Trials / Completed
CompletedNCT02404441
Phase I/II Study of PDR001 in Patients With Advanced Malignancies
Open Label Multicenter Phase I/II Study of the Safety and Efficacy of PDR001 Administered to Patients With Advanced Malignancies
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 319 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study was designed as a phase I/II, multi-center, open-label study starting with a phase I dose escalation part followed by a phase II part. Although the study had 2 'arms', the phase I part of the study had 5 dosing cohorts and the phase ll part had 5 treatment groups for a total of 10 reporting groups. PDR001 was administered every 2 weeks until patient experienced unacceptable toxicity, progressive disease per immune related Response Criteria (irRC) and/or treatment was discontinued at the discretion of the investigator or the patient.
Conditions
- Melanoma
- Non-small Sell Lung Cancer (NSCLC)
- Triple Negative Breast Cancer
- Anaplastic Thyroid Cancer
- Other Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PDR001 | anti-PD1 antibody |
Timeline
- Start date
- 2015-04-27
- Primary completion
- 2020-07-21
- Completion
- 2020-07-21
- First posted
- 2015-03-31
- Last updated
- 2022-08-03
- Results posted
- 2021-09-29
Locations
41 sites across 14 countries: United States, Canada, France, Germany, Hungary, Italy, Lebanon, Netherlands, Norway, Poland, Spain, Taiwan, Thailand, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02404441. Inclusion in this directory is not an endorsement.