Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer

Browse trials for

• Carcinoma, Non-Small-Cell Lung 6,488

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 161 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Lead sponsor

Mirati Therapeutics Inc. is the lead sponsor of 50 studies on the registry; 3 are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 4 (20%) have results posted.

Study arms

• 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

  Drug: Glesatinib · Drug: Nivolumab

• 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

  Drug: Sitravatinib · Drug: Nivolumab

• 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

  Drug: Mocetinostat · Drug: Nivolumab

Interventions

• DrugGlesatinib

  Glesatinib is a small molecule multi-targeted receptor tyrosine kinase inhibitor

  Also known as: MGCD265

• DrugSitravatinib

  Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

  Also known as: MGCD516

• DrugMocetinostat

  Mocetinostat is an HDAC inhibitor.

  Also known as: MGCD01013

• DrugNivolumab

  nivolumab is a programmed death receptor-1 (PD-1) blocking antibody

  Also known as: Opdivo

Primary outcomes

1. Objective Response Rate (ORR) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

   ORR is defined as the percentage of participants that were documented to have a confirmed complete response (CR) or partial response (PR) as defined by RECIST v1.1.

   Time frame: Up to 40.6 months

Secondary outcomes

1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

   TEAEs were defined as any event that first occur or increase in severity on or after the first dose of study treatment and not more than 28 days after the last dose of study treatment and prior to the initiation of subsequent systemic anti- cancer therapy. Any clinically significant changes in laboratory tests were recorded as TEAEs.

   Time frame: Day 1 up to 28 days after the last dose (median time on treatment was: CIT experienced 3.7 months; CIT naïve 4.8 months)

2. Duration of Response (DOR)

   DOR was defined as the time in months from date of the first documentation of objective response (CR or PR) to the first documentation of objective progressive disease (PD) or to death due to any cause in the absence of documented PD. (Be aware, the population analyzed here is the Clinical Activity Evaluable Population and not the Full Analysis Set as used in outcome measure 1).

   Time frame: Up to 38.8 months

3. Progression Free Survival (PFS)

   PFS was defined as the time from the first dose of study drug to the date of PD or death due to any cause in the absence of documented PD, whichever occurs first.

   Time frame: Up to 40.6 months

4. Overall Survival (OS)

   OS was defined as the time from first dose of study drug to the date of death due to any cause.

   Time frame: Up to 43.8 months

5. Blood Plasma Concentrations

   Predose (trough) concentrations for sitravatinib

   Time frame: Cycle 1 Day 1 through Cycle 5 Day 1

Baseline characteristics

Study documents

• Study protocol · Feb 11, 2020
• Statistical analysis plan · Jan 10, 2022
• Informed consent form · Oct 25, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No