QL1706 Plus Lenvatinib in Previously Treated Penile Cancer (NCT07384416) | Clinical Trial Compass
RecruitingPhase 2
QL1706 Plus Lenvatinib in Previously Treated Penile Cancer
China47 participantsStarted 2026-04-10
Plain-language 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.
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.
Who can participate
Age range18 Years – 80 Years
SexMALE
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Inclusion criteria
✓. 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.
✕. 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:
What they're measuring
1
median PFS (median Progression-Free Survival）
Timeframe: From treatment initiation date to first documented disease progression or death from any cause
✕. 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.\*
✕. 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.