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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
SEQUEL Trial Summary
This trial will study two new combinations of immunotherapy drugs to treat stomach and junction cancer. Pembrolizumab will be given to all patients in the trial.
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.Check my eligibility
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.See study design
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.
SEQUEL Trial 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.
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My cancer has spread, come back, or can't be removed with surgery.
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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.
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I am 18 years old or older.
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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.
SEQUEL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Assess the frequency and severity of adverse events
Cohort 1: Compare BORR between Arm A and Arm B.
Cohort 1: Compare progression free survival [PFS] between Arm A vs Arm B
+3 moreSEQUEL 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
~5380
Find a Location
Who is running the clinical trial?
Mayo ClinicOTHER
3,207 Previous Clinical Trials
3,767,082 Total Patients Enrolled
Harry H YoonLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,946 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Pembrolizumab Monotherapy?
"As the trial is in its early stages, Power assigned a score of 2 to Pembrolizumab Monotherapy's safety due to some evidence indicating that it is secure but no data indicating effectiveness."
Answered by AI
Could you speak to the efficacy of Pembrolizumab Monotherapy in other clinical studies?
"Currently, there are 1718 studies focused on Pembrolizumab Monotherapy with 326 of these trials in their final phase. While most research is carried out in Shanghai, China, a total of 75034 sites offer this particular intervention."
Answered by AI
Is the enrollment period still open for this research endeavor?
"Indeed, clinicaltrials.gov indicates that this investigation is actively searching for participants. This research was initially published on December 1st 2020 and has been updated most recently on September 12th 2022. 58 people need to be enrolled at the single trial site."
Answered by AI
What is the total enrollment for this research project?
"Affirmative. The data on clinicaltrials.gov indicates that this research is actively enrolling individuals. It was originally listed on December 1st 2020, and last edited September 12th 2022; 58 participants are being sought across a single site."
Answered by AI
What medical treatments does Pembrolizumab Monotherapy typically target?
"Unresectable melanoma can be effectively managed with Pembrolizumab Monotherapy. This treatment has also proven effective for microsatellite instability high, a propensity for recurrence, and other ailments."
Answered by AI
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