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出境医 / 临床实验 / MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma
MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma
Study Description
Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Pleural Mesothelioma | Drug: MTG201 Drug: Nivolumab Injection [Opdivo] | Phase 2 |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 12 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Single arm, open-label |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma |
| Actual Study Start Date : | August 15, 2019 |
| Estimated Primary Completion Date : | September 20, 2020 |
| Estimated Study Completion Date : | December 20, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: MTG201 plus Nivolumab
Single arm, open-label, patients receive both MTG201 and nivolumab
|
Drug: MTG201
MTG201, 3 x 10E12 vp delivered by intratumoral injection on days 1, 8, 22 and 50
Drug: Nivolumab Injection [Opdivo] Nivolumab 480 mg by IV infusion every 4 weeks
|
Outcome Measures
Primary Outcome Measures :
- Objective response rate (ORR) [ Time Frame: 3 months-2 years ]Percentage of subjects with complete or partial response
Secondary Outcome Measures :
- duration of response (DUR) [ Time Frame: up to 2 years ]measured from first observation of response to disease progression
- progression free survival (PFS) [ Time Frame: up to 2 years ]measured from start of study to date of progression or death
Other Outcome Measures:
- Incidence of adverse events [ Time Frame: up to 2 years ]description of adverse events by frequency, severity and causality
- change from baseline in liver transaminases [ Time Frame: up to 2 years ]changes in liver transaminases from prior to first study drug treatment to various timepoints throughout the treatment and follow-up period
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Contacts
| Contact: Ann Lowe, MD | 512-502-5353 | amlowe@earthlink.net | |
| Contact: Lolita Sweidan | 847-254-9633 | Lolita.Sweidan@yourencore.com |
Locations
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Bryan M Burt, MD 713-798-6376 Bryan.Burt@bcm.edu | |
| Contact: Michelle Almarez, BBA 713-798-3680 michelle.almarez@bcm.edu | |
Sponsors and Collaborators
Momotaro-Gene Inc.
Baylor College of Medicine
Synteract, Inc.
Investigators
| Principal Investigator: | Bryan Burt, MD | Baylor College of Medicine Thoracic Surgery |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 24, 2019 | ||||||||
| First Posted Date ICMJE | July 9, 2019 | ||||||||
| Last Update Posted Date | October 8, 2019 | ||||||||
| Actual Study Start Date ICMJE | August 15, 2019 | ||||||||
| Estimated Primary Completion Date | September 20, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Objective response rate (ORR) [ Time Frame: 3 months-2 years ] Percentage of subjects with complete or partial response
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma | ||||||||
| Official Title ICMJE | A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma | ||||||||
| Brief 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. 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single arm, open-label Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Malignant Pleural Mesothelioma | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: MTG201 plus Nivolumab
Single arm, open-label, patients receive both MTG201 and nivolumab
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
12 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 20, 2021 | ||||||||
| Estimated Primary Completion Date | September 20, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04013334 | ||||||||
| Other Study ID Numbers ICMJE | MTG201-MPM-001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Momotaro-Gene Inc. | ||||||||
| Study Sponsor ICMJE | Momotaro-Gene Inc. | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Momotaro-Gene Inc. | ||||||||
| Verification Date | July 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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