QL1706 with lenvatinib for previously treated penile cancer

A Phase II Study of QL1706 Combined With Lenvatinib in Patients With Previously Treated Advanced or Metastatic Penile Squamous Cell Carcinoma

This trial tests whether combining QL1706 with lenvatinib can help control advanced or metastatic penile squamous cell carcinoma in people whose disease progressed after prior treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Male
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone, lenvatinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07384416 on ClinicalTrials.gov

What this trial studies

This is a phase II trial giving all participants QL1706 plus oral lenvatinib as induction therapy for up to four 21-day cycles, with tumor response measured by RECIST 1.1. After four cycles, imaging and multidisciplinary team (MDT) review determine whether tumors have become resectable and whether conversion surgery is appropriate. Patients with resectable disease may undergo surgery and others will continue systemic treatment and follow-up. Primary outcome is median progression-free survival, with secondary endpoints including response rates, overall survival, duration of response, safety, and conversion surgery rate.

Who should consider this trial

Good fit: Adults aged 18–80 with histologically confirmed penile squamous cell carcinoma who have received prior therapy, have at least one measurable lesion, ECOG ≤2, and adequate organ and bone marrow function are the intended candidates.

Not a fit: People with non‑squamous penile cancers, poor performance status (ECOG >2), inadequate organ function, life expectancy under 12 months, or who cannot travel to the study site are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combination could prolong time without disease progression and may shrink tumors enough to allow surgical removal in some patients.

How similar studies have performed: Combinations of immune-targeted agents and tyrosine kinase inhibitors have shown activity in various solid tumors, but data specific to penile cancer are limited, so this approach is relatively novel for this disease.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 80 years.
2. Histologically or cytologically confirmed penile squamous cell carcinoma.
3. Previous treatment with chemotherapy, immunotherapy, and/or targeted therapy.
4. At least one measurable target lesion according to RECIST 1.1 criteria.
5. ECOG performance status score of ≤ 2.
6. 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.
7. 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.
8. Life expectancy of ≥ 12 months.
9. No significant history of severe cardiac, pulmonary, hepatic, or other major organ diseases.
10. The patient understands the study procedures and provides written informed consent to participate in the study.

Exclusion Criteria:

1. Participation in any investigational drug study within 4 weeks prior to the start of treatment.
2. 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.
3. 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: 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).
4. 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.\*
5. 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.\*
6. History of Human Immunodeficiency Virus (HIV) infection (i.e., positive HIV1/2 antibody test).
7. 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.
8. Active autoimmune disease that has required systemic treatment (e.g., with disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years.
9. 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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Ting Xue

Conditions Penile Cancer