Penile CancerPhase 2NCT07384416
QL1706 Plus Lenvatinib in Previously Treated Penile Cancer
A Phase 2 study testing QL1706 + Lenvatinib in people with Penile Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This phase II clinical study aims to evaluate the efficacy and safety of QL1706 in combination with lenvatinib in patients with previously treated advanced or metastatic penile squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Penile Cancer
- What is being tested?
- QL1706 + Lenvatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 31 Jan 2031
- Phase
- Phase 2
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- Histologically or cytologically confirmed penile squamous cell carcinoma.
- Previous treatment with chemotherapy, immunotherapy, and/or targeted therapy.
- At least one measurable target lesion according to RECIST 1.1 criteria.
- ECOG performance status score of ≤ 2.
- Adequate bone marrow function: Hemoglobin (Hb) ≥ 75 g/L, White Blood Cell count (WBC) ≥ 3.0×10⁹/L, Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L, Platelet count (PLT) ≥ 100×10⁹/L.
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- Adequate organ function:
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and Alkaline Phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN.
- Serum creatinine ≤ 1.5 × ULN.
- Life expectancy of ≥ 12 months.
- No significant history of severe cardiac, pulmonary, hepatic, or other major organ diseases.
- The patient understands the study procedures and provides written informed consent to participate in the study.
Who cannot join
- Participation in any investigational drug study within 4 weeks prior to the start of treatment.
- Concurrent active cancer other than penile squamous cell carcinoma, or a history of other malignancies within the past 5 years, except for the following:
- (1) Cured non-melanoma skin cancer;
- (2) Incidentally discovered, low-risk, and curative tumors, including but not limited to low-risk prostate cancer (T1a, Gleason score <6, PSA <0.5 ng/ml) and superficial bladder cancer;
- (3) Other solid tumors that have undergone curative treatment with no evidence of recurrence or metastasis for 5 years or more.
- Other serious, poorly controlled concurrent illnesses that may be aggravated by the combination therapy, including but not limited to:
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- (1) History of severe or acute exacerbation within the past 6 months involving the cardiovascular, hepatic, respiratory, renal, hematological, endocrine, or neuropsychiatric systems;
- (2) Active infection requiring antibiotic treatment within 2 weeks prior to enrollment;
- (3) Congestive heart failure (Class III-IV);
- (4) Unstable angina or myocardial infarction within the past 6 months;
- (5) Untreated active Hepatitis B virus (HBV) infection. *Note: Subjects with HBV meeting the following criteria are eligible: HBV viral load must be <1000 copies/ml (200 IU/ml) before the first dose, and the subject must receive anti-HBV therapy throughout the study treatment period to prevent reactivation. Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not require prophylactic anti-HBV therapy but require close monitoring for reactivation.*
- (6) Active Hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level above the limit of detection).
- Administration of a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1). *Inactivated seasonal influenza vaccines administered by injection are permitted within 30 days prior to the first dose; however, live attenuated influenza vaccines administered intranasally are not permitted.*
- Diagnosis of immunodeficiency or receipt of systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. *Physiologic doses of corticosteroids (≤10 mg/day prednisone or equivalent) are permitted.*
- History of Human Immunodeficiency Virus (HIV) infection (i.e., positive HIV1/2 antibody test).
- Systemic treatment with Chinese herbal medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to enrollment.
- Active autoimmune disease that has required systemic treatment (e.g., with disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years.
- Any other history, disease, concurrent condition, therapy, or laboratory abnormality that, in the investigator's judgment, might compromise the results, interfere with the subject's full participation throughout the study, or make the subject unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong
Kangbo Huang, 020-15622190220, huangkb@sysucc.org.cn
About this study
Official title: A Phase II Study of QL1706 Combined With Lenvatinib in Patients With Previously Treated Advanced or Metastatic Penile Squamous Cell Carcinoma
This phase II clinical study aims to evaluate the efficacy and safety of QL1706 in combination with lenvatinib in patients with previously treated advanced or metastatic penile squamous cell carcinoma.
The primary objective of the study is to determine the median progression-free survival (PFS) of this regimen according to RECIST 1.1 criteria. Secondary objectives include evaluating objective response rate, disease control rate, overall survival, duration of response, safety, and the rate of conversion surgery.
