Lenvatinib Plus Toripalimab for Platinum-Resistant Recurrent Ovarian Cancer

NCT06241105 | Recruiting Phase 2

• 1 other identifier: K3559
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  This term denotes the duration from the initiation of enrollment to the point of neoplasm progression or death.

  From the start of treatment to a minimum of 3 years

Secondary Outcomes (2)

• Overall Survival (OS)

  From the start of treatment to a minimum of 3 years

• Objective Response Rate (ORR)

  From the start of treatment to a minimum of 3 years

Study Arms (1)

Lenvatinib+Toripalimab

EXPERIMENTAL

1. Administer 8 mg of Lenvatinib orally, once a day, for continuous usage; 2. Administer 240mg of Toripalimab via intravenous infusion, first time seven days post-lenvatinib intake, and subsequently every three weeks thereafter.

Drug: Lenvatinib+Toripalimab.

Interventions

Lenvatinib+Toripalimab. DRUG

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.

Lenvatinib+Toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 75 years;
• Platinum-resistant recurrence of epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
• According to the RECIST 1.1 criteria, there should be at least one measurable lesion or a CA 125 level of ≥ 70 IU/L.
• ECOG 0-2；
• 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.
• 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.
• Those who are expected to survive longer than 3 months. Patients were unconscious and volunteered to participate in the study.

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Zhi f Feng, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Shang, PhD

CONTACT

13810073050; shang.mm@163.com

Zhi f Feng, PhD

CONTACT

fengfz1969@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Lenvatinib plus Toripalimab

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 5, 2024
• Study Start: February 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

CN (1)