Clinical trial

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

Name

K3559

Description

The investigators propose to initiate a study assessing the efficacy and safety of a lower initial dosage of lenvatinib combined with toripalimab in patients suffering from platinum-resistant recurrent ovarian cancer. The objective of this research is to offer a novel therapeutic approach for patients battling relapsed ovarian cancer with platinum resistance.

Trial arms

Trial start

2023-02-01

Estimated PCD

2024-12-31

Trial end

2025-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Lenvatinib+Toripalimab.

Adjustment of Medication Dosage: Throughout the course of treatment, adjustments should be made exclusively to the dosage of the drug Lenvatinib.The starting dosage for lenvatinib is 8 mg, administered orally once a day for a period of four weeks. If no adverse reactions are observed, the dosage can be escalated to 12 mg for individuals weighing over 60 kg. However, if the patient experiences intolerable side effects, the dosage should be decreased back to 8 mg.For individuals weighing less than 60 kg, the maximum dosage is 8 mg per day. Should adverse reactions become intolerable, the dosage may be decreased to 4 mg per day.Withdrawal from the study if still intolerable.

Arms:

Lenvatinib+Toripalimab

Size

Primary endpoint

Progression-Free Survival (PFS)

From the start of treatment to a minimum of 3 years

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Lenvatinib plus Toripalimab', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 69, 'type': 'ESTIMATED'}}

Updated at

2024-02-05

1 organization

1 product

1 indication

Organization

Peking Union Medical College Hospital

Product

Lenvatinib+Toripalimab.

Indication

Recurrent Ovarian Carcinoma