Read more
All enrolled participants will receive QL1706 plus lenvatinib as induction therapy for up to four treatment cycles (21 days per cycle). After completion of four cycles, tumor response will be assessed by imaging and multidisciplinary team (MDT) evaluation. Patients whose tumors become resectable and who are considered likely to benefit from surgery may undergo conversion surgery. Patients who are not eligible for surgery will continue study treatment.
Following induction therapy or surgery, participants may continue QL1706 plus lenvatinib as continuation therapy. QL1706 will be administered for up to one year, and lenvatinib will be continued until disease progression according to RECIST 1.1, unacceptable toxicity, withdrawal of consent, or investigator decision.
Tumor assessments will be performed using imaging studies such as CT or MRI at scheduled intervals. Safety will be monitored through clinical evaluations, laboratory testing, and adverse event reporting throughout the study.
- Conditions
- Penile Cancer
- Being tested
- QL1706 + Lenvatinib
- Medical subject headings
- Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706 + LenvatinibDrug
Lenvatinib: 8 mg once daily (for body weight <60 kg) or 12 mg once daily (for body weight ≥60 kg).
QL1706: 5 mg/kg, administered by intravenous infusion (iv) on Day 1 of each cycle.
Treatment Cycle: Each cycle is 21 days. After completion of four cycles, tumor response will be assessed by imaging and multidisciplinary team (MDT) evaluation. Patients whose tumors become resectable and who are considered likely to benefit from surgery may undergo conversion surgery. Patients who are not eligible for surgery will continue study treatment.
Following induction therapy or surgery, participants may continue QL1706 plus lenvatinib as continuation therapy. QL1706 will be administered for up to one year, and lenvatinib will be continued until disease progression according to RECIST 1.1, unacceptable toxicity, withdrawal of consent, or investigator decision.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Drug: QL1706 + Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
median PFS (median Progression-Free Survival）
defined as the median time from study enrollment to the first occurrence of any of the following events:
Radiographic disease progression according to RECIST version 1.1, as determined by the investigator;
For patients who undergo conversion surgery, postoperative local recurrence or distant metastasis;
Death from any cause, whichever occurs first.
Conversion surgery itself will not be considered a PFS event.
For participants who have not experienced a PFS event at the time of analysis, PFS will be censored at the date of the last tumor assessment or last follow-up.
Measured: From treatment initiation date to first documented disease progression or death from any cause
Secondary outcomes (5)
ORR (Objective Response Rate）
Measured: Baseline to first documented disease progression, death or last valid tumor assessment
Disease Control Rate
The proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 criteria.
Measured: From baseline until the earliest documented disease progression, death from any cause, or the last valid tumor assessment without prior progression.
Duration of Response
The time interval from the first documentation of confirmed CR or PR to the earliest documented disease progression or death from any cause.
Measured: Time Frame: From date of first confirmed CR/PR until first documented disease progression or death
median overall survival
Median Overall Survival (OS) is defined as the median time interval from the date of treatment initiation to the date of death from any cause. For participants who were alive at the last follow-up or lost to follow-up, OS was censored at the date of the last known alive status.
Measured: From treatment initiation date to death from any cause
Adverse Event Rate
The proportion of participants who experience at least one adverse event during the study treatment period and follow-up period
Measured: From treatment initiation through 30 days after the last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start10 Apr 2026 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384416
- Sponsor's protocol ID
- 2025-FXY-358
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2026
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of QL1706 Combined With Lenvatinib in Patients With Previously Treated Advanced or Metastatic Penile Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07384416
- Acronym / sponsor ID
- 2025-FXY-358
- Conditions
- Penile Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 3 Feb 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 phase II clinical study aims to evaluate the efficacy and safety of QL1706 in combination with lenvatinib in patients with previously treated advanced or metastatic penile squamous cell carcinoma.
The primary objective of the study is to determine the median progression-free survival (PFS) of this regimen according to RECIST 1.1 criteria. Secondary objectives include evaluating objective response rate, disease control rate, overall survival, duration of response, safety, and the rate of conversion surgery.
