MelanomaPhase 4NCT07854522
A Study of QL1706 Combined With OH2 Injection in Perioperative Treatment of Stage III Resectable Acral Melanoma
A Phase 4 study testing Iparomlimab and Tuvonralimab Injection (QL1706) and OH2 Injection(Recombinant Human GM-CSF Oncolytic Type II Herpes Simplex Virus) in people with Melanoma and Acral Melanoma, run by Peking University Cancer Hospital & Institute.
Trial summary
This is a prospective, multicenter, open-label, 1:1 randomized phase II trial enrolling 76 patients with AJCC stage III surgically resectable acral melanoma. Arm A receives neoadjuvant combination of intratumoral OH2 oncolytic HSV2 plus IV QL1706 (Iparomlimab and Tuvonralimab Injection) for 6 q2w cycles before radical… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma, Acral Melanoma
- What is being tested?
- Iparomlimab and Tuvonralimab Injection (QL1706) and OH2 Injection(Recombinant Human GM-CSF Oncolytic Type II Herpes Simplex Virus)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jun 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the written informed consent form.
- Male or female patients aged ≥18 years and ≤75 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically and/or cytologically confirmed resectable Stage III acral melanoma (according to the AJCC 8th edition staging system for cutaneous malignant melanoma) with at least one measurable lesion.
- Expected survival ≥4 months.
- Adequate organ function: a) Hematology (without any blood component or growth factor support within 7 days before the start of study treatment): i. Absolute neutrophil count (ANC) ≥1.5×10⁹/L (1,500/mm³); ii. White blood cell count ≥3.0×10⁹/L; iii. Platelet count >100×10⁹/L (100,000/mm³); iv. Hemoglobin ≥90 g/L. b) Renal: i. Serum creatinine ≤1.5×ULN, or 24-hour creatinine clearance ≥50 mL/min (calculated according to the Cockcroft-Gault formula); ii. Urine protein <2+ or 24-hour urine protein quantification <1.0 g. c) Hepatic: i. Serum total bilirubin (TBil) ≤1.5×ULN; ii. AST and ALT ≤2.5×ULN; iii. Serum albumin (ALB) ≥28 g/L. d) Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN (if the subject is receiving anticoagulant therapy, the subject must be on a stable dose of anticoagulant, and the coagulation parameters [PT/INR and APTT] at screening should be within the expected therapeutic range for the anticoagulant used). e) Cardiac function: i. Left ventricular ejection fraction (LVEF) ≥50%.
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- 6、Female patients of childbearing potential (including those with premature menopause, menopause <2 years, and those who have not undergone surgical sterilization), male patients, and their partners must agree to use effective contraception during the study period, including surgical sterilization, oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicide. All patients must continue contraception for 6 months after the last treatment.
- 8、Subjects with a history of genital herpes must have a 3-month interval after the herpes has resolved.
- 9、Subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.
Who cannot join
- Patients who have previously received treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 agents.
- Patients whose lesions do not meet the volume requirements for intratumoral injection or are unsuitable for intratumoral injection.
- Patients who have received anti-herpes simplex virus therapy (e.g., acyclovir, ganciclovir, valacyclovir, vidarabine) within 4 weeks prior to randomization, except for patients with hepatitis B who are receiving ongoing treatment with entecavir, tenofovir disoproxil fumarate, or adefovir dipivoxil.
- Receipt of a live attenuated vaccine within 4 weeks prior to randomization.
- Use of an investigational drug within 4 weeks prior to randomization.
- Lesions that cannot accommodate an intratumoral injection volume of 1 mL.
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- Receipt of another anti-tumor monoclonal antibody (mAb) therapy within 4 weeks prior to randomization, or failure of adverse events from prior therapy (occurring more than 4 weeks earlier) to recover to ≤ Grade 1.
- Patients with a history of other malignancy (including unknown primary site) within 5 years prior to randomization. Note: Patients with curatively treated Stage 1 or 2 basal/squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ are excluded.
- Patients with known hypersensitivity to the investigational drug, its active ingredients, or excipients.
- Patients who are positive for hepatitis B surface antigen (HBsAg) with a hepatitis B virus DNA copy number >1×10³ copies/mL; patients who test positive for hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody.
- Patients with any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, severe arrhythmia requiring medication, liver, kidney, or metabolic disease.
