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Monoclonal Antibodies
AK104 for Cervical Cancer
Phase 2
Recruiting
Led By Michael Frumovitz
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years at time of study entry
Histologically or cytologically confirmed recurrent or metastatic high grade neuroendocrine carcinoma of the cervix with disease progression confirmed by radiologic imaging during or following prior platinum-based doublet chemotherapy, with or without bevacizumab for recurrent or metastatic cervical cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up (up to 6 months) through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will study whether the drug AK104 is effective, safe, and tolerated in treating high grade neuroendocrine cervical cancer in adults.
Who is the study for?
Adults over 18 with recurrent or metastatic high-grade neuroendocrine cervical cancer that worsened after platinum-based chemotherapy can join. They should have tried no more than two systemic therapies and not be candidates for surgery/radiation. Participants need measurable lesions, good performance status, proper organ function, a negative pregnancy test if applicable, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing AK104 (Cadonilimab), an investigational drug given as monotherapy to see how effective and safe it is for patients who've had previous treatments for their advanced cervical cancer. It's an open-label study where everyone gets the same treatment.See study design
What are the potential side effects?
While specific side effects of AK104 are not listed here, similar drugs often cause immune-related reactions affecting organs, infusion reactions like fever or chills, fatigue, potential blood abnormalities, increased risk of infections and possibly allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cervical cancer has returned or spread and worsened after platinum-based chemotherapy.
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Surgery or radiation are not options for my recurrent disease.
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I have had 2 or fewer treatments for my cancer after it returned or spread.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ (up to 6 months) through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~(up to 6 months) through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To establish the progression free survival rate at 6 months (PFS6) in response to AK104 monotherapy in patients with progressive/relapsed high-grade neuroendocrine carcinomas of the cervix
Trial Design
1Treatment groups
Experimental Treatment
Group I: AK104Experimental Treatment1 Intervention
cadonilimab) can help to control neuroendocrine cervical cancer that is recurrent (has come back after treatment) or metastatic (has spread).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AK104
2019
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,328 Total Patients Enrolled
Michael FrumovitzPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with experimental cancer vaccines or drugs that target the immune system.I am 18 years old or older.My cancer can be measured by scans, excluding any previously treated with radiation.My cervical cancer has returned or spread and worsened after platinum-based chemotherapy.Surgery or radiation are not options for my recurrent disease.My cervical cancer is not a high-grade neuroendocrine type.My cancer has spread to my brain or central nervous system.I have tested positive for HIV or have active AIDS.I have an autoimmune disease that could come back.I have a serious heart or brain blood vessel condition.I have lingering side effects from previous cancer treatments.I have had a stem cell or organ transplant in the past.I have not had certain treatments or procedures recently.I haven't taken steroids or immunosuppressants in the last 14 days.I haven't received any live vaccines in the last 30 days.I have had 2 or fewer treatments for my cancer after it returned or spread.My blood, kidney, and liver tests are within normal ranges.I am fully active or restricted in physically strenuous activity but can do light work.I have no active cancers in the last 2 years except for my current one or any skin cancer or early-stage breast cancer that was treated.I have had lung conditions not caused by infections.I have severe kidney swelling not improved by specific treatments.I have not had any infections requiring antibiotics or antivirals in the last 4 weeks.I have an active hepatitis B or C infection.You have had serious allergic reactions to other monoclonal antibodies.You are allergic to any part of the AK104 medication.
Research Study Groups:
This trial has the following groups:- Group 1: AK104
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has AK104 been granted permission by the FDA for use?
"Data related to AK104's safety is limited, so it was categorized with a score of 2. This indicates that while there are some studies confirming its safety, none have been conducted regarding efficacy."
Answered by AI
Are the results of this experiment innovative?
"Since 2019, AK104 has been under clinical evaluation. Initially sponsored by Akeso in 2019 during a trial involving 338 participants, the drug was later approved for Phase 1 & 2 after proving efficacy and safety. Currently there are 15 active research programs spread across 14 cities and 3 countries accepting patients to further investigate this medication's effects."
Answered by AI
Could you provide details regarding prior experiments conducted with AK104?
"Currently, there are 15 live AK104 studies being conducted with 2 of them in their final phase. Most of the relevant research is happening at Blacktown in New South Wales but 34 other sites across the country have an interest in this drug."
Answered by AI
Are there any open opportunities to join this research endeavor?
"Verified. Per the information hosted on clinicaltrials.gov, this medical trial is actively recruiting participants; it was initially posted February 28th 2022 and last modified October 12th 2022. The study requires 18 patients from 1 clinic to be enrolled in order for its purpose to be fulfilled."
Answered by AI
What is the current size of the cohort participating in this clinical trial?
"Affirmative. According to the information hosted on clinicaltrials.gov, this trial is actively seeking patients and was originally posted on February 28th 2022 with a most recent update of October 12th 2022. 18 individuals are being recruited from one site for participation in the study."
Answered by AI
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