Trials / Unknown
UnknownNCT03785496
Study to Evaluate Efficacy of PDR001 in Patients With Squamous Cell Carcinoma of the Esophagus
Phase II Study to Evaluate Efficacy of PDR001 in Patients With Squamous Cell Carcinoma of the Esophagus
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Yonsei University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Single arm phase II PDR001( 300mg, IV) will be treated every 3 weeks
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PDR001 | PDR001 will be administered once every 3 weeks via i.v. infusions over 30 minutes, respectively. Infusions of each antibody can be extended to up to 2 hours if clinically indicated. A scheduled dose of ongoing study drugs may be delayed by up to 7 days to recover from previous AEs or a missed visit. If a scheduled dose of ongoing study drugs is delayed longer than 7 days due to an unresolved AE, the administration should be skipped and treatment resumed at the next scheduled dose. The assessment schedule will be shifted accordingly. |
Timeline
- Start date
- 2020-02-18
- Primary completion
- 2022-01-01
- Completion
- 2024-01-01
- First posted
- 2018-12-24
- Last updated
- 2021-05-06
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03785496. Inclusion in this directory is not an endorsement.