Trials Sponsors Conditions Drugs Pricing

Conditions

Recurrent/Metastatic Gastric Cancer

Outcome Measures

Primary Outcomes (2)

Phase 1b: Dose-limiting toxicity in subjects with M7824 and paclitaxel combination treatment
Within first 4 weeks
Phase 2: Progression-free survival in subjects with M7824 and paclitaxel combination treatment
At 24 weeks

Secondary Outcomes (6)

Overall survival
3 months after the last dose study treatment of the last subject
Objective response rate according to RECIST 1.1
3 months after the last dose study treatment of the last subject
Disease control rate according to RECIST 1.1
3 months after the last dose study treatment of the last subject
Duration of response according to RECIST 1.1
3 months after the last dose study treatment of the last subject
Progression-free survival according to RECIST 1.1
3 months after the last dose study treatment of the last subject
+1 more secondary outcomes

Study Arms (1)

Study treatment

EXPERIMENTAL

Drug: M7824+paclitaxel

Interventions

M7824+paclitaxelDrug

M7824 will be administered intravenously at a dose of 1200 mg every 3 weeks in combination with paclitaxel 80 (or 70) mg/m2 once a week for 3 weeks (each cycle is 4 weeks)

Study treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
Eligible male and female subjects aged ≥19 years.

Sponsors & Collaborators

Yonsei University
Otherlead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

Sun Young RHA, MD, PhD
Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine
PRINCIPAL INVESTIGATOR

Enrollment

49 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 8, 2021

Study Start

June 2, 2021

Actual (reported)

Primary Completion

Study of M7824 and Paclitaxel Combination as a Second-line Treatment in Patients With Recurrent/Metastatic Gastric Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

Study treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

Study treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations