AK105 Combined With Anlotinib in Patients With Cervical Cancer

NCT05137171 | Unknown Phase 2

• 1 other identifier: ALTER-GO-025
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of AK105 (anti-PD-1 mab) combined with Anlotinib Hydrochloride in the treatment of persistent, recurrent and metastatic cervical cancer.

Conditions

Cervical Cancer

Keywords

AK105,anlotinib,recurrent,metastatic

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  up to 24 months

Secondary Outcomes (2)

• PFS

  up to 24 months

• OS

  up to 24 months

Study Arms (1)

AK105 and anlortinib

EXPERIMENTAL

AK105 200mg iv q3w;anlotinib 12mg 2w on/1w off po qd;21 days as a cycle until PD,intolerable toxicity, investigator or patient decision to withdraw, non-adherence to treatment or trial procedures.

Drug: AK105 and anlotinib

Interventions

AK105 and anlotinib DRUG

AK105(penpulimab): 200mg, every 3 weeks, 21 days as a treatment cycle;Anlotinib: 12mg, 2 weeks on/1 week off, 21 days as a treatment cycle;Treatment will continue until confirmed radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, non-adherence to treatment or trial procedures.

Also known as: penpulimab and anlotinib

AK105 and anlortinib

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily participated in the study and signed informed consent;
• Age between 18 and 75;
• Agreed to detect the expression status of PD-L1 biomarker;
• ECOG score is 0 or 1, and the expected survival time is not less than 3 months;
• Histologically confirmed recurrent or metastatic squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma with documented disease progression. Note that histological confirmation of the original primary tumor is required by pathological reports;
• Patients with recurrent or metastatic cervical cancer who had received at least once platinum-based systemic chemotherapy were included;
• The patient is not suitable for local treatment (surgery or radiotherapy cannot be performed);
• Patients with measurable lesions as defined in RECIST1.1 criteria;
• The main organs function is well, and the laboratory test indexes meet the following requirements:(1) Routine blood test (no blood transfusion or hematopoietic stimulating factor was used within 7 days before screening) :① Hemoglobin (HB) ≥ 90g/L;② Absolute neutrophil count (ANC) ≥1.5×109/L;③ Platelet (PLT) ≥ 80×109/L;(2) Blood biochemical test (no blood transfusion or albumin within 7 days before screening) :① ALT and AST ≤2.5 × ULN (liver/bone metastasis ≤5 × ULN;Bone metastases ≤5 ULN);② Serum total bilirubin (TBIL) ≤1.5 × ULN;③ Serum Cr≤1.5×ULN or creatinine clearance ≥60 mL /min;(3) Coagulation function test:① Activated partial thrombin time (APTT), international standardized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN;② Doppler ultrasound assessment: left ventricular ejection fraction (LVE F)≥ 50%;
• Any toxic side effects of previous chemotherapy have been recovered to ≤CTCAE1 or baseline level;
• The patient has the ability to take medication orally;
• Women of reproductive age must agree to use a highly effective method of contraception during the study period and for 6 months after the last administration of the study drug;Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;

You may not qualify if:

• Patients with a history or signs of brain metastases;
• Prior use of bevacizumab, antiangiogenic drugs and other antiangiogenic drugs;
• Received anti-tumor monoclonal antibody treatment within 4 weeks before enrollment; Had previously received other PD-1/PD-L1 antibodies and anti-CTLA-4 (cytotoxic T-lymphocyte associated antigen-4) therapy.
• Patients were receiving immunosuppressant or systemic hormone therapy for immunosuppression (dose \> 10mg/ day of prednisone or other equivalent hormone) and were still using 2 weeks prior to enrollment
• Participate in other clinical trials or complete other clinical trials within 4 weeks;
• Abnormal coagulation function (INR \> 2.0, PT \> 16s), bleeding tendency or receiving thrombolytic or anticoagulant therapy;
• Failed to recover from adverse events (except hair loss) after prior medication use;
• The patient has any active autoimmune disease or a history of autoimmune disease;
• Clinical symptoms or diseases of the heart that are not well controlled;
• Congenital or acquired immune deficiency;
• Received chemotherapy, targeted and radiotherapy within 2 weeks before enrollment;
• Concomitant diseases/History:(1) Clinically significant hemoptysis occurred within 3 months before enrollment (hemoptysis \> 50ml per day);Or bleeding symptoms of significant clinical significance or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occultation and above, or suffering from vasculitis, etc.;(2) Arteriovenous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except those who had been cured after intravenous catheterization due to chemotherapy) and pulmonary embolism, etc.;(3) hypertension, which cannot be well controlled by antihypertensive drug therapy (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg);During the first 6 months of randomization, myocardial infarction, severe/unstable angina, NYHA grade 2 or higher cardiac dysfunction, clinically significant ventricular arrhythmias or ventricular arrhythmias, and symptomatic congestive heart failure;(4) Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (e.g., diabetes, pulmonary fibrosis and acute pneumonia);(5) Renal insufficiency: urine protein ≥ ++ indicated by routine urine examination, or confirmed 24-hour urine protein level ≥1.0g; (6) History of live attenuated vaccine vaccination within 28 days prior to initial study administration or expected live attenuated vaccine vaccination during study period;(7) human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS);Active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ mL;Hepatitis C, defined as hcV-RNA higher than the lower limit of assay) or co-infection with hepatitis B and c;(8) Severe infection, including but not limited to bacteremia and severe pneumonia requiring hospitalization, occurred within 4 weeks before the first administration;Active infection with CTCAE grade ≥2 requiring systemic antibiotic treatment within 2 weeks prior to initial administration, or fever of unknown origin \>38.5°C during screening/prior to initial administration (as determined by the investigator, fever due to tumor can be included);Evidence of active tuberculosis infection within 1 year before administration;(9) Have been diagnosed with any other malignant tumor within 3 years prior to entry into the study;(10) Major surgery performed within 28 days before enrollment (tissue biopsy and peripheral venipuncture placement of central venous catheter \[PICC\] required for diagnosis are permitted);
• Subjects who have received or are planning to receive allogeneic bone marrow transplantation or solid organ transplantation;
• Peripheral neuropathy ≥ grade 2;Patients with active brain metastases, cancerous meningitis, spinal cord compression, or diseases of the brain or pia meningeal found by imaging CT or MRI examination at the time of screening (patients with brain metastases who had completed treatment 14 days before enrollment and had stable symptoms could be enrolled, but were confirmed to have no symptoms of cerebral hemorrhage by craniocerebral MRI, CT or venography evaluation);
• There are significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea, and presence of clinically significant intestinal obstruction.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

anlotinib; penpulimab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ruixia Guo, Director

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruixia Guo, Doctor

CONTACT

13525569376; guorx666@163.com

Haifeng Qiu, Doctor

CONTACT

18837158920; haifengqiu120@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

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 30, 2021
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 30, 2021

Record last verified: 2021-11