- Patients with active central nervous system (CNS) metastases. Patients with adequately treated CNS metastases whose neurological symptoms have recovered to ≤ Grade 1 (CTCAE criteria) for at least 2 weeks prior to randomization (excluding residual signs or symptoms related to CNS treatment) may participate in the study. In addition, patients must not be using corticosteroids, or must be on a stable dose of ≤10 mg prednisone/day (or equivalent), or must have tapered to ≤10 mg prednisone/day.
- Patients with autoimmune disease, history of liver or other organ transplantation, active tuberculosis; or patients who have undergone major surgery, live vaccination, or immunotherapy within 4 weeks prior to randomization.
- Tumor invasion of major blood vessels such as iliac or femoral vessels.
- Patients with diseases (e.g., mental illness) or conditions (e.g., alcoholism or drug abuse) that may increase the risk of study drug administration, affect study compliance, or interfere with the interpretation of study results.
- Patients who have received any other investigational product or participated in another interventional clinical trial within 30 days prior to the screening period.
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study; male or female patients unwilling to use effective contraception. Other conditions deemed unsuitable for enrollment by the investigator.
About this study
Official title: Efficacy and Safety of Iparomlimab and Tuvonralimab Injection(Anti-PD-1/CTLA-4 Bispecific Antibody) Combined With Recombinant Human GM-CSF Oncolytic HSV-2 (OH2) Injection (Vero Cells) for Perioperative Treatment of Stage III Resectable Acral Melanoma: A Prospective, Randomized, Controlled, Multicenter Clinical Study
This is a prospective, multicenter, open-label, 1:1 randomized phase II trial enrolling 76 patients with AJCC stage III surgically resectable acral melanoma. Arm A receives neoadjuvant combination of intratumoral OH2 oncolytic HSV2 plus IV QL1706 (Iparomlimab and Tuvonralimab Injection) for 6 q2w cycles before radical surgery, followed by stratified QL1706 adjuvant therapy. Arm B undergoes upfront radical surgery followed by single-agent QL1706 adjuvant therapy for up to 1 year. The primary endpoint is 2-year EFS rate. Secondary endpoints include pathologic response, RFS, OS, and overall safety profile. All patients receive regular imaging follow-up up to 5 years post-surgery.
- Conditions
- Melanoma, Acral Melanoma
- Being tested
- Iparomlimab and Tuvonralimab Injection (QL1706), OH2 Injection(Recombinant Human GM-CSF Oncolytic Type II Herpes Simplex Virus)
- Keywords
- QL1706, OH2, immunotherapy, melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab Injection (QL1706)Drug
A PD-1/CTLA-4 combination antibody produced using MabPair® technology. It contains two engineered monoclonal antibodies (anti-PD-1 IgG4 and anti-CTLA-4 IgG1) expressed at a fixed ratio from a single cell line. Administered intravenously. In the neoadjuvant phase: 3 mg/kg Q2W for 6 cycles. In the adjuvant phase: 5 mg/kg Q3W for up to 1 year. Manufactured by Qilu Pharmaceutical Co., Ltd. Supplied as 50 mg/2 mL vial. Store at 2-8°C, protect from light, do not freeze.
OH2 Injection(Recombinant Human GM-CSF Oncolytic Type II Herpes Simplex Virus)Drug
A genetically modified oncolytic type II herpes simplex virus (HSV2) strain HG52, with ICP34.5 and ICP47 genes deleted to enable selective replication in tumor cells and enhance antitumor immunity, and engineered to express human GM-CSF. Administered via intratumoral injection. Planned dose: 10^7 CCID50/mL, Q2W for up to 6 cycles. Maximum single-visit volume: 8 mL, adjusted based on lesion diameter. Dose may be reduced to 10^6 CCID50/mL in case of ≥ Grade 3 related AEs. Manufactured by Wuhan Binhui Bio-technology Co., Ltd. Supplied as 1 mL/vial. Store at -70°C or below.
