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Anti-microtubule agent
Immunotherapy + Anti-angiogenesis + Chemotherapy for Gastroesophageal Cancer (SEQUEL Trial)
Phase 2
Recruiting
Led By Harry H Yoon, MD, MHS
Research Sponsored by Harry H Yoon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically proven adenocarcinoma of the stomach or GEJ
Metastatic, recurrent, or locally advanced unresectable disease
Must not have
Disease progression according to RECIST v1.1 or irRECIST, or treatment intolerance, during prior therapy with an anti-PD-1, anti-PD-L1, or anti- PD-L2 agent
Pre-existing motor or sensory neurotoxicity grade 3 or higher
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Summary
This trial uses a combination of drugs to treat cancer patients who may not respond to standard treatments. The drugs help the immune system fight cancer, block blood supply to tumors, and stop cancer cells from dividing.
Who is the study for?
Adults with advanced stomach or gastroesophageal cancer, good organ function, and an ECOG Performance Status of 0-1. They must provide tissue samples, have measurable disease per RECIST v1.1, not be pregnant or breastfeeding, use effective contraception if of childbearing potential, and agree to follow-up visits.
What is being tested?
The trial tests Pembrolizumab alone followed by combination therapy with Ramucirumab and Paclitaxel for advanced stomach cancers. Patients are randomly assigned to two groups receiving these treatments to compare effectiveness.
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used; fatigue; blood disorders; issues affecting organs like the liver or lungs; gastrointestinal complications such as bleeding or perforation; and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of stomach or GEJ cancer confirmed by lab tests.
Select...
My cancer has spread, come back, or can't be removed with surgery.
Select...
I agree to give tissue and blood samples for research and have a cancer that can be biopsied again.
Select...
I cannot provide a tissue sample for medical reasons.
Select...
I am 18 years old or older.
Select...
I have had a biopsy to confirm my cancer before joining the trial or starting treatment.
Select...
I have been mostly active and able to carry on all pre-disease activities without restriction in the last 28 days.
Select...
I am 18 years old or older.
Select...
I am eligible for treatment with pembrolizumab, ramucirumab, and paclitaxel.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer got worse or I couldn't tolerate the treatment with specific immune therapy.
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I do not have severe nerve damage.
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I have had a heart attack or stroke in the last 6 months.
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I have had a solid organ or bone marrow transplant.
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I lost 5% or more of my weight while on anti-PD-1/L1/L2 therapy.
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My heart health meets the study's requirements.
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My liver condition is severe, with significant symptoms like confusion or fluid in the abdomen.
Select...
I haven't had serious wounds, ulcers, or fractures in the last 28 days.
Select...
I have had a GI perforation or am at risk for one in the last 6 months.
Select...
I have not coughed up blood or have a tumor invading major blood vessels.
Select...
I have had severe GI bleeding in the last 3 months.
Select...
I have an autoimmune disease treated with medication in the last 2 years.
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I have had lung conditions that needed steroid treatment.
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I haven't had any cancer treatment with monoclonal antibodies in the last 3 weeks or have recovered from their side effects.
Select...
I have a history of lung inflammation not caused by an infection.
Select...
I am currently being treated for an infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cohort 1: Evaluate the best overall response rate (BORR) by pooling Arm A and Arm B
Cohort 2: Evaluate Progression free survival (PFS) of Ramucirumab (RAM) plus Paclitaxel plus Pembrolizumab (PEM)
Secondary study objectives
Assess the frequency and severity of adverse events
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment3 Interventions
Pembrolizumab will be administered every 3 weeks in combination with ramucirumab + paclitaxel. The paclitaxel schedule differs between the 2 arms.
Group II: Arm AExperimental Treatment3 Interventions
Pembrolizumab will be administered every 3 weeks in combination with ramucirumab + paclitaxel. The paclitaxel schedule differs between the 2 arms.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
2017
Completed Phase 3
~5050
Paclitaxel
2011
Completed Phase 4
~5810
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for gastroesophageal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while targeted therapies like trastuzumab and ramucirumab focus on specific molecular targets such as HER2 and VEGFR2, respectively, to inhibit tumor growth.
