Treatment for Intermediate Trophoblastic Tumors using Iparomlimab and Tuvonralimab

Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) in the Treatment of Intermediate Trophoblastic Tumors: A Prospective, Multicenter, Single-arm Trial

This study is testing a new combination treatment for people with intermediate trophoblastic tumors to see if it helps them respond better and live longer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, Iparomlimab, Tuvonralimab, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06941766 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a dual-targeting immunotherapy, Iparomlimab and Tuvonralimab (QL1706), in patients with intermediate trophoblastic tumors. Participants will receive QL1706, administered intravenously every three weeks, with or without chemotherapy, and will undergo maintenance therapy after normalization of hCG levels. The study aims to determine the improvement in complete response rates and survival outcomes, while also assessing the safety profiles of the treatment. Efficacy will be measured through serial β-hCG tests, imaging, and biomarker analysis.

Who should consider this trial

Good fit: Ideal candidates include females aged 18-70 with histologically confirmed intermediate trophoblastic tumors, particularly those with advanced or recurrent disease.

Not a fit: Patients with a life expectancy of less than three months or those with non-gestational trophoblastic tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve response rates and survival outcomes for patients with intermediate trophoblastic tumors.

How similar studies have performed: While this approach is novel in the context of intermediate trophoblastic tumors, similar immunotherapy strategies have shown promise in other cancer types.

Eligibility criteria

Inclusion Criteria:

Females aged 18-70 years. Histologically confirmed placental site trophoblastic tumor (PSTT) or epitheloid trophoblastic tumor (ETT)

For Cohort A:

Stage IV disease (treatment-naïve）, recurrent, or chemotherapy-resistant disease

For Cohort B:

Stage I-III disease requiring adjuvant chemotherapy post-biopsy/surgery, meeting ≥1 of: Abnormal β-hCG 2 weeks post-surgery; Incomplete resection; High-risk features includes: Interval from last pregnancy ≥48 months; Deep myometrial invasion; Mitotic count \>5/HPF; Tumor necrosis.

ECOG score 0-1. Signed informed consent.

Organ Function Requirements:

Hematologic:

WBC ≥3.0×10⁹/L ANC ≥1.5×10⁹/L Platelets ≥80×10⁹/L Hemoglobin ≥8.0 g/dL Creatinine ≤1.5×ULN Total bilirubin ≤1.5×ULN (or direct bilirubin ≤ULN if total bilirubin \>1.5×ULN) AST/ALT ≤2.5×ULN INR/PT/aPTT ≤1.5×ULN (or within therapeutic range if on anticoagulants).

Exclusion Criteria:

Life expectancy \<3 months. Non-gestational trophoblastic tumors. Active malignancy (except if cured ≥3 years prior). Prior immune checkpoint therapy (anti-PD-1/L1, CTLA-4, ICOS, CD40, etc.) or cell-based immunotherapies.

Active autoimmune disease requiring systemic treatment (past 2 years). Exceptions: Hormone replacement (e.g., thyroxine), physiologic corticosteroids (≤10 mg/day prednisone equivalent).

Active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis). Systemic corticosteroids (\>10 mg/day prednisone equivalent) within 14 days. Allowed: Topical/inhaled steroids, prophylactic steroids for contrast allergy.

HIV/AIDS.

Active hepatitis:

HBV DNA \>1,000 IU/mL (unless on stable antiviral therapy with DNA \<1,000 IU/mL).

HCV RNA-positive (unless cured). Active tuberculosis (screening required if suspected). Uncontrolled severe infection (e.g., sepsis, pneumonia requiring hospitalization).

Cardiovascular disease: NYHA Class III/IV heart failure or LVEF \<50%. Uncontrolled hypertension (≥140/90 mmHg despite treatment). Unstable angina, myocardial ischemia, or arterial thromboembolism (≤6 months).

Interstitial lung disease (history or active). Malabsorption syndromes (e.g., chronic diarrhea, bowel obstruction) or GI perforation/fistula (≤6 months).

Psychiatric/social conditions impairing consent or compliance. Allogeneic transplant history. Live vaccines ≤30 days prior to QL1706 or planned during study. Hypersensitivity to monoclonal antibodies or protocol-specified chemotherapies. Pregnancy/lactation. Other conditions deemed to compromise patient safety or study integrity.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yuan Li

Conditions Intermediate Trophoblastic Tumor