Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Immunoglobulins

Spartalizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

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.

PDR001

Byoung Chul Cho

Single arm phase II PDR001( 300mg, IV) will be treated every 3 weeks

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

In the first stage of the trial, 22 patients will be recruited, and their tumor response will be assessed RECIST criteria, which is widely used tumor assessment criteria in immuno-oncology agent trials. The best response until 6 months according to irRECIST will be evaluated, and this trial will proceed to second stage if three or more respondents (irPR or irCR) are observed among 22 patients. The response (PR or CR) should be confirmed by next disease assessment(6 weeks/2cycles after initial response).

Subjects who discontinue trial treatment for a reason other than recurrence will move into the Follow-Up Phase and should be assessed every 16 weeks (± 14 days) by radiologic imaging to monitor disease status.

PFS is defined as the time between the day of first cycle and the date of first documentation of progression or date of death, whichever occurs first. Documentation of progression will be defined as per RECIST criteria based on investigator assessment. Patients without documented progression or death will be censored at the date of last tumor assessment (or, if no tumor assessments are performed after the baseline visit).

OS is defined as the time between the day of first cycle and the date of death. Patients without documented death will be censored at the date of last contact.

DCR is defined as the percentage of patients with cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents. RECIST will be used in this study for assessment of tumor response. While either CT or MRI may be utilized, as per RECIST, CT is the preferred imaging technique in this study.

Yonsei University

Spots Global Cancer Trial Database for Study to Evaluate Efficacy of PDR001 in Patients With Squamous Cell Carcinoma of the Esophagus

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial