Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC

Mirati Therapeutics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg); Drug: Durvalumab - 1500 mg; Drug: Mocetinostat - 90 mg; Drug: Mocetinostat - 70 mg; Drug: Mocetinostat - 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02805660

0103-020

Details and patient eligibility

About

Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor.

This study is evaluating the combination regimen of mocetinostat and durvalumab in participants with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Phase 1-Diagnosis of advanced or metastatic solid tumor; Phase 2-Diagnosis of NSCLC
• Not amenable to treatment with curative intent
• Adequate bone marrow and organ function

Exclusion criteria

• Impaired heart function
• Uncontrolled tumor in the brain
• Other active cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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83 participants in 7 patient groups

Phase 1: Dose Escalation - 50 mg

Experimental group

Description:

The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.

Treatment:

Drug: Mocetinostat - 50 mg

Drug: Durvalumab - 1500 mg

Phase 1: Dose Escalation - 70 mg

Experimental group

Description:

The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.

Treatment:

Drug: Mocetinostat - 70 mg

Drug: Durvalumab - 1500 mg

Phase 1: Dose Escalation - 90 mg

Experimental group

Description:

The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.

Treatment:

Drug: Mocetinostat - 90 mg

Drug: Durvalumab - 1500 mg

Phase 2: Combination Regimen - Cohort 1

Experimental group

Description:

Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.

Treatment:

Drug: Durvalumab - 1500 mg

Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)

Phase 2: Combination Regimen - Cohort 2

Experimental group

Description:

Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.

Treatment:

Drug: Durvalumab - 1500 mg

Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)

Phase 2: Combination Regimen - Cohort 3

Experimental group

Description:

Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.

Treatment:

Drug: Durvalumab - 1500 mg

Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)

Phase 2: Combination Regimen - Cohort 4

Experimental group

Description:

Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.

Treatment:

Drug: Durvalumab - 1500 mg

Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)