Who is sponsoring NCT05070221?

NCT05070221 is sponsored by Peking University Cancer Hospital & Institute.

What drugs are being tested in NCT05070221?

Interventions in NCT05070221: Recombinant Oncolytic HSV-2 Therapeutic Injecta (Vero Cell) for Human Use (rHSV2hGM-CSF), Recombinant humanized anti-PD-1 monoclonal antibody for injection, Axitinib.

What condition does NCT05070221 study?

NCT05070221 studies Melanoma Stage IV.

Is NCT05070221 still recruiting?

NCT05070221 is currently status unknown. Last updated 7 October 2021.

Last reviewed 2021-10-07 · How we verify

NCT05070221

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

Study of Oncolytic Virus in Combination With HX-008 and Axitinib in Melanoma Patients With Liver Metastasis

Status unknown Phase 1 Last updated 7 October 2021

What this trial tests

Phase 1 trial testing Recombinant Oncolytic HSV-2 Therapeutic Injecta (Vero Cell) for Human Use (rHSV2hGM-CSF) in Melanoma Stage IV in 30 participants. Status unknown.

Timeline

1 October 2021

Primary endpoint
31 October 2023

31 December 2023

Quick facts

Lead sponsor	Peking University Cancer Hospital & Institute
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 October 2021
Primary completion	31 October 2023
Estimated completion	31 December 2023

Drugs / interventions tested

Recombinant Oncolytic HSV-2 Therapeutic Injecta (Vero Cell) for Human Use (rHSV2hGM-CSF) — full drug profile →
Recombinant humanized anti-PD-1 monoclonal antibody for injection — full drug profile →
Axitinib — full drug profile →

Conditions studied

Melanoma Stage IV — all drugs for Melanoma Stage IV →

Sponsor

Peking University Cancer Hospital & Institute

Who can join

Adults 18 to 75, any sex, with Melanoma Stage IV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Malignant melanoma, is a kind of malignant tumor derived from melanocytes. It is common in skin, mucous membrane, eye choroid and other parts. Melanoma is one of the fastest growing malignant tumors with an annual incidence rate of 3-5%. In 2012, there were 232000 new cases of melanoma and 55000 deaths worldwide. Though, the incidence rate of melanoma is relatively low in China, it has been increasing rapidly in recent years. Melanoma has seriously endangering the health of Chinese people. Patients with stage Ⅳ melanoma have a poor prognosis. According to statistics, the median survival time of stage M1a melanoma is 15 months, while stage M1b is 8 months. The median survival time of bone metastasis melanoma is 6 months, while liver and brain metastasis is 4 months. The overall median survival time of metastatic melanoma is only 7.5 months, and the 2-year survival rate is 15%. For patients with advanced melanoma, dacarbazine is the only chemotherapy drug approved by NMPA, but its overall effective rate is only 13.4%, and the median survival time is 5.6 \~ 11 months. Therapies(new drugs or new combination treatments)with higher remission rate and longer survival are urgently needed for patients with advanced melanoma.

Publications & conference data

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

Improving cancer immunotherapy by rationally combining oncolytic virus with modulators targeting key signaling pathways.
Zhu Z, McGray AJR, Jiang W, Lu B, et al · · 2022 · cited 74× · PMID 36221123 · DOI 10.1186/s12943-022-01664-z
Biomaterial-Based In Situ Cancer Vaccines.
Bo Y, Wang H. · · 2024 · cited 55× · PMID 36649567 · DOI 10.1002/adma.202210452
Current clinical landscape of oncolytic viruses as novel cancer immunotherapeutic and recent preclinical advancements.
Yun CO, Hong J, Yoon AR. · · 2022 · cited 45× · PMID 36091031 · DOI 10.3389/fimmu.2022.953410
A Review of Current and Pipeline Drugs for Treatment of Melanoma.
Natarelli N, Aleman SJ, Mark IM, Tran JT, et al · · 2024 · cited 32× · PMID 38399429 · DOI 10.3390/ph17020214
Improving the therapeutic efficacy of oncolytic viruses for cancer: targeting macrophages.
Shen Z, Liu X, Fan G, Na J, et al · · 2023 · cited 24× · PMID 37993941 · DOI 10.1186/s12967-023-04709-z
Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
The cure from within? a review of the microbiome and diet in melanoma.
Kumar P, Brazel D, DeRogatis J, Valerin JBG, et al · · 2022 · cited 17× · PMID 35474500 · DOI 10.1007/s10555-022-10029-3
Oncolytic HSV and cancer drug interactions: Current clinical status and future directions.
Vázquez-Arreguín K, Rivera-Caraballo KA, Ventarapragada D, Chiocca EA, et al · · 2025 · cited 6× · PMID 40702727 · DOI 10.1016/j.ymthe.2025.07.034

Verify or expand the search:

Other trials of Recombinant Oncolytic HSV-2 Therapeutic Injecta (Vero Cell) for Human Use (rHSV2hGM-CSF)

Trials testing the same drug.

NCT05068453 — Study of Oncolytic Virus in Combination With HX-008 and Radiotherapy in Melanoma Patients With Liver Metastasis · Phase 1 · unknown

Other recruiting trials for Melanoma Stage IV

Currently open trials in the same condition.

NCT06319196 — Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma · Phase 2 · recruiting
NCT06204991 — To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma · Phase 1 · recruiting
NCT06444815 — A Study of VET3-TGI in Patients With Solid Tumors · Phase 1 · recruiting
NCT06508775 — Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies · NA · recruiting
NCT05655312 — MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma · Phase 1, PHASE2 · recruiting

Other Peking University Cancer Hospital & Institute trials

Trials by the same sponsor.

NCT07527806 — Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Im · Phase 2 · not yet recruiting
NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
NCT07417241 — SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study · Phase 2 · not yet recruiting
NCT07470203 — Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer · not yet recruiting
NCT07394192 — Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-I · Phase 2 · 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 NCT05070221 (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 Peking University Cancer Hospital & Institute
Last refreshed: 7 October 2021

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/NCT05070221.

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