QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer

NCT04864782 | Terminated Phase 2

• 1 other identifier: QL1604-301
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of PD-1 Inhibitor (QL1604) plus chemotherapy in patients with Stage IV, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin and paclitaxel plus carboplatin.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with adverse events

  The incidence and severity of adverse events (AE),serious adverse events (SAE) and treatment-emergent adverse events (TEAEs) according to CTCAE V5.0

  Up to 90 days from last dose

• Objective response rate (ORR) as assessed by investigator based on RECIST v1.1 and iRECIST

  Objective response rate (ORR) as assessed by investigator based on RECIST v1.1 and iRECIST

  approximately 2 years

Secondary Outcomes (12)

• Progression-free survival (PFS) as assessed by investigator based on RECIST v1.1 and iRECIST

  approximately 2 years

• Overall survival(OS)

  approximately 2 years

• Duration of response(DOR)

  approximately 2 years

• Time to progress (TTP)

  approximately 2 years

• AUC of QL1604

  approximately 1 years

Study Arms (1)

QL1604+Chemotherapy

EXPERIMENTAL

On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of QL1604 200 mg plus Investigator choice of chemotherapy (paclitaxel 175 mg/m\^2 plus cisplatin 70 mg/m\^2 or paclitaxel 175 mg/m\^2 plus carboplatin Area Under the Curve (AUC) 6)

Drug: QL1604; Drug: Paclitaxel injection; Drug: Cisplatin/Carboplatin

Interventions

QL1604 DRUG

Intravenous Infusion

Also known as: PD-1 monoclonal antibody

QL1604+Chemotherapy

Paclitaxel injection DRUG

Intravenous Infusion

QL1604+Chemotherapy

Cisplatin/Carboplatin DRUG

Intravenous Infusion

QL1604+Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years and ≤ 75 years
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 12 weeks.
• At least one measurable lesion (according to RECIST v1.1)
• Cervical squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma diagnosed by histopathology and confirmed by imaging as recurrent or stage ⅣB cervical cancer.
• No brain metastasis, or no meningeal metastasis.
• Patients must have normal function as defined:
• ANC≥1.5\*10\^9/L; PLT≥90\*10\^9/L, Hb≥90 g/L,
• Total Bilirubin (TBIL)≤1.5\*Upper Limit of Normal(ULN), Alanine Transaminase (ALT)and Aspartate Aminotransferase(AST)≤2.5\*ULN.For liver metastasis patients, ALT and AST≤5\*ULN,
• Cr≤ 1.5\*ULN, or creatinine clearance rate ≥50 mL/min,
• Proteinuria \<2+，if proteinuria≥ 2+ and 24 hours total urine protein \< 1.0 g
• LVEF≥ 50%.
• Any unresolved AEs ≤ CTCAE Grade 1 (except alopecia).
• Negative pregnancy test for females of child-bearing potentials.
• Patients with reproductive function agreed to take effective contraceptive measures during the treatment and in 6 months after the end of administration.

You may not qualify if:

• Has received more than 2 courses of palliative chemotherapy for treatment of cervical cancer.
• Has received prior chemoradiotherapy within 3 months before enrollment,or has received prior radiotherapy within 2 weaks before enrollment.
• Has received prior surgery therapy within 2 weaks before enrollment,or has not recovered from the effects of surgery therapy.
• Is currently participating in or has participated in a study of an investigational agent within 4 weeks before enrollment.
• Has any active autoimmune diseases or a history of autoimmune diseases (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included).
• Is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount \> 10 mg / day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment.
• Known history of hypersensitivity to macromolecular protein preparation or any components of the QL1604 formulation, or any components of the study drugs.
• Has uncontrolled clinically significant cardiac and cerebral vascular diseases within 6 months before enrollment, including but not limited to the following: myocardial infarction, severe or unstable angina, coronary artery/peripheral artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack).
• Symptomatic congestive heart failure (New York Heart Association Grade II-IV), or NCI-CTCAE v5.0 ≥ 2 arrhythmia, atrial fibrillation of any grade, or clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention.
• Has active infection or an unexplained fever \> 38.5°C during screening visits( subjects with tumor fever may be enrolled at the discretion of the investigator).
• Hepatitis b surface antigen (HBsAg) positive and/or hepatitis b core antibody (HBcAb) positive and HBVDNA\>103copies/ml, hepatitis c virus antibody positive .
• Known history of human immunodeficiency virus (HIV) infection, or other acquired or congenital immunodeficiency diseases,or has a history of organ transplantation (except corneal transplantation).
• Has been vaccinated with live anti-tumor vaccine, or have received anti-tumor immunotherapy, or may receive other systemic anti-tumor treatments during the study period.
• Peripheral neuropathy≥ CTCAE Grade 2.
• History of psychotropic substance abuse, alcoholism or drug abuse.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangzhou, 510060, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

spartalizumab; Paclitaxel; Cisplatin; Carboplatin

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Jihong Liu, Professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: April 29, 2021
• Study Start: September 23, 2020
• Primary Completion: September 30, 2022
• Study Completion: November 1, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

CN (1)