Trials / Recruiting
RecruitingNCT04150640
Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma
Phase 2 Trial of 5-Fluorouracil, Oxaliplatin and Liposomal Irinotecan and Immunotherapy (Plus Trastuzumab for HER2-positive Disease) During 1st Line Treatment of Advanced Esophageal and Gastric Adenocarcinoma
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will be better tolerated than current first-line chemotherapy combinations for this disease.
Detailed description
This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). Participants will be enrolled into one of four cohorts. Participants in Cohort 1 (HER-2 negative) will receive 5-FU, oxaliplatin and nal-IRI. Cohort 3 (HER-2 negative) will use nivolumab in addition to 5-FU, oxaliplatin and nal-IRI. Participants in Cohort 2 (HER-2 positive) will receive trastuzumab in addition to 5-FU, oxaliplatin and nal-IRI. Cohort 4 (HER-2 positive) will also include pembrolizumab in addition to trastuzumab, 5-FU, oxaliplatin and nal-IRI. Chemotherapy doses will be the same for all cohorts and will follow similar modifications for toxicities. Agents will be administered as per institutional standards when similar regimens (such as FOLFIRINOX, FOLFOX, and trastuzumab) are used. Cohort 1 (HER2-negative tumors): Up to 13 evaluable participants will be accrued to Cohort 1. Cohort 2 (HER2-positive tumors): Up to a total of 6 subjects will be enrolled to evaluate the safety and tolerability of the proposed 5-Fluorouracil, Oxaliplatin and liposomal Irinotecan combination in HER2-positive subjects. Cohort 3 (HER-2 negative tumors):12 participants will be enrolled during stage 1. If at most 5 objective responses per RECIST 1.1 are observed, then further enrollment will be halted. Otherwise, 15 additional participants will be enrolled for a total number of 27. Cohort 4 (HER-2 positive tumors): treated with oxaliplatin, Nal-IRI and trastuzumab in combination with pembrolizumab. A total of up to 6 subjects will be accrued to evaluate safety and tolerability.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nal-IRI | chemotherapy drug |
| DRUG | Oxaliplatin | chemotherapy drug |
| DRUG | 5-FU | chemotherapy drug |
| DRUG | Trastuzumab | immunotherapy |
| DRUG | Pembrolizumab | immunotherapy |
| DRUG | Nivolumab | immunotherapy |
Timeline
- Start date
- 2020-07-13
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2019-11-05
- Last updated
- 2026-02-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04150640. Inclusion in this directory is not an endorsement.