OncoMatch/Clinical Trials/NCT04069273
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
Is NCT04069273 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab Monotherapy and Ramucirumab for gastric cancer.
Treatment: Pembrolizumab Monotherapy · Ramucirumab · Paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
PD-L1 results are required, if available. If PD-L1 testing has not been done, it should be ordered as standard of care prior to C1D1. PD-L1 testing must be performed by a CLIA certified lab using the Dako 22C3 antibody.
Required: PD-L1 (CD274) (CPS ≥ 1 or TPS ≥ 1)
PD-L1 combined positive score (CPS) ≥ 1 or tumor proportion score (TPS) ≥ 1 at any time before registration.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — preceding therapy (Cohort 2)
Received anti-PD-1 therapy with or without concurrent cytotoxic chemotherapy as preceding therapy.
Cannot have received: anti-angiogenesis agent with cytotoxic agent(s)
Exception: Prior single-agent anti-angiogenesis therapy (eg, ramucirumab monotherapy) is allowed.
Prior therapy combining anti-angiogenesis agent with cytotoxic agent(s).
Cannot have received: anti-cancer monoclonal antibody (mAb), excluding anti-PD-1/-L1 therapy
Has had a prior anti-cancer monoclonal antibody (mAb), excluding anti-PD-1/-L1 therapy, within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 3 weeks earlier.
Lab requirements
Blood counts
ANC ≥ 1,100/mm3; Hemoglobin ≥ 8.5 g/dL without transfusion or EPO dependency; Platelets ≥ 100,000 / mcL
Kidney function
Creatinine ≤ 1.5 x ULN OR CrCl ≥ 60 mL/min for subject with creatinine levels > 1.5 x institutional ULN
Liver function
Total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN OR total bilirubin ≤ 2 x ULN if liver metastases are present (patients with Gilbert's syndrome are allowed); AST and ALT ≤ 2.5 X ULN OR ≤ 5 x ULN for subjects with liver metastases; Albumin > 3.0 g/dL
Cardiac function
No clinically important abnormalities in rhythm, conduction or morphology of resting ECG; no symptomatic heart failure; no uncontrolled hypokalemia despite repletion; no congenital long QT syndrome; no family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives; no arterial thromboembolic events within 6 months prior to first dose; no uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) despite standard medical management.
Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 28 days prior to registration. NOTE: Labs must also be obtained within 10 days prior to C1D1 treatment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic- Minnesota · Rochester, Minnesota
- Froedtert and The Medical College of Wisconsin · Milwaukee, Wisconsin
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify