A Phase II Study of Anlotinib Combined With Penpulimab in Subjects With Gynecological Cancer (ALTER-GO-020)

December 25, 2023 updated by: Guonan Zhang, Sichuan Cancer Hospital and Research Institute

A Single-arm, Open-label, Multi-cohort, Multi-center Phase II Clinical Study of Anlotinib Combined With Penpulimab in the Treatment of Recurrent or Metastatic Gynecological Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Sub-Investigator:
          • Ninghai Cheng
    • Guangdong
      • Guangdong, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Mian He
          • Phone Number: 86-13719000300
        • Sub-Investigator:
          • Peng Guo
    • Hefei
      • Hefei, Hefei, China
        • Recruiting
        • The First Affiliated Hospital of USTC, Anhui Provincial Hospital
        • Contact:
          • Weidong Zhao
          • Phone Number: 86-13955105591
        • Sub-Investigator:
          • Zhengzheng Chen
    • Shanxi
      • Xi'an, Shanxi, China
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
          • Lihong Chen
          • Phone Number: 86-13689280015
        • Sub-Investigator:
          • Fen Li
      • Xi'an, Shanxi, China
        • Not yet recruiting
        • Shaanxi Provincial Cancer Hospital
        • Contact:
          • Guoqing Wang
          • Phone Number: 86-13892828647
        • Sub-Investigator:
          • Lijuan Hu
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Sicchuan cancer hospital
        • Sub-Investigator:
          • Hong Liu
        • Contact:
          • Hong Liu
          • Phone Number: 86-13693447854
        • Contact:
        • Sub-Investigator:
          • Dengfeng Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Understood and signed an informed consent form;
  • 18 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:

    1. Platinum-resistant relapsed or platinum-refractory ovarian cancer, the patient has received at least 1 line of platinum-based chemotherapy after previous cytoreductive surgery;
    2. 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;
    3. 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:

    1. Blood routine inspection: Hemoglobin (HB) >= 90 g/L; The absolute value of neutrophil (ANC) >= 1.5x10^9/L;Platelets (PLT) >= 100x10^9/L;
    2. 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.
    3. Blood coagulation function: Activated partial thromboplastin time, international standardized ratio adn prothrombin time <=1.5 ULN;
    4. 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.

Exclusion Criteria:

  • 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);
  • Prophylactic use of low dose aspirin (≤100mg/d) and low molecular weight heparin (≤40mg/d) is permitted in patients undergoing thrombolysis or anticoagulant therapy;
  • Has clinically significant thyroid dysfunction before enrollment;
  • Has multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);

  • Has any severe acute complications before enrollment:

    1. Blood pressure control is not ideal (systolic pressure >= 150 mmHg, diastolic pressure >= 100 mmHg);
    2. Patients had Unstable angina pectoris, myocardial infarction, ≥grade 2 congestive heart failure, or arrhythmia requiring treatment (including QTc ≥480 ms) within 6 months before enrollment;
    3. Active or uncontrolled serious infection (≥CTC AE grade 2 infection);
    4. Epidemiological test results during the screening period showed that any of the following is met: * HBsAg positive and HBV DNA exceeds the upper limit of normal value (those who fall within the normal range after antiviral treatment can be included); * Anti-HCV positive and HCV RNA positive; * HIV positive;
    5. Poorly controlled diabetes (fasting blood glucose ≥ grade 2);
    6. Had an arterio / venous thrombotic / carcinothrombotic event within 6 months, such as cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, and Hypertensive crisis or hypertensive encephalopathy;
    7. Exacerbated chronic obstructive pulmonary disease (COPD) or other respiratory diseases that require hospitalization, or have active lung infections and/or acute bacterial or fungal infections that require intravenous antibiotic treatment within 28 days before the first dose.
  • Has participated in other anti-tumor intervention clinical trials within 4 weeks before the first medication;
  • According to the judgement of the researchers, there are other factors that may lead to the termination of the study. For example, other serious diseases including mental disorders need to be treated together, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Penpulimab+Anlotinib
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
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.
Drug: Anlotinib
A multi-target receptor tyrosine kinase inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: up to 96 weeks
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)
up to 96 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: up to 96 weeks
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
up to 96 weeks
Duration of Response (DOR)
Time Frame: up to 96 weeks
Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause
up to 96 weeks
Disease control rate（DCR）
Time Frame: up to 96 weeks
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
up to 96 weeks
Overall Survival (OS)
Time Frame: up to 120 weeks
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
up to 120 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan Cancer Hospital and Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guonan Zhang, Sichuan Cancer Hospital and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALTERGO020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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