A Phase II Study of Anlotinib Combined With Penpulimab in Subjects With Gynecological Cancer

NCT05028504 | Unknown Phase 2

• 1 other identifier: ALTERGO020
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 6

Brief Summary

This is a single-arm, open-label, phase II clinical trial to evaluate the efficacy and safety of penpulimab combined with anlotinib in subjects with gynecological cancer, including 23 ovarian cancer，37 endometrial cancer，26 cervical cancer.

Conditions

Gynecological Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)

  up to 96 weeks

Secondary Outcomes (4)

• Progression free survival (PFS)

  up to 96 weeks

• Duration of Response (DOR)

  up to 96 weeks

• Disease control rate（DCR）

  up to 96 weeks

• Overall Survival (OS)

  up to 120 weeks

Study Arms (1)

Penpulimab+Anlotinib

EXPERIMENTAL

Penpulimab 200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules 12mg given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)

Drug: Penpulimab; Drug: Anlotinib

Interventions

Penpulimab DRUG

Penpulimab is a humanized monoclonal antibody targeting programmed cell death-1 (PD-1), which prevents PD-1 from binding to PD-L1 and PD-L2 receptors on tumor cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Penpulimab+Anlotinib

Anlotinib DRUG

A multi-target receptor tyrosine kinase inhibitor

Penpulimab+Anlotinib

Eligibility Criteria

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

You may qualify if:

• Understood and signed an informed consent form;
• years and older, female, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, life expectancy ≥3 months;
• Histopathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer; or endometrial cancer; or cervical cancer (including squamous cell, adenocarcinoma, or adenosquamous cell carcinoma);
• Patients must also meet any of the following conditions:
• Platinum-resistant relapsed or platinum-refractory ovarian cancer, the patient has received at least 1 line of platinum-based chemotherapy after previous cytoreductive surgery;
• With residual disease after surgery or inoperable stage III-IV endometrial cancer, and refused to receive chemoradiation/radiation/chemotherapy; or recurrent endometrial cancer unsuitable or refusing standard therapy;
• Persistent cervical cancer unsuitable for curative treatment, or recurrent/metastatic cervical cancer that refuses to receive standard treatment (for recurrent disease, not yet treated).
• At least one measurable lesion according to the RECIST 1.1;
• Try to provide tumor tissue samples for PD-L1 testing (not required)；
• Demonstrates adequate organ function:
• Blood routine inspection: Hemoglobin (HB) \>= 90 g/L; The absolute value of neutrophil (ANC) \>= 1.5x10\^9/L;Platelets (PLT) \>= 100x10\^9/L;
• Blood biochemical inspection: Serum creatinine (Cr) \<= 1.5 ULN, or creatinine clearance (CCr) \>= 60mL / min; Total bilirubin (TBIL) \<= 1.5 ULN, or direct bilirubin \<= 1.0 ULN; AST and ALT \<= 2.5 ULN.
• Blood coagulation function: Activated partial thromboplastin time, international standardized ratio adn prothrombin time \<=1.5 ULN;
• Cardiac Function: left ventricular ejection fraction (LVEF) \>=50%;
• Women of child-bearing potential must agree to use contraceptive measures (such as intrauterine devices or condoms) during the study and for 6 months after the end of the study, and have a negative serum pregnancy test within 7 days of enrollment, and must be non lactating subjects.

You may not qualify if:

• Has other non-epithelial ovarian tumors or borderline ovarian epithelial tumors; has carcinosarcoma, endometrial leiomyosarcoma, endometrial stromal sarcoma, or other high-grade sarcoma; has small cell carcinoma of the cervix, or clear cell carcinoma;
• Other malignant tumors that have appeared or are currently present within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors;
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX 40, CD137);
• Has received prior therapy with tyrosine kinase inhibitors that target VEGFR, such as pazopanib, sorafenib, regorafenib, apatinib and other drugs; but previous bevacizumab treatment is allowed (only for ovarian cancer cohorts), provided that the treatment is stopped for more than 4 weeks before enrollment;
• Has received prior radiotherapy within 4 weeks prior to enrollment (participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis - a 2-week washout is permitted for palliative radiation to non-CNS disease and vaginal brachytherapy);
• Has received prior hormonal therapy for the treatment of endometrial carcinoma within 1 week before enrollment;
• Expect to use any active vaccine against infectious diseases (such as influenza vaccine, chickenpox vaccine, etc.) within 28 days before the first dose or during the study period;
• Patients received systemic glucocorticoid therapy or other immunosuppressive therapy (dose\> 10mg / day prednisone or other effective hormones) within 14 days before the first dose;
• Active autoimmune diseases that require systemic treatment have occurred within 2 years before the first dose;
• Subjects known to be allergic to the study drug or any of its excipients or have experienced a severe allergic reaction to other monoclonal antibodies;
• Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis;
• Has any bleeding or bleeding event ≥ CTC AE Grade 3 or unhealed wounds, ulcers or fractures within 4 weeks before enrollment;
• Patients with a clear tendency to gastrointestinal bleeding；
• Suspected or definite presence of symptoms or signs of radiation enteritis, and recurrence within 1 year from the end of radiotherapy;
• Patients whose tumors have invaded large blood vessels or poorly demarcated from the blood vessels according to imaging findings (CT/MRI);

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (6)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangdong, Guangdong, 510080, China

RECRUITING

The First Affiliated Hospital of USTC, Anhui Provincial Hospital

Hefei, Hefei, China

RECRUITING

Shaanxi Provincial Cancer Hospital

Xi’an, Shanxi, China

NOT YET RECRUITING

Shaanxi Provincial People's Hospital

Xi’an, Shanxi, China

RECRUITING

Sicchuan cancer hospital

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Interventions

penpulimab; anlotinib

Study Officials

• Guonan Zhang

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guonan Zhang

CONTACT

86-13881866599; zhanggn@hotmail.com

Hong Liu

CONTACT

86-13693447854; liuhaotian12@163.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: Director, Head of Gynecologic Oncology Center, Clinical Professor

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: May 10, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)