Actively Recruiting
Phase 2 Study of Pembrolizumab With Ramucirumab and Paclitaxel in Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
Led by Harry H Yoon · Updated on 2025-07-31
58
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
H
Harry H Yoon
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new immunotherapy approach combined with anti-angiogenesis and chemotherapy for adults with advanced gastric and gastroesophageal junction adenocarcinoma. This Phase 2 study aims to assess how well these treatments work together by comparing different treatment schedules in patients with advanced cancer of the stomach or related areas who have specific tumor characteristics and are eligible for these therapies. The study includes two parts: an initial immunotherapy segment using pembrolizumab alone every three weeks until disease progression, followed by a combination therapy segment where patients receive pembrolizumab together with ramucirumab and paclitaxel. Patients in the second cohort are randomly assigned to one of two treatment arms that differ in the schedule of paclitaxel administration. Nab-paclitaxel may be used instead of paclitaxel if patients have reactions to paclitaxel. Participants will undergo tumor biopsies before starting treatment and provide tissue and blood samples during the study. Researchers will monitor tumor response rates and progression-free survival over three years. Patients will have regular assessments including blood tests, imaging, and safety monitoring to evaluate adverse events. The study requires follow-up visits and ongoing evaluation to understand how the treatments affect the cancer and patient health over time.
CONDITIONS
Brief Title
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization before registration.
- Age 18 years or older at time of consent.
- ECOG Performance Status of 0-1 within 28 days before registration and prior to first treatment.
- Tumor tissue available from biopsy before registration or before first treatment.
- Willingness to provide tissue and blood samples for research.
- PD-L1 test results available or ordered before first treatment.
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
- Metastatic, recurrent, or locally advanced unresectable disease.
- Candidate for pembrolizumab, ramucirumab, and paclitaxel (or nab-paclitaxel).
- Adequate organ function as defined by blood test criteria within 28 days before registration and 10 days before first treatment.
- Negative pregnancy test for females of childbearing potential within 72 hours before registration.
- Use of effective contraception for females of childbearing potential and males from consent until 120 days after treatment ends.
- Willingness to return for follow-up visits.
You will not qualify if you...
- History of interstitial lung disease or radiation pneumonitis requiring steroids.
- Certain serious heart conditions or abnormal ECG findings.
- Recent arterial thromboembolic events within 6 months.
- Uncontrolled or poorly controlled high blood pressure.
- Recent severe gastrointestinal bleeding within 3 months.
- Advanced cirrhosis or liver problems causing significant symptoms.
- Recent hemoptysis or blood vessel invasion by cancer posing high risk.
- History of gastrointestinal perforation or fistula within 6 months.
- Serious or nonhealing wounds or fractures within 28 days.
- Major surgery within 28 days before treatment or planned during study.
- Severe other illnesses that interfere with safety or assessment.
- Active autoimmune disease requiring recent systemic treatment.
- Participation in other investigational studies within 4 weeks before treatment.
- Prior therapy combining anti-angiogenesis with cytotoxic agents.
- Known HIV infection or active Hepatitis B or C.
- Severe allergic reactions to monoclonal antibodies or pembrolizumab.
- Recent treatment with other anticancer monoclonal antibodies.
- Other active cancers requiring treatment that affect evaluation.
- Active unstable brain metastases or carcinomatous meningitis.
- Uncontrolled illnesses posing high risk with study treatment.
- Active infections requiring systemic therapy before treatment.
- Conditions or therapies interfering with participation or safety.
- Pregnancy, breastfeeding, or planning to conceive during study.
- Active non-infectious pneumonitis posing high risk.
- Uncontrolled thyroid or adrenal disorders posing high risk.
- Recent live vaccine within 30 days before registration.
- Prior severe immune therapy toxicities within 6 months.
- Severe pre-existing nerve damage.
- Prior solid organ or allogeneic transplant.
- For Cohort 1: Measurable disease required, no prior progression on anti-PD-1/L1/L2 therapy.
- For Cohort 2: Measurable or evaluable disease, prior anti-PD-1 therapy, and PD-L1 expression required.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive pembrolizumab every 3 weeks in combination with ramucirumab and paclitaxel. The paclitaxel schedule differs depending on the assigned treatment arm.
Visits every 3 weeks for treatment administration
Duration - Up to 3 years
Participants are monitored for safety and treatment outcomes after the treatment period ends.
Periodic follow-up visits as scheduled by the study team
Trial Site Locations
Total: 2 locations
1
Mayo Clinic- Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
H
Harry H Yoon, MD, MHS
A
Ahran Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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