Actively Recruiting
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
Led by Harry H Yoon · Updated on 2025-07-31
58
Participants Needed
2
Research Sites
314 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
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.
CONDITIONS
Official Title
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization before registration
- Be 18 years or older at consent
- Have ECOG Performance Status of 0-1 within 28 days prior to registration
- Provide tumor tissue from biopsy before registration or before first treatment day
- Willing to give tissue and blood samples for research and have a biopsy-accessible tumor lesion
- PD-L1 test results available or obtained before first treatment
- Confirmed adenocarcinoma of stomach or gastroesophageal junction
- Disease must be metastatic, recurrent, or locally advanced and unresectable
- Eligible for pembrolizumab, ramucirumab, and paclitaxel (or nab-paclitaxel)
- Adequate organ function as defined by specified blood counts and liver/kidney function tests
- Females of childbearing potential must have negative pregnancy test before registration
- Both females of childbearing potential and males must use effective contraception until 120 days after treatment ends
- Willing to return for follow-up visits
- Cohort-specific: measurable disease per RECIST v1.1 for Cohort 1
- Cohort-specific: measurable or evaluable disease per RECIST v1.1 for Cohort 2
- Cohort-specific: prior anti-PD-1 therapy for Cohort 2
- Cohort-specific: PD-L1 combined positive score or tumor proportion score of 1 or higher for Cohort 2
You will not qualify if you...
- History of interstitial lung disease or drug-induced lung disease requiring steroids
- Certain heart conditions including serious arrhythmias or recent arterial thromboembolic events
- Uncontrolled high blood pressure despite treatment
- Recent serious gastrointestinal bleeding
- Severe liver cirrhosis or related complications
- Recent hemoptysis or tumor invasion of major blood vessels posing high risk
- Recent gastrointestinal perforation or fistula
- Serious or nonhealing wounds or fractures within 28 days
- Major surgery within 28 days before treatment or planned during trial
- Serious concurrent illnesses affecting safety or study assessment
- Active autoimmune disease needing systemic treatment in last 6 months
- Participation in another investigational study within 4 weeks
- Prior combined anti-angiogenesis and cytotoxic chemotherapy
- Known HIV infection or active hepatitis B or C
- Severe allergic reactions to monoclonal antibodies or pembrolizumab
- Recent monoclonal antibody cancer treatment without full recovery
- Active other cancers requiring treatment
- Active, unstable brain metastases or carcinomatous meningitis
- Uncontrolled intercurrent illnesses including severe heart failure, angina, lung disease, active tuberculosis, uncontrolled diabetes, liver disease, or psychiatric disorders
- Active infections requiring systemic therapy
- Conditions or treatments interfering with trial participation or safety
- Pregnancy, breastfeeding, or planning pregnancy
- Active non-infectious pneumonitis
- Uncontrolled thyroid or adrenal disorders posing risk
- Recent live vaccine use within 30 days
- Prior serious immune checkpoint inhibitor toxicity
- Severe pre-existing nerve damage
- Prior organ or allogeneic transplant
- Cohort-specific exclusions including disease progression or intolerance to prior PD-1/PD-L1 therapies and weight loss during prior therapy for Cohort 1
AI-Screening
AI-Powered Screening
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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
CONTACT
A
Ahran Lee
CONTACT
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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