NCT04069273 · Harry H Yoon
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
(SEQUEL)
What this study is about
group of participants 1 \[CLOSED\] Study treatment involves two segments: (1) Induction Immunotherapy segment with pembrolizumab treatment given alone every 3 weeks until irRECIST PD and (2) two or more treatments used together segment. Nab-paclitaxel may be utilized in place of paclitaxel at investigator's discretion for subjects with paclitaxel reactions.
View original scientific description
Cohort 1 \[CLOSED\] Study treatment involves two segments: (1) Induction Immunotherapy segment with pembrolizumab monotherapy every 3 weeks until irRECIST PD and (2) Combination Therapy segment. Nab-paclitaxel may be utilized in place of paclitaxel at investigator's discretion for subjects with paclitaxel reactions. Cohort 2 Patients are randomized to Arm A or B. Treatment in both arms includes pembrolizumab + RAM + paclitaxel.
Interventions
DRUG
Pembrolizumab Monotherapy
Pembrolizumab 200 mg IV
DRUG
Ramucirumab
Ramucirumab 10 mg/kg IV
DRUG
Paclitaxel
Paclitaxel 90 mg/m2 IV
Primary outcome measures
Cohort 1: Evaluate the best overall response rate (BORR) by pooling Arm A and Arm B
Time frame: 3 years
BORR is defined as the number of best responses (including rates of complete response \[CR\], partial response \[PR\], disease control \[DCR\], stable disease \[SD\], progressive disease \[PD\]) divided by the total number of evaluable patients. Evaluate the BORR of combined ramucirumab (RAM) plus paclitaxel (with differing schedules of pembrolizumab \[PEM\]) following induction of PEM in patients with advanced gastric and GEJ adenocarcinoma pooling Arm A and B.
Cohort 2: Evaluate Progression free survival (PFS) of Ramucirumab (RAM) plus Paclitaxel plus Pembrolizumab (PEM)
Time frame: 3 years
PFS is defined as the time from the date of randomization to the first documented disease progression or death due to all causes, whichever occurs first. Evaluate PFS of combined ramucirumab (RAM) plus paclitaxel plus pembrolizumab (PEM) in patients with advanced gastric and GEJ adenocarcinoma with prior exposure to immunotherapy, within Arm A and Arm B separately.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status (PS) of 0-1within 28 days prior to registration. NOTE: Within 0-3 days prior to the anticipated C1D1, ECOG PS must be 0-1.
- Tumor tissue must be obtained from a biopsy performed either (a) prior to registration or (b) prior to C1D1, as described below.
- Prior to registration: if a biopsy was performed prior to registration and no interval systemic anti-cancer treatment was administered between the biopsy collection and C1D1, part of that tissue is required for correlative analysis, and must be identified during screening and shipped after registration. In this situation, tissue from a new biopsy is not required.
- Prior to C1D1: For all other subjects, a new biopsy prior to C1D1 is require
Where
- Rochester, Minnesota
- Milwaukee, Wisconsin
Collaborators
Merck Sharp & Dohme LLC, Mayo Clinic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2025 · Source of record for eligibility and locations