| Study group | Role | What they receive |
|---|---|---|
| Experimental:(Neoadjuvant Therapy + Radical Surgery + Postoperative Adjuvant Therapy) | Experimental | Patients receive 6 cycles of neoadjuvant therapy (QL1706 3 mg/kg IV Q2W + OH2 intratumoral injection up to 8 mL Q2W), followed by radical surgery within 2 weeks after the last neoadjuvant dose. Postoperatively, patients with pCR or near pCR receive observation and follow-up; patients with pPR or NR receive adjuvant QL1706 5 mg/kg IV Q3W for up to 1 year (calculated from the first neoadjuvant dose). BRAF-mutant recurrent patients receive dabrafenib + trametinib instead of QL1706 during adjuvant phase. Receives: Drug: Iparomlimab and Tuvonralimab Injection (QL1706); Drug: OH2 Injection(Recombinant Human GM-CSF Oncolytic Type II Herpes Simplex Virus) |
| Active Comparator: (Radical Surgery + Postoperative Adjuvant Therapy) | Active comparator | Patients undergo radical surgery directly after enrollment. Postoperatively, all patients receive adjuvant QL1706 5 mg/kg IV Q3W for up to 1 year (calculated from the first adjuvant dose), unless contraindicated. BRAF-mutant recurrent patients receive dabrafenib + trametinib instead of QL1706 during adjuvant phase. Receives: Drug: Iparomlimab and Tuvonralimab Injection (QL1706) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Event-Free Survival Rate
Event-free survival (EFS) is defined as the time from randomization to the occurrence of any of the following events: disease progression leading to inoperability (development of locally unresectable disease or distant metastasis), local or distant recurrence, melanoma-related or treatment-related death. The occurrence of a new primary melanoma during treatment or follow-up will also be considered an event.
Measured: From randomization up to 2 years
Secondary outcomes (4)
Pathologic Response Rate (pCR, Near pCR, pPR)
Assessment is performed according to the International Neoadjuvant Melanoma Consortium (INMC) scoring system. Partial pathological response (pPR) is defined as viable tumor cells ≥10% and ≤50%. Near pathological complete response (near pCR) is defined as viable tumor cells >0% and <10%. Pathological complete response (pCR) is defined as the absence of viable tumor cells. The aim is to evaluate pathological response rates, including the partial pathological response rate, major pathological response/near pathological complete response rate, and pathological complete response rate.
Measured: At the time of surgery (approximately 12 weeks after enrollment)
Relapse-Free Survival (RFS)
The time from randomization to the first occurrence of any of the following events: disease recurrence (local, regional, or distant metastasis) or death from any cause, whichever occurs first.
Measured: 5 years
Overall Survival (OS)
The time from randomization to death from any cause.
Measured: 5 years
The incidence and severity of adverse events (AEs)
Safety
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854522
- Sponsor's protocol ID
- QL-MLM-QIBA-1001
- Status last verified
- Aug 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Iparomlimab and Tuvonralimab Injection(Anti-PD-1/CTLA-4 Bispecific Antibody) Combined With Recombinant Human GM-CSF Oncolytic HSV-2 (OH2) Injection (Vero Cells) for Perioperative Treatment of Stage III Resectable Acral Melanoma: A Prospective, Randomized, Controlled, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07854522
- Acronym / sponsor ID
- QL-MLM-QIBA-1001
- Conditions
- Melanoma, Acral Melanoma
- Keywords
- QL1706, OH2, immunotherapy, melanoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, open-label, 1:1 randomized phase II trial enrolling 76 patients with AJCC stage III surgically resectable acral melanoma. Arm A receives neoadjuvant combination of intratumoral OH2 oncolytic HSV2 plus IV QL1706 (Iparomlimab and Tuvonralimab Injection) for 6 q2w cycles before radical surgery, followed by stratified QL1706 adjuvant therapy. Arm B undergoes upfront radical surgery followed by single-agent QL1706 adjuvant therapy for up to 1 year. The primary endpoint is 2-year EFS rate. Secondary endpoints include pathologic response, RFS, OS, and overall safety profile. All patients receive regular imaging follow-up up to 5 years post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental:(Neoadjuvant Therapy + Radical Surgery + Postoperative Adjuvant Therapy) | Experimental | Drug: Iparomlimab and Tuvonralimab Injection (QL1706), Drug: OH2 Injection(Recombinant Human GM-CSF Oncolytic Type II Herpes Simplex Virus)Patients receive 6 cycles of neoadjuvant therapy (QL1706 3 mg/kg IV Q2W + OH2 intratumoral injection up to 8 mL Q2W), followed by radical surgery within 2 weeks after the last neoadjuvant dose. Postoperatively, patients with pCR or near pCR receive observation and follow-up; patients with pPR or NR receive adjuvant QL1706 5 mg/kg IV Q3W for up to 1 year (calculated from the first neoadjuvant dose). BRAF-mutant recurrent patients receive dabrafenib + trametinib instead of QL1706 during adjuvant phase. |
| Active Comparator: (Radical Surgery + Postoperative Adjuvant Therapy) | Active comparator | Drug: Iparomlimab and Tuvonralimab Injection (QL1706)Patients undergo radical surgery directly after enrollment. Postoperatively, all patients receive adjuvant QL1706 5 mg/kg IV Q3W for up to 1 year (calculated from the first adjuvant dose), unless contraindicated. BRAF-mutant recurrent patients receive dabrafenib + trametinib instead of QL1706 during adjuvant phase. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily sign the written informed consent form.
