NCT03606174|TerminatedPhase 2ResultsFDA Drug

Study Stopped

The study was terminated due to sponsor decision / portfolio prioritization, and not due to safety reasons.

A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma

Mirati Therapeutics Inc.ClinicalTrials.gov

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1 other identifier

516-003

Study Type

interventional

Target

260

Locations

1 country

Sites

Timeline

RegisteredJul 2018

StartedSep 2018

CompletionAug 2022

Brief Summary

The study will evaluate the clinical activity of PD-(L)1 Checkpoint Inhibitor regimens in combination with the investigational agent sitravatinib in patients with advanced or metastatic urothelial carcinoma.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

260

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Sep 2018

Typical duration for phase_2

Geographic Reach

1 country

36 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.9 years study duration

First Submitted

Initial submission to the registry

July 20, 2018

Completed

10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed

1 month until next milestone

Study Start

First participant enrolled

September 11, 2018

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2022

Completed

19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed

1 year until next milestone

Results Posted

Study results publicly available

August 24, 2023

Completed

Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

3.9 years

First QC Date

July 20, 2018

Results QC Date

August 3, 2023

Last Update Submit

August 3, 2023

Conditions

Urothelial Carcinoma Urothelial Carcinoma Bladder Urothelial Carcinoma Ureter Urothelial Carcinoma of the Renal Pelvis and Ureter Urothelial Carcinoma Urethra

Keywords

MGCD516Antineoplastic AgentsImmunologic FactorsNivolumabTyrosine Kinase InhibitorVEGFRTAM RTKsPD-1PD-L1PembrolizumabEnfortumab vedotinCheckpoint InhibitorsAntibody Drug ConjugatesADC

Outcome Measures

Primary Outcomes (1)

Objective Response Rate (ORR)
ORR was defined as the number of participants documented to have a confirmed investigator-assessed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). PR was defined as a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Up to approximately 3 years

Secondary Outcomes (10)

Number of Participants Who Experienced an Adverse Event (AE)
Day 1 up to approximately 3 years
Number of Participants Who Experienced a Serious Adverse Event (SAE)
Day 1 up to approximately 3 years
Number of Participants Who Experienced a Treatment-related Adverse Event
Day 1 up to approximately 3 years
Duration of Response (DOR)
Up to approximately 3 years
Clinical Benefit Rate (CBR)
Up to approximately 3 years
+5 more secondary outcomes

Study Arms (9)

Cohort 1

EXPERIMENTAL

Patients previously treated with checkpoint inhibitor and platinum-based chemotherapy. Nivolumab over 30 min IV infusion (240 mg IV every 2 weeks or 480 mg every 4 weeks) and sitravatinib 120 mg orally once per day continuously in 28-day cycles.