Malignant Pleural MesotheliomaPhase 2NCT04013334
MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma
A Phase 2 study testing MTG201 and Nivolumab Injection [Opdivo] in people with Malignant Pleural Mesothelioma, run by Momotaro-Gene Inc. at 1 site in United States.
Trial summary
Twelve patients with relapsed malignant pleural mesothelioma will be treated with intratumoral injections of MTG201, a replication incompetent adenovirus, modified by the insertion of the reduced expression in immortalized cells (REIC)/Dikkopf (Dkk)-3 gene, on Days 1, 8, 22, and 50. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- MTG201 and Nivolumab Injection [Opdivo]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 1 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed locally advanced or metastatic pleural mesothelioma
- Failed one prior treatment regimen including cisplatin-based chemotherapy
- Eastern cooperative oncology group (ECOG) performance status; 0,1
- Adequate organ function
- Measurable disease per RECIST
Who cannot join
- Candidate for surgical resection
- has active autoimmune disease, primary or acquired immunodeficiency
- significant cardiovascular disease
- has active interstitial lung disease
- has active infection or HIV, hepatitis B or C
- previous anti-PD-1, PD-L1 or CTLA-4 inhibitor immunotherapy
- other clinical significant disorder that could affect conduct of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma
Twelve patients with relapsed malignant pleural mesothelioma will be treated with intratumoral injections of MTG201, a replication incompetent adenovirus, modified by the insertion of the reduced expression in immortalized cells (REIC)/Dikkopf (Dkk)-3 gene, on Days 1, 8, 22, and 50. Patients will also receive every 4 weekly intravenous infusions of nivolumab, 480 mg, starting on Day 2. Safety and anti-tumor activity will be monitored at regular intervals throughout the study.
Read the detailed description
This is a study of the efficacy and safety of MTG201 given by intratumoral injection to patients with malignant pleural mesothelioma who have failed front line chemotherapy. Patients will also receive IV infusions of nivolumab every 4 weeks. MTG201 is a replication incompetent adenovirus into which the gene for REIC/Dkk-3 has been inserted. The insertion of this gene has been shown to endow the adenovirus with anti-tumor activity and to result in enhanced anti-tumor immunity.
MTG201, 3 x 10E12 vp, will be given by intratumoral injection on days 1, 8, 22 and 50. Nivolumab, 480 mg, will be given by IV infusion every 4 weeks until progression. Efficacy will be assessed by CT scans at 4 and 12 weeks, then every 3 months. Safety will be assessed by reported adverse events, periodic laboratory assessments, physical exams, vital signs. The pharmacokinetics and pharmacodynamics of MTG201 will be assessed periodically. Tumor biopsy will be obtained on Days 1, 8 and 50 prior to MTG201 administration.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- MTG201, Nivolumab Injection [Opdivo]
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTG201Drug
Also called Ad-SGE-REIC/Dkk-3
MTG201, 3 x 10E12 vp delivered by intratumoral injection on days 1, 8, 22 and 50
Nivolumab Injection [Opdivo]Drug
Also called Opdivo
Nivolumab 480 mg by IV infusion every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| MTG201 plus Nivolumab | Experimental | Single arm, open-label, patients receive both MTG201 and nivolumab Receives: Drug: MTG201; Drug: Nivolumab Injection [Opdivo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Percentage of subjects with complete or partial response
Measured: 3 months-2 years
Secondary outcomes (2)
duration of response (DUR)
measured from first observation of response to disease progression
Measured: up to 2 years
progression free survival (PFS)
measured from start of study to date of progression or death
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start15 Aug 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open-label
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momotaro-Gene Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine, Synteract, Inc.
- Responsible party
- Sponsor
- Investigators
- Bryan Burt, MD, Principal investigator, Baylor College of Medicine Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013334
- Sponsor's protocol ID
- MTG201-MPM-001
- Status last verified
- Jun 2022
- First submitted
- 24 May 2019
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT04013334
- Acronym / sponsor ID
- MTG201-MPM-001
- Conditions
- Malignant Pleural Mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Momotaro-Gene Inc.Industry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine, Synteract, Inc.
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twelve patients with relapsed malignant pleural mesothelioma will be treated with intratumoral injections of MTG201, a replication incompetent adenovirus, modified by the insertion of the reduced expression in immortalized cells (REIC)/Dikkopf (Dkk)-3 gene, on Days 1, 8, 22, and 50. Patients will also receive every 4 weekly intravenous infusions of nivolumab, 480 mg, starting on Day 2. Safety and anti-tumor activity will be monitored at regular intervals throughout the study.
Detailed description
This is a study of the efficacy and safety of MTG201 given by intratumoral injection to patients with malignant pleural mesothelioma who have failed front line chemotherapy. Patients will also receive IV infusions of nivolumab every 4 weeks. MTG201 is a replication incompetent adenovirus into which the gene for REIC/Dkk-3 has been inserted. The insertion of this gene has been shown to endow the adenovirus with anti-tumor activity and to result in enhanced anti-tumor immunity.
MTG201, 3 x 10E12 vp, will be given by intratumoral injection on days 1, 8, 22 and 50. Nivolumab, 480 mg, will be given by IV infusion every 4 weeks until progression. Efficacy will be assessed by CT scans at 4 and 12 weeks, then every 3 months. Safety will be assessed by reported adverse events, periodic laboratory assessments, physical exams, vital signs. The pharmacokinetics and pharmacodynamics of MTG201 will be assessed periodically. Tumor biopsy will be obtained on Days 1, 8 and 50 prior to MTG201 administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open-label
| Arm | Type | Receives |
|---|---|---|
| MTG201 plus Nivolumab | Experimental | Drug: MTG201, Drug: Nivolumab Injection [Opdivo]Single arm, open-label, patients receive both MTG201 and nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed locally advanced or metastatic pleural mesothelioma
- Failed one prior treatment regimen including cisplatin-based chemotherapy
- Eastern cooperative oncology group (ECOG) performance status; 0,1
- Adequate organ function
- Measurable disease per RECIST
Key exclusion criteria (7 listed)
- Candidate for surgical resection
- has active autoimmune disease, primary or acquired immunodeficiency
- significant cardiovascular disease
- has active interstitial lung disease
- has active infection or HIV, hepatitis B or C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTG201Also: Ad-SGE-REIC/Dkk-3MTG201, 3 x 10E12 vp delivered by intratumoral injection on days 1, 8, 22 and 50 | Drug | MTG201 plus Nivolumab |
| Nivolumab Injection [Opdivo]Also: OpdivoNivolumab 480 mg by IV infusion every 4 weeks | Drug | MTG201 plus Nivolumab |
Primary outcome
Objective response rate (ORR)
Time frame: 3 months-2 years
Percentage of subjects with complete or partial response
2 secondary outcomes
duration of response (DUR)
Time frame: up to 2 years
progression free survival (PFS)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Malignant Pleural Mesothelioma
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingPhase 2
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Pleural Mesothelioma, Pleural Diseases
Active, not recruitingPhase 1
Safety and Preliminary Antitumor Activity of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Burt, MD principal investigator
Baylor College of Medicine Thoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTG201 and Nivolumab Injection [Opdivo] in people with Malignant Pleural Mesothelioma, run by Momotaro-Gene Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 3 months-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.