- Male or female patients aged ≥18 years and ≤75 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically and/or cytologically confirmed resectable Stage III acral melanoma (according to the AJCC 8th edition staging system for cutaneous malignant melanoma) with at least one measurable lesion.
- Expected survival ≥4 months.
Key exclusion criteria (17 listed)
- Patients who have previously received treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 agents.
- Patients whose lesions do not meet the volume requirements for intratumoral injection or are unsuitable for intratumoral injection.
- Patients who have received anti-herpes simplex virus therapy (e.g., acyclovir, ganciclovir, valacyclovir, vidarabine) within 4 weeks prior to randomization, except for patients with hepatitis B who are receiving ongoing treatment with entecavir, tenofovir disoproxil fumarate, or adefovir dipivoxil.
- Receipt of a live attenuated vaccine within 4 weeks prior to randomization.
- Use of an investigational drug within 4 weeks prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iparomlimab and Tuvonralimab Injection (QL1706)A PD-1/CTLA-4 combination antibody produced using MabPair® technology. It contains two engineered monoclonal antibodies (anti-PD-1 IgG4 and anti-CTLA-4 IgG1) expressed at a fixed ratio from a single cell line. Administered intravenously. In the neoadjuvant phase: 3 mg/kg Q2W for 6 cycles. In the adjuvant phase: 5 mg/kg Q3W for up to 1 year. Manufactured by Qilu Pharmaceutical Co., Ltd. Supplied as 50 mg/2 mL vial. Store at 2-8°C, protect from light, do not freeze. | Drug | Active Comparator: (Radical Surgery + Postoperative Adjuvant Therapy), Experimental:(Neoadjuvant Therapy + Radical Surgery + Postoperative Adjuvant Therapy) |
| OH2 Injection(Recombinant Human GM-CSF Oncolytic Type II Herpes Simplex Virus)A genetically modified oncolytic type II herpes simplex virus (HSV2) strain HG52, with ICP34.5 and ICP47 genes deleted to enable selective replication in tumor cells and enhance antitumor immunity, and engineered to express human GM-CSF. Administered via intratumoral injection. Planned dose: 10^7 CCID50/mL, Q2W for up to 6 cycles. Maximum single-visit volume: 8 mL, adjusted based on lesion diameter. Dose may be reduced to 10^6 CCID50/mL in case of ≥ Grade 3 related AEs. Manufactured by Wuhan Binhui Bio-technology Co., Ltd. Supplied as 1 mL/vial. Store at -70°C or below. | Drug | Experimental:(Neoadjuvant Therapy + Radical Surgery + Postoperative Adjuvant Therapy) |
Primary outcome
2-Year Event-Free Survival Rate
Time frame: From randomization up to 2 years
Event-free survival (EFS) is defined as the time from randomization to the occurrence of any of the following events: disease progression leading to inoperability (development of locally unresectable disease or distant metastasis), local or distant recurrence, melanoma-related or treatment-related death. The occurrence of a new primary melanoma during treatment or follow-up will also be considered an event.
4 secondary outcomes
Pathologic Response Rate (pCR, Near pCR, pPR)
Time frame: At the time of surgery (approximately 12 weeks after enrollment)
Relapse-Free Survival (RFS)
Time frame: 5 years
Overall Survival (OS)
Time frame: 5 years
The incidence and severity of adverse events (AEs)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iparomlimab and Tuvonralimab Injection (QL1706) and OH2 Injection(Recombinant Human GM-CSF Oncolytic Type II Herpes Simplex Virus) in people with Melanoma and Acral Melanoma, run by Peking University Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Year Event-Free Survival Rate (time frame: From randomization up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.