Who is sponsoring NCT04965714?

NCT04965714 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT04965714?

Interventions in NCT04965714: Nivolumab, Pegargiminase, Resection.

What condition does NCT04965714 study?

NCT04965714 studies Resectable Hepatocellular Carcinoma.

Is NCT04965714 still recruiting?

NCT04965714 is currently withdrawn. Last updated 16 February 2023.

Last reviewed 2023-02-16 · How we verify

NCT04965714

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

Nivolumab and ADI-PEG 20 Before Surgery for the Treatment of Resectable Liver Cancer

Withdrawn Phase 2 Last updated 16 February 2023

What this trial tests

Phase 2 trial testing Nivolumab in Resectable Hepatocellular Carcinoma. Withdrawn.

Timeline

13 April 2022

Primary endpoint
10 February 2023

10 February 2023

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	13 April 2022
Primary completion	10 February 2023
Estimated completion	10 February 2023
Sites	1 location across United States

Drugs / interventions tested

Nivolumab (nivolumab) — full drug profile →
Pegargiminase — full drug profile →
Resection

Conditions studied

Resectable Hepatocellular Carcinoma — all drugs for Resectable Hepatocellular Carcinoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

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

Sponsor's own description

This phase II trial studies the effect of nivolumab and ADI-PEG 20 before surgery in treating patients with liver cancer that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ADI-PEG 20 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. Giving nivolumab and ADI-PEG 20 before surgery may help control liver cancer.

Publications & conference data

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

Unlocking the Potential of Arginine Deprivation Therapy: Recent Breakthroughs and Promising Future for Cancer Treatment.
Chu YD, Lai MW, Yeh CT. · · 2023 · cited 24× · PMID 37445845 · DOI 10.3390/ijms241310668
Immunotherapy in liver cancer: overcoming the tolerogenic liver microenvironment.
Liu Y, Yang H, Li T, Zhang N. · · 2024 · cited 23× · PMID 39295859 · DOI 10.3389/fimmu.2024.1460282
The Tumor Microenvironment of Hepatocellular Carcinoma: Untying an Intricate Immunological Network.
Volponi C, Gazzillo A, Bonavita E. · · 2022 · cited 10× · PMID 36551635 · DOI 10.3390/cancers14246151
Impact and Novel Perspective of Immune Checkpoint Inhibitors in Patients with Early and Intermediate Stage HCC.
Marzi L, Mega A, Gitto S, Pelizzaro F, et al · · 2022 · cited 10× · PMID 35884392 · DOI 10.3390/cancers14143332
Influence of the Metabolism on Myeloid Cell Functions in Cancers: Clinical Perspectives.
Boyer T, Blaye C, Larmonier N, Domblides C. · · 2022 · cited 3× · PMID 35159363 · DOI 10.3390/cells11030554
Metabolic characteristics in hepatocellular carcinoma: amino acid metabolic reprogramming.
Zhou R, Li Y, Li G, Li Y, et al · · 2026 · PMID 41501789 · DOI 10.1186/s12943-025-02492-7

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease · Phase 2 · not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma · Phase 2 · not yet recruiting

Other recruiting trials for Resectable Hepatocellular Carcinoma

Currently open trials in the same condition.

NCT06569498 — Neoadjuvant Triple Therapy for Resectable HCC · recruiting
NCT06524466 — Neoadjuvant SBRT Combined With Lenvatinib and Pucotenlimab for Resectable Hepatocellular Carcinoma · Phase 2 · active not recruiting
NCT05701488 — SIRT With Tremelimumab and Durvalumab for Resectable HCC · Phase 1 · recruiting
NCT02379377 — 18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant · Phase 1 · recruiting
NCT04856046 — Detection of Plasma DNA Methylation in Peripheral Blood From Patients With Resectable Liver Cancer · active not recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · 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 NCT04965714 (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 M.D. Anderson Cancer Center
Last refreshed: 16 February 2023

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/NCT04965714.

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