Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT02954991 |
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Recruitment Status :
Completed
First Posted : November 4, 2016
Last Update Posted : November 4, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Drug: Glesatinib Drug: Sitravatinib Drug: Mocetinostat Drug: Nivolumab | Phase 2 |
Glesatinib is an orally administered multi-targeted tyrosine kinase inhibitor (TKI) that primarily targets the Axl and Mesenchymal-Epithelial Transition (MET) receptors. Sitravatinib is an orally-available, potent small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, Axl, MERTK, VEGFR family, PDGFR family, KIT, FLT3, Trk family, RET, DDR2 and selected Eph family members. Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Nivolumab is a human IgG monoclonal antibody that binds to the programmed cell death-1(PD-1) receptor and blocks its interaction with programmed cell death ligand-1 (PD-L1) and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response including anti-tumor immune response. Combining an immunotherapeutic PD-L1 checkpoint inhibitor with an agent that has both immune modulatory and antitumor properties could enhance the antitumor efficacy observed with either agent alone.
The study will begin with a lead-in dose escalation evaluation of two dose levels of each investigational agent in combination with nivolumab. Following completion of the lead-in dose escalation, enrollment into the Phase 2 study will proceed.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 211 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Parallel Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Advanced or Metastatic Non-Small Cell Lung Cancer |
| Actual Study Start Date : | November 7, 2016 |
| Actual Primary Completion Date : | November 4, 2021 |
| Actual Study Completion Date : | November 4, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Glesatinib and Nivolumab
Glesatinib oral tablet administered twice daily in combination with Nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week
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Drug: Glesatinib
Glesatinib is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Other Name: MGCD265 Drug: Nivolumab nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Other Name: Opdivo |
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Experimental: Sitravatinib and Nivolumab
Sitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week
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Drug: Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Other Name: MGCD516 Drug: Nivolumab nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Other Name: Opdivo |
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Experimental: Mocetinostat and Nivolumab
Mocetinostat oral capsule administered three times weekly in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 week
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Drug: Mocetinostat
Mocetinostat is an HDAC inhibitor.
Other Name: MGCD01013 Drug: Nivolumab nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Other Name: Opdivo |
- Number of patients experiencing tumor size reduction [ Time Frame: Approximately 8 months ]
- Number of patients experiencing adverse events [ Time Frame: up to 12 months ]
- Blood plasma concentration of the investigational agent [ Time Frame: Up to 20 weeks ]
- Overall Survival [ Time Frame: Up to 24 months ]
- Progression free survival [ Time Frame: Up to 12 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of non-small cell lung cancer.
- Prior treatment with a checkpoint inhibitor (as appropriate per cohort)
- Adequate bone marrow and organ function
Exclusion Criteria:
- Uncontrolled tumor in the brain
- Unacceptable toxicity with prior checkpoint inhibitor
- Impaired heart function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954991
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| Responsible Party: | Mirati Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT02954991 |
| Other Study ID Numbers: |
MRTX-500 |
| First Posted: | November 4, 2016 Key Record Dates |
| Last Update Posted: | November 4, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Nivolumab Mocetinostat Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Histone Deacetylase Inhibitors Enzyme Inhibitors |