MedTrace Logo

QL1706 Plus Lenvatinib in Previously Treated Penile Cancer

NCT07384416 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Penile Cancer

Interventions

DRUG

QL1706 + Lenvatinib

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2029-02-01
Completion
2031-01-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07384416 on ClinicalTrials.gov