Vactosertib in Combination with Pembrolizumab for PD-L1 P... | NCT04515979

Studies
Vactosertib in Combination with Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) Subjects

NCT04515979

Sponsor

MedPacto, Inc.

Status

Terminated

Last Update Posted

Dec 9, 2024Actual

Enrollment

11Actual

Phase

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vactosertib 300 mg BID and pembrolizumab 200 mg IV

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MK3475 B37	Other Identifier	Merck

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This is because Medpacto decided to modify its development strategy as the business and development environment changed.

Expanded Access Info

Start Date

Dec 17, 2020Actual

Primary Completion Date

Aug 5, 2024Actual

Completion Date

Aug 5, 2024Actual

First Submitted Date

Aug 11, 2020

First Submission Date that Met QC Criteria

Aug 13, 2020

First Posted Date

Aug 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2024

Last Update Posted Date

Dec 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is Phase 2, open label, multi-center study to assess safety and efficacy of vactosertib in combination with pembrolizumab as 1st line treatment for subjects with advanced or metastatic, PD-L1 positive, non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and in whom EGFR, ALK, BRAF, ROS1-directed therapy is not indicated.

Detailed Description

Approximately 55 NSCLC subjects with PD-L1 tumor proportion score (TPS) ≥ 1% are expected to be enrolled in this study. Subjects' TPS will be determined by PD-L1 IHC 22C3 pharmDx assay performed according to local laboratory regulations prior to study enrollment.

Subjects who received adjuvant or neoadjuvant therapy are permitted onto the study if the therapy was completed at least 12 months prior to the development of metastatic disease.

Eligible subjects will receive:

• Vactosertib 300 mg orally (PO) BID for 5 days with 2 days off period (5 days on/2days off) and pembrolizumab 200 mg IV on Day 1 of every 3-week cycle (Q3W).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vactosertib+Pembrolizumab	Experimental	Vactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks	Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vactosertib 300 mg BID and pembrolizumab 200 mg IV	Drug	Vactosertib 300 mg orally (PO) BID(5 days on/2days off) and pembrolizumab 200 mg IV (Q3W).	vactosertib+Pembrolizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ORR per RECIST 1.1	ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a histologically- or cytologically-documented NSCLC advanced or stage IV lung cancer
Have confirmation that EGFR, ALK, BRAF, ROS1-directed therapy is not indicated
Have measurable disease based on RECIST 1.1
PD-L1 expression is ≥1% as determined by the PD-L1 IHC 22C3 pharmDx assay
Have a life expectancy of at least 3 months.
ECOG 0 or 1
Subjects must be able to swallow tablets and absorb vactosertib.
Have adequate organ function as indicated by the following laboratory values in

Exclusion Criteria:

Is currently participating in a study of an investigational agent
Has received prior systemic cytotoxic chemotherapy for metastatic disease/ antineoplastic biological therapy /Had major surgery / radiation therapy to the lung
Has received a live vaccine within 30 days prior to the first dose of study drug.
Is taking prohibited medications
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Had a severe hypersensitivity reaction to treatment with another mAb previously.
Has severe hypersensitivity to vactosertib and/or any of its excipients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Minkyu Heo	MedPacto, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		06351	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
C000590371	vactosertib
C494814	BID protein, human
C582435	pembrolizumab