Actively Recruiting
Efficacy and Safety of AK104 Combined With Pemetrexed, Carboplatin and Recombinant Human Adenovirus 5 Injection in Advanced Recurrent Cervical Cancer: a Multicenter, Single-arm, Prospective Phase II Clinical Study
Led by Fujian Cancer Hospital · Updated on 2024-06-12
37
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fujian Cancer Hospital
Lead Sponsor
Z
Zhangzhou Municipal Hospital of Fujian Province
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a new treatment approach for women with advanced recurrent cervical cancer that has not responded well to previous therapies. This study evaluates the combined use of pemetrexed, carboplatin, recombinant human adenovirus type 5 injection, and AK104, a PD-1/CTLA-4 bispecific antibody, aiming to overcome immune resistance and improve treatment outcomes. The study is a Phase II, single-arm, prospective trial focused on patients with persistent or metastatic cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma who have failed standard treatments. The treatment involves two stages. The Combined Treatment Stage includes local injections of recombinant human adenovirus 5 for five days, followed by intravenous infusions of AK104 on day 1, and pemetrexed and cisplatin on day 2. These cycles repeat every three weeks for four cycles. Afterward, participants enter the Maintenance Treatment Stage, receiving single-agent AK104 every three weeks for up to two years. The treatment schedule is carefully structured to monitor safety and effectiveness. Participants will undergo regular assessments including tumor measurements according to RECIST criteria and monitoring of adverse events. Researchers will evaluate the overall response rate over two years as the primary outcome and progression-free survival as a secondary outcome. Tumor tissue samples will be collected for PD-L1 expression testing. Women of reproductive age must use effective contraception during and after treatment. The study requires adherence to scheduled visits and follow-up for up to two years to assess treatment effects and safety.
CONDITIONS
Brief Title
Efficacy and Safety of AK104 Combined With Chemotherapy and Recombinant Human Adenovirus 5 Injection in Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participants who sign informed consent and can follow scheduled visits and procedures
- Age between 18 and 75 years old
- Histologically or cytologically confirmed persistent, recurrent, or metastatic cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- Failure of at least one standard systemic treatment with documented disease progression
- Not suitable for local treatments like unresectable surgery or definitive concurrent radiotherapy and chemotherapy
- Interval of at least 2 weeks since last systemic treatment and recovery from related adverse events to grade 1 or less (excluding hair loss and fatigue)
- At least one measurable target lesion per RECIST v1.1
- At least one lesion suitable for local injection therapy meeting RECIST v1.1 criteria
- ECOG performance status 0 or 1
- Expected survival time of at least 12 weeks
- Female of reproductive age must use effective contraception during treatment and for 5 months after last dose
- Consent to provide tumor tissue samples for PD-L1 expression testing
- Good organ and hematopoietic function
You will not qualify if you...
- Diagnosis of other malignancies within 5 years except certain skin and thyroid cancers; specific cervical cancer types excluded
- Infection at injection site
- Symptomatic ascites, pleural or pericardial effusion needing drainage
- History or planned organ or bone marrow transplantation
- Active hepatitis B or C infection above defined viral load thresholds
- Central nervous system metastases with symptoms or meningeal involvement
- Life-threatening bleeding events in past 3 months
- Recent serious arterial thrombosis or embolism
- Tumor invasion into major surrounding organs or blood vessels with risk of fistula
- Uncontrolled hypertension or certain heart conditions
- Severe bleeding disorders or current thrombolytic therapy
- History of gastrointestinal perforation, fistula, bowel obstruction, or inflammatory bowel disease
- History of pneumonitis or active pneumonitis
- Active tuberculosis or recent anti-TB therapy
- HIV or active syphilis infection
- Severe uncontrolled infections within 4 weeks before treatment
- Recent use of oral or intravenous antibiotics
- Systemic autoimmune diseases requiring treatment or certain positive autoimmune antibodies
- Recent immunosuppressive drug use excluding specific inhalants or low-dose steroids
- Recent live attenuated vaccine or immune stimulant treatments
- Major surgery within 4 weeks or unhealed wounds
- Uncontrolled metabolic or systemic diseases increasing risk
- Other acute or chronic conditions or lab abnormalities increasing risk or interfering with study
- Previous oncolytic virus or anti-CTLA-4 antibody therapy
- Known allergies to study drugs or components
- Recent investigational drug treatments or anticancer therapies within defined washout periods
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 cycles every 3 weeks
Participants receive a combination of AK104, Pemetrexed, Cisplatin, and local injection of Recombinant Human Adenovirus 5 Injection in repeated 3-week cycles.
5 visits per cycle (local injection on days 1 to 5, infusions on days 1 and 2) for a total of approximately 20 visits
Duration - Up to 2 years
Participants continue treatment with single-drug AK104 every 3 weeks for up to two years.
Visits every 3 weeks
Trial Site Locations
Total: 1 location
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350011
Actively Recruiting
Research Team
Q
Qin Xu
L
Li Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here