Immunotherapy, particularly PD-1 inhibitors like pembrolizumab, works by blocking the PD-1 pathway, which cancer cells exploit to evade the immune system. By inhibiting this pathway, pembrolizumab enhances the body's immune response against cancer cells.
This is particularly important for gastroesophageal cancer patients as it offers a treatment option that can potentially improve survival rates and quality of life, especially in cases where traditional therapies are less effective.
Esophageal and Esophagogastric Junction Cancers, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology.
Esophageal and Esophagogastric Junction Cancers, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology.
Find a Location
Who is running the clinical trial?
Mayo ClinicOTHER
3,312 Previous Clinical Trials
2,954,532 Total Patients Enrolled
Harry H YoonLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,975 Previous Clinical Trials
5,177,823 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer got worse or I couldn't tolerate the treatment with specific immune therapy.You are currently taking part in another study involving medication or have done so in the past 4 weeks.I do not have severe nerve damage.I am a woman who can have children and have a negative pregnancy test taken within the last 3 days.My cancer is a type of stomach or GEJ cancer confirmed by lab tests.My cancer has spread, come back, or can't be removed with surgery.I have had a biopsy to confirm my cancer before joining the trial or starting treatment.I have had a heart attack or stroke in the last 6 months.I lost 5% or more of my weight while on anti-PD-1/L1/L2 therapy.You have given written permission to share your personal health information and agreed to participate in the study.You must participate in a separate biopsy study to collect tissue samples for research purposes.I agree to give tissue and blood samples for research and have a cancer that can be biopsied again.My organs are functioning well.I had pancreatitis that needed treatment within the last 6 months.I have had a solid organ or bone marrow transplant.My heart health meets the study's requirements.My liver condition is severe, with significant symptoms like confusion or fluid in the abdomen.I am willing to go back to the hospital where I enrolled for check-ups.I haven't had serious wounds, ulcers, or fractures in the last 28 days.I have had a GI perforation or am at risk for one in the last 6 months.My brain metastases are stable, and I haven't used steroids in the last 7 days.I have not had major surgery in the last 28 days.I had severe gut inflammation needing treatment within the last 6 months.I have not coughed up blood or have a tumor invading major blood vessels.I do not have another cancer that needs treatment and could affect this study.I have been treated with a combination of drugs that stop tumor blood vessel growth and chemotherapy.My cancer hasn't worsened in the last 2 weeks after palliative radiation therapy.I need to have a new biopsy before starting the trial.My cancer has been or will be tested for PD-L1 using a specific method.You have a mental health or substance abuse issue that could make it difficult for you to follow the trial requirements.I have had severe GI bleeding in the last 3 months.I cannot provide a tissue sample for medical reasons.I have been mostly active and able to carry out all my pre-disease activities recently.My thyroid or adrenal gland disorder is not well-controlled and may pose a high risk with the study treatment.I have an autoimmune disease treated with medication in the last 2 years.I agree to give tissue and blood samples and have a tumor that can be biopsied again.I have had lung conditions that needed steroid treatment.I provided a tissue sample for analysis before starting the trial, with no cancer treatment in between.I haven't had any cancer treatment with monoclonal antibodies in the last 3 weeks or have recovered from their side effects.I have not received a live vaccine in the last 30 days.I have a history of lung inflammation not caused by an infection.I am 18 years old or older.I have had a biopsy to confirm my cancer before joining the trial or starting treatment.I have not taken any corticosteroids in the last two weeks.I have been mostly active and able to carry on all pre-disease activities without restriction in the last 28 days.I am 18 years old or older.I am eligible for treatment with pembrolizumab, ramucirumab, and paclitaxel.My high blood pressure has not been controlled with medication for over 4 weeks.I am currently being treated for an infection.I do not have any severe illnesses that would make the study treatment too risky for me.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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