All enrolled participants will receive QL1706 plus lenvatinib as induction therapy for up to four treatment cycles (21 days per cycle). After completion of four cycles, tumor response will be assessed by imaging and multidisciplinary team (MDT) evaluation. Patients whose tumors become resectable and who are considered likely to benefit from surgery may undergo conversion surgery. Patients who are not eligible for surgery will continue study treatment.
Following induction therapy or surgery, participants may continue QL1706 plus lenvatinib as continuation therapy. QL1706 will be administered for up to one year, and lenvatinib will be continued until disease progression according to RECIST 1.1, unacceptable toxicity, withdrawal of consent, or investigator decision.
Tumor assessments will be performed using imaging studies such as CT or MRI at scheduled intervals. Safety will be monitored through clinical evaluations, laboratory testing, and adverse event reporting throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: QL1706 + Lenvatinib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 80 years.
- Histologically or cytologically confirmed penile squamous cell carcinoma.
- Previous treatment with chemotherapy, immunotherapy, and/or targeted therapy.
- At least one measurable target lesion according to RECIST 1.1 criteria.
- ECOG performance status score of ≤ 2.
Key exclusion criteria (18 listed)
- Participation in any investigational drug study within 4 weeks prior to the start of treatment.
- Concurrent active cancer other than penile squamous cell carcinoma, or a history of other malignancies within the past 5 years, except for the following:
- Other serious, poorly controlled concurrent illnesses that may be aggravated by the combination therapy, including but not limited to:
- Administration of a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1). *Inactivated seasonal influenza vaccines administered by injection are permitted within 30 days prior to the first dose; however, live attenuated influenza vaccines administered intranasally are not permitted.*
- Diagnosis of immunodeficiency or receipt of systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. *Physiologic doses of corticosteroids (≤10 mg/day prednisone or equivalent) are permitted.*
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 |
|---|---|---|
| QL1706 + LenvatinibLenvatinib: 8 mg once daily (for body weight <60 kg) or 12 mg once daily (for body weight ≥60 kg). QL1706: 5 mg/kg, administered by intravenous infusion (iv) on Day 1 of each cycle. Treatment Cycle: Each cycle is 21 days. After completion of four cycles, tumor response will be assessed by imaging and multidisciplinary team (MDT) evaluation. Patients whose tumors become resectable and who are considered likely to benefit from surgery may undergo conversion surgery. Patients who are not eligible for surgery will continue study treatment. Following induction therapy or surgery, participants may continue QL1706 plus lenvatinib as continuation therapy. QL1706 will be administered for up to one year, and lenvatinib will be continued until disease progression according to RECIST 1.1, unacceptable toxicity, withdrawal of consent, or investigator decision. | Drug | treatment |
Primary outcome
median PFS (median Progression-Free Survival）
Time frame: From treatment initiation date to first documented disease progression or death from any cause
defined as the median time from study enrollment to the first occurrence of any of the following events: Radiographic disease progression according to RECIST version 1.1, as determined by the investigator; For patients who undergo conversion surgery, postoperative local recurrence or distant metastasis; Death from any cause, whichever occurs first. Conversion surgery itself will not be considered a PFS event. For participants who have not experienced a PFS event at the time of analysis, PFS will be censored at the date of the last tumor assessment or last follow-up.
5 secondary outcomes
ORR (Objective Response Rate）
Time frame: Baseline to first documented disease progression, death or last valid tumor assessment
Disease Control Rate
Time frame: From baseline until the earliest documented disease progression, death from any cause, or the last valid tumor assessment without prior progression.
Duration of Response
Time frame: Time Frame: From date of first confirmed CR/PR until first documented disease progression or death
median overall survival
Time frame: From treatment initiation date to death from any cause
Adverse Event Rate
Time frame: From treatment initiation through 30 days after the last study drug administration
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 8 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706 + Lenvatinib in people with Penile Cancer, run by Sun Yat-sen University at 1 site in China.
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 12 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Ting Xue (+8618243057370, xueting1@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median PFS (median Progression-Free Survival） (time frame: From treatment initiation date to first documented disease progression or death from any cause). 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 8 May 2026.