NCT02988440 is a Phase 1 clinical trial of PDR001 in Hepatocellular Carcinoma, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT02988440?

NCT02988440 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02988440?

Interventions in NCT02988440: PDR001, Sorafenib.

What condition does NCT02988440 study?

NCT02988440 studies Hepatocellular Carcinoma.

Is NCT02988440 still recruiting?

NCT02988440 is currently completed. Last updated 19 December 2020.

Last reviewed 2020-12-19 · How we verify

NCT02988440

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Safety and Tolerability of PDR001 in Combination With Sorafenib and to Identify the Maximum Tolerated Dose and/or Phase 2 Dose for This Combination in Advanced Hepatocellular Patients

Completed Phase 1 Last updated 19 December 2020

What this trial tests

Phase 1 trial testing PDR001 in Hepatocellular Carcinoma in 20 participants. Completed in 27 February 2020.

Timeline

20 April 2017

Primary endpoint
27 February 2020

27 February 2020

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	20 April 2017
Primary completion	27 February 2020
Estimated completion	27 February 2020
Sites	9 locations across Hong Kong, Italy, Japan, Taiwan, Germany, Canada, United States, Spain

Drugs / interventions tested

PDR001 — full drug profile →
Sorafenib (SORAFENIB) — full drug profile →

Conditions studied

Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in first line. There will be a dose escalation part and a dose expansion part.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Molecular therapies and precision medicine for hepatocellular carcinoma.
Llovet JM, Montal R, Sia D, Finn RS. · · 2018 · cited 1481× · PMID 30061739 · DOI 10.1038/s41571-018-0073-4
PD-1 and PD-L1 Checkpoint Signaling Inhibition for Cancer Immunotherapy: Mechanism, Combinations, and Clinical Outcome.
Alsaab HO, Sau S, Alzhrani R, Tatiparti K, et al · · 2017 · cited 1206× · PMID 28878676 · DOI 10.3389/fphar.2017.00561
Current perspectives on the immunosuppressive tumor microenvironment in hepatocellular carcinoma: challenges and opportunities.
Lu C, Rong D, Zhang B, Zheng W, et al · · 2019 · cited 327× · PMID 31464625 · DOI 10.1186/s12943-019-1047-6
The Current Landscape of Immune Checkpoint Blockade in Hepatocellular Carcinoma: A Review.
Pinter M, Jain RK, Duda DG. · · 2021 · cited 271× · PMID 33090190 · DOI 10.1001/jamaoncol.2020.3381
Inflammatory Mechanisms of HCC Development.
Refolo MG, Messa C, Guerra V, Carr BI, et al · · 2020 · cited 149× · PMID 32164265 · DOI 10.3390/cancers12030641
Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets.
Luo XY, Wu KM, He XX. · · 2021 · cited 144× · PMID 34006331 · DOI 10.1186/s13046-021-01968-w
Review article: systemic treatment of hepatocellular carcinoma.
Pinter M, Peck-Radosavljevic M. · · 2018 · cited 122× · PMID 30039640 · DOI 10.1111/apt.14913
Immune Checkpoint Inhibitors in the Treatment of HCC.
Donisi C, Puzzoni M, Ziranu P, Lai E, et al · · 2020 · cited 105× · PMID 33585218 · DOI 10.3389/fonc.2020.601240

Verify or expand the search:

Other trials of PDR001

Trials testing the same drug.

NCT07157345 — Testing if PDR-001 Can Safely and Effectively Remove Harmful Brain Protein in Parkinson's Disease · Phase 1 · recruiting
NCT04895748 — DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & · Phase 1 · terminated
NCT04544111 — PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer · Phase 2 · active not recruiting
NCT04237649 — KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors · EARLY_PHASE1 · terminated
NCT04058756 — Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With · Phase 1 · active not recruiting

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
NCT05842174 — Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting
NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors · Phase 3 · recruiting
NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02988440 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 19 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02988440.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing