CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 319 enrolled
Drug / intervention
PDR001biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02404441
NCT02404441Phase 2Completed
CompareCT.gov

Open Label Multicenter Phase I/II Study of the Safety and Efficacy of PDR001 Administered to Patients With Advanced Malignancies

Novartis Pharmaceuticals·interventional·Posted Mar 31, 2015·Updated Aug 3, 2022

In Brief

A Phase 2 clinical trial evaluating PDR001 for Melanoma and 4 related conditions. Completed, enrolled 319 participants across 41 sites in 14 countries.

Detailed Summary

The purpose of this "first-in-human" study of PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent to adult patients with solid tumors. By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, PDR001 inhibits the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma, Non-small Sell Lung Cancer (NSCLC), Triple Negative Breast Cancer, Anaplastic Thyroid Cancer, Other Solid Tumors
CountriesCanada, France, Germany, Hungary, Italy, Lebanon, Netherlands, Norway, Poland, Spain, Taiwan, Thailand, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 31, 2015
Enrollment StartApr 27, 2015
Primary CompletionJul 21, 2020
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 11.3 years ago

Interventions

PDR001biological

anti-PD1 antibody