Combining lenvatinib and toripalimab for treating platinum-resistant recurrent ovarian cancer

A Prospective Phase II Clinical Trial of Lenvatinib in Combination With Toripalimab for Patients With Platinum-Resistant Recurrent Ovarian Cancer

This study is testing a new combination of lower doses of lenvatinib and toripalimab to see if it can help people with ovarian cancer that hasn't responded to standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: toripalimab, lenvatinib
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06241105 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a lower initial dosage of lenvatinib in combination with toripalimab for patients with platinum-resistant recurrent ovarian cancer. The aim is to provide a new therapeutic option for individuals facing relapsed ovarian cancer that does not respond to standard platinum-based treatments. Participants will be monitored for measurable lesions and overall health to assess treatment outcomes. The study is designed to gather data on the effectiveness of this combination therapy in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with platinum-resistant recurrent ovarian cancer and measurable disease.

Not a fit: Patients with non-epithelial ovarian cancer or those who are not platinum-resistant may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for patients with limited choices due to platinum resistance.

How similar studies have performed: While this approach is novel, similar combinations have shown promise in other cancer types, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age: 18 to 75 years;
2. Platinum-resistant recurrence of epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
3. According to the RECIST 1.1 criteria, there should be at least one measurable lesion or a CA 125 level of ≥ 70 IU/L.
4. ECOG 0-2；
5. Liver and Kidney Function: Serum creatinine levels should be ≤ 1.5 times the upper limit of the normal range.AST and ALT levels should be ≤ 2.5 times the upper limit of normal, or ≤ 5 times the upper limit of normal if liver metastases are present;total bilirubin should be ≤ 1.5 times the upper limit of the normal range.
6. Participants of reproductive age must consent to the use of effective contraceptive methods throughout the duration of the study.Women of reproductive age must yield a negative result in serum or urine pregnancy tests.Non-lactating patients.
7. Those who are expected to survive longer than 3 months. Patients were unconscious and volunteered to participate in the study.

Exclusion Criteria:

1. Uncontrollable malignant hypertension;
2. Imaging showed that the tumor invaded important blood vessels;
3. Contraindications to the use of antiangiogenic agents;
4. Contraindications to checkpoint inhibitors;
5. Patients presenting with abdominal fistula, gastrointestinal perforation, and pelvic-abdominal abscess;
6. Simultaneous involvement or engagement in another clinical trial within a one-month period that could potentially influence the outcomes of this study.
7. Known hypersensitivity to study-related drugs or their excipients;
8. Individuals with severe heart, liver, kidney, and other serious concurrent diseases that may pose a threat to life;
9. Patients judged by the investigator to be inappropriate for participation in the study.

Where this trial is running

Beijing, Beijing

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

Study contacts

• Principal investigator: Zhi f Feng, PhD — Peking Union Medical College Hospital
• Study coordinator: Xiao Shang, PhD

Conditions Recurrent Ovarian Carcinoma