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Combination Therapies for Esophageal Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has histologically and/or cytologically confirmed diagnosis of previously treated, 2L (received first line (1L) treatment) gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma

Has metastatic disease or locally advanced, unresectable disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~52 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different combinations of drugs to see which one is safer and more effective for treating advanced stomach, esophageal, or gastroesophageal junction cancer in participants who have not responded

Who is the study for?

This trial is for people with advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma who've had one prior treatment fail. They must have a life expectancy of at least 3 months and be in good physical condition (able to perform daily activities without significant limitations). Participants need to provide a tumor tissue sample and should not have HER2/neu positive cancer.

What is being tested?

The study compares the safety and effectiveness of MK-2870 combined with paclitaxel versus Ramucirumab with paclitaxel in patients whose first line of therapy didn't work. It's an open-label trial meaning everyone knows which treatment they're getting, but it won't test formal hypotheses.

What are the potential side effects?

Possible side effects include those commonly associated with chemotherapy such as fatigue, nausea, hair loss (alopecia), changes in blood counts leading to increased infection risk or bleeding problems. Side effects from MK-2870 are currently under investigation since it's a newer drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been previously treated for stomach, GEJ, or esophageal cancer.

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My cancer has spread or cannot be removed by surgery.

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My cancer progressed after first-line treatment including platinum.

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My cancer is not HER2 positive.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~52 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~52 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~52 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Percentage of Particiapants who Experience an Adverse Event (AE) During the Safety Lead-In Phase

Percentage of Participants who Discontinue Study Intervention Due to an AE During the Safety Lead-In Phase

+1 more

Secondary study objectives

Duration of Response (DOR)

Incidence of MK-2870 anti-drug antibody (ADA)

Overall Survival (OS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MK-2870 + PaclitaxelExperimental Treatment2 Interventions

Following a 28-day run-in with MK-2870 at 3 mg/kg and 4 mg/kg IV infusion on Days 1 and 15 of a 6-week cycle plus paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8 and 15 of a 4-week cycle, participants will receive paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8, 15 of each 4-week cycle (3 weeks on and 1 week off) up to \~60 weeks plus MK-2870 at selected dose IV infusion on days 1, 15, 29 of every 6-week cycle until discontinuation.

Group II: Ramucirumab + PaclitaxelActive Control2 Interventions

Participants will receive ramucirumab at 8mg/kg via intravenous (IV) infusion on days 1 and 15 of each 4-week cycle for up to \~60 weeks plus paclitaxel at 80 mg/M\^2 via IV infusion on Days 1, 8, and 15 of each 4-week cycle (3 weeks on and 1 week off) for up to \~60 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

0 / 5Eligibility criteria met