QL1706 Plus Lenvatinib in Previously Treated Penile Cancer
ConditionPenile Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Participation in any investigational drug study within 4 weeks prior to the start of treatment.
(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.
Trial design
Design model
Single group
Treatments tested in this trial
QL1706 + Lenvatinib
DrugLenvatinib: 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.
Treatment groups
47 Participants
are divided into 1 treatment groupGroup A: treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From treatment initiation date to first documented disease progression or death from any causeSecondary outcomes
1
ORR (Objective Response Rate）
Time frame
Baseline to first documented disease progression, death or last valid tumor assessment2
Disease Control Rate
The proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 criteria.
Time frame
From baseline until the earliest documented disease progression, death from any cause, or the last valid tumor assessment without prior progression.3
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.
Time frame
Time Frame: From date of first confirmed CR/PR until first documented disease progression or death4
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.
Time frame
From treatment initiation date to death from any causeSponsors and contacts
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Source ClinicalTrials.gov