMJE | ONCOS C719 2015-005143-13 ( EudraCT Number ) |
||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Targovax ASA ( Targovax Oy ) | ||
Study Sponsor ICMJE | Targovax Oy | ||
Collaborators ICMJE | Theradex | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Targovax ASA | ||
Verification Date | October 2020 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |