Carboplatin, Paclitaxel With or Without Avelumab in Advanced or Recurrent Endometrial Cancer
NCT03503786 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2023-11-13
Summary
This study aims to evaluate the safety and activity of the Avelumab in combination with Carboplatin-Paclitaxel in advanced or recurrent endometrial cancer
Conditions
Interventions
- DRUG
-
Carboplatin AUC 5 i.v. every 3 weeks for 6 - 8 cycles
- DRUG
-
Paclitaxel 175 mg/m2 i.v. every 3 weeks for 6-8 cycles
- DRUG
-
Avelumab
Avelumab 10 mg/kg every 3 weeks for 6-8 cycles + Avelumab 10 mg/kg every 14 days until disease progression or unacceptable toxicity
Sponsors & Collaborators
-
National Cancer Institute, Naples
lead OTHER
Principal Investigators
-
Sandro Pignata, M.D., Ph.D. · National Cancer Institute, Naples
-
Francesco Perrone, M.D., Ph.D. · National Cancer Institute, Naples
-
Gennaro Daniele, M.D., Ph.D. · National Cancer Institute, Naples
-
Ciro Gallo, M.D. · University of Campania Luigi Vanvitelli
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-01
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- Italy
Study Locations
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