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NCT03655002
IRX-2, Cyclophosphamide, and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer
Phase 1 trial testing Cyclophosphamide in Recurrent Hepatocellular Carcinoma in 8 participants. Participants enrolled and being followed up; not accepting new ones.
30 March 2026
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 21 February 2019 |
| Primary completion | 30 March 2026 |
| Estimated completion | 30 March 2026 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Cytokine-based Biologic Agent IRX-2 — full drug profile →
- Nivolumab (nivolumab) — full drug profile →
Conditions studied
- Recurrent Hepatocellular Carcinoma — all drugs for Recurrent Hepatocellular Carcinoma →
- Refractory Liver Carcinoma — all drugs for Refractory Liver Carcinoma →
- Stage IV Hepatocellular Carcinoma AJCC v8 — all drugs for Stage IV Hepatocellular Carcinoma AJCC v8 →
- Stage IVA Hepatocellular Carcinoma AJCC v8 — all drugs for Stage IVA Hepatocellular Carcinoma AJCC v8 →
Sponsor
City of Hope Medical Center
Who can join
18 and older, any sex, with Recurrent Hepatocellular Carcinoma or Refractory Liver Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase Ib trial studies the side effects and best dose of IRX-2 when given together with cyclophosphamide and nivolumab in treating patients with liver cancer that has come back or spread to other parts of the body and does not response to treatment. Biological therapies, such as IRX-2, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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. Giving IRX-2, cyclophosphamide, and nivolumab may work better than the IRX?2 regimen alone in treating patients with hepatocellular carcinoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neoantigens: promising targets for cancer therapy.
Xie N, Shen G, Gao W, Huang Z, et al · · 2023 · cited 713× · PMID 36604431 · DOI 10.1038/s41392-022-01270-x -
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 -
Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.
Vanmeerbeek I, Sprooten J, De Ruysscher D, Tejpar S, et al · · 2020 · cited 179× · PMID 32002302 · DOI 10.1080/2162402x.2019.1703449 -
Hepatocellular Carcinoma Immune Landscape and the Potential of Immunotherapies.
Giraud J, Chalopin D, Blanc JF, Saleh M. · · 2021 · cited 172× · PMID 33815418 · DOI 10.3389/fimmu.2021.655697 -
Inflammatory Mechanisms of HCC Development.
Refolo MG, Messa C, Guerra V, Carr BI, et al · · 2020 · cited 149× · PMID 32164265 · DOI 10.3390/cancers12030641 -
The Role of Immune Checkpoint Blockade in the Hepatocellular Carcinoma: A Review of Clinical Trials.
Ozer M, George A, Goksu SY, George TJ, et al · · 2021 · cited 19× · PMID 34956912 · DOI 10.3389/fonc.2021.801379 -
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 -
A comprehensive review about the utilization of immune checkpoint inhibitors and combination therapy in hepatocellular carcinoma: an updated review.
Sharafi F, Hasani SA, Alesaeidi S, Kahrizi MS, et al · · 2022 · cited 9× · PMID 35999569 · DOI 10.1186/s12935-022-02682-z
Verify or expand the search:
- PubMed search for NCT03655002
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other City of Hope Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03655002 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 City of Hope Medical Center
- Last refreshed: 17 June 2025
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/NCT03655002.
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