NCT03966118

Avelumab + Paclitaxel/ Ramucirumab (RAP) as Second Line Treatment in Gastro-esophageal Adenocarcinoma

Avelumab + Paclitaxel/ Ramucirumab as Second Line Treatment in Gastro-esophageal Adenocarcinoma: a Phase II Trial of the AIO (The RAP-Trial)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: P. C. Thuss-Patience · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Avelumab + Paclitaxel/ Ramucirumab as second line treatment in gastro-esophageal adenocarcinoma following first-line therapy with platinum and fluoropyrimidine doublet with or without anthracycline, docetaxel or trastuzumab

Detailed description

Patients with adenocarcinoma of the gastro-esophageal junction or the stomach who have documented progression after being treated with a 1st line chemotherapy which contained at least a platinum and 5-FU (5-Flourouracil)can be included. All patients will receive a standard second line therapy with paclitaxel and ramucirumab plus the investigational drug avelumab, a checkpoint inhibitor. Clinical and radiographic assessment will be performed regularly. Patients will be treated until disease progression, untolerable toxicity or withdrawal of consent.

Conditions

• Gastroesophageal Junction Adenocarcinoma
• Adenocarcinoma of the Stomach

Interventions

Type	Name	Description
DRUG	Avelumab	Avelumab 1mg/kg Day 1 and Day 15 of a 28-day cycle
DRUG	Ramucirumab	Ramucirumab 8mg/kg on Day 1 and Day 15 of a 28-day cycle
DRUG	Paclitaxel	Paclitaxel 80mg/m2 on Day 1, Day 8 and Day 15 of a 28-day cycle

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-09-01
• Completion: 2023-09-01
• First posted: 2019-05-29
• Last updated: 2019-06-03

Locations

1 site across 1 country: Germany