Phase 2
N=18
Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas
Gastric Adenocarcinoma · Esophageal Adenocarcinoma · Metastasis · HER-2 Gene Amplification
Bottom Line
View on ClinicalTrials.gov: NCT03783936 ↗Enrolled (actual)
18
Serious AEs
38.9%
Results posted
Dec 2023
Primary outcome: Primary: Best Objective Response Rate (bORR) — 61; 50 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxaliplatin (Drug); Leucovorin (Drug); 5 fluorouracil (Drug); Trastuzumab (Drug); Avelumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ashwin Somasundaram
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Objective Response Rate (bORR) |
61; 50 | — |
| SECONDARY Progression Free Survival (PFS) |
8 | — |
| SECONDARY Progression Free Survival by iRECIST(iPFS) |
8 | — |
| SECONDARY Overall Survival (OS) |
13.1 | — |
| SECONDARY Disease Control Rate (DCR) |
55.6 | — |
| SECONDARY Number of Participants With Grade 3-4 Treatment Related Adverse Events |
6; 2; 2; 1; 1; 2 | — |
Summary
The initial intent of the study was to be a multi-center single-arm open-label Simon's two-stage Phase II clinical trial of first-line mFOLFOX6 + trastuzumab + avelumab in metastatic HER2-amplified gastric and esophageal adenocarcinomas.
Accrual will halt after completion of Stage I (enrollment of 18 patients). This decision is not due to safety issues. Subjects currently on treatment will continue until criteria as defined in the protocol is met.
Eligibility Criteria
Inclusion Criteria
- Written informed consent and HIPAA authorization for release of personal health information prior to registration.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0 or 1.
- Histologically confirmed esophageal, gastroesophageal junction, or gastric adenocarcinoma, with unresectable or metastatic disease documented on diagnostic imaging studies.
- HER2 amplification confirmed by standard of care testing of tumor specimen (3+ by immunohistochemistry, or 2+ on IHC with ISH with HER2/CEP17 ratio ≥2).
- Radiographically measurable disease according to RECIST 1.1 within 28 days prior to registration.
- Adequate organ function as defined in the table below. All screening labs to be obtained within 28 days prior to registration.
- Absolute Neutrophil Count ≥ 1.5 x 10^9/L
- Hemoglobin (Hgb) ≥ 9 g/dL (may have been transfused)
- Platelets ≥ 100 x 10^9/L OR ≥ 75 x 10^9/L for patients who received Cycle 1 of mFOLFOX6 +/- trastuzumab prior to registration
- Calculated creatinine clearance1 ≥ 30 mL/min OR creatinine ≤ 1.5 × upper limit of normal (ULN)
- Bilirubin ≤ 1.5 × upper limit of normal (ULN) (Subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level >1.5 mg/dL, if their conjugated bilirubin is 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
- Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with informed consent, the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Data sourced from ClinicalTrials.gov (NCT03783936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.