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New treatment option for Penile Cancer
Official title QL1706 Plus Lenvatinib in Previously Treated Penile Cancer
ClinicalTrials.gov ID: NCT07384416
What this study is testing
What is QL1706 + Lenvatinib?
QL1706 + Lenvatinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for penile cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- 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.
You likely can't join if
- 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...
- (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...
- (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:
See the full eligibility 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.
- 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.
- 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...
- 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.
- 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:
- (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: people 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...
- (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...
- 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. \...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.