Locally Advanced Cervical CarcinomaPhase 3AK104-305NCT05235516
A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer
A Phase 3 study testing AK104, EBRT and BT in people with Locally Advanced Cervical Carcinoma, run by Akeso at 9 sites in China.
Trial summary
This study is to evaluate the efficacy and safety of AK104 plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Carcinoma
- What is being tested?
- AK104, EBRT and BT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 636 participants
- Where
- 9 sitesChina
- Study dates
- 21 Jun 2022to May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signs the written informed consent form
- ECOG 0-1
- Life expectancy ≥ 3 months.
- The histological types include squamous cell carcinoma,adenocarcinoma, or adenosquamous cell carcinoma;
- Locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage 3A-4A
- At least one measurable tumor lesion per RECIST v1.1
- Adequate organ function as assessed in the laboratory tests
Who cannot join
- Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.
- FIGO 2018 IVB
- Subjects who had previously undergone total hysterectomy
- Subjects who cannot receive brachytherapy
- Subjects with other active malignancies within 2 years prior to randomization
- Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator
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- Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PDL1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40,CD137, GITR, OX40 targets, etc).
- Subjects who require systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization;
- Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study
- Use of live vaccines within 4 weeks prior to randomization
- Active or potentially recurrent autoimmune disease
- Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Known history of interstitial lung disease or non-infectious pneumonitis
- Pregnant or lactating women.
- Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Xiangya Hospital Central South University
Changsha, Hunan, 410013
Hunan cancer hospital
Changsha, Hunan
West China Second University Hospital
Chengdu, Sichuan, 610041
Guizhou Cancer Hospital
Guiyang, Guizhou, 550000
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310005
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Hubei Cancer Hospital
Wuhan, Hubei, 430079
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer
This study is to evaluate the efficacy and safety of AK104 plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer
- Conditions
- Locally Advanced Cervical Carcinoma
- Being tested
- AK104, EBRT, BT, cisplatin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104Drug
q3w iv
EBRTRadiation
45-50.4Gy
BTRadiation
≥80Gy
cisplatinDrug
qw iv
PlaceboDrug
q3w iv
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Not described Receives: Drug: AK104; Radiation: EBRT; Radiation: BT; Drug: cisplatin |
| placebo arm | Placebo comparator | Not described Receives: Radiation: EBRT; Radiation: BT; Drug: cisplatin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival(PFS) by investigator(INV)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 and/or biopsy
Measured: 54 months
Secondary outcomes (2)
PFS rate at month 36
PFS rate at month 36
Measured: 36 months
Overall Survival(OS)
OS is defined as the time from randomization to death due to any cause.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start21 Jun 2022
- Primary completionMay 2026 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihong Liu, Ph.D, Principal investigator, Sun Yat-sen UniversityYang Xiang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235516
- Sponsor's protocol ID
- AK104- 305
- Acronym
- AK104-305
- Status last verified
- Aug 2024
- First submitted
- 20 Jan 2022
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT05235516
- Acronym / sponsor ID
- AK104-305 / AK104- 305
- Conditions
- Locally Advanced Cervical Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 636 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy and safety of AK104 plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: AK104, Radiation: EBRT, Radiation: BT, Drug: cisplatin |
| placebo arm | Placebo comparator | Radiation: EBRT, Radiation: BT, Drug: cisplatin, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- signs the written informed consent form
- ECOG 0-1
- Life expectancy ≥ 3 months.
- The histological types include squamous cell carcinoma,adenocarcinoma, or adenosquamous cell carcinoma;
- Locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage 3A-4A
Key exclusion criteria (16 listed)
- Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.
- FIGO 2018 IVB
- Subjects who had previously undergone total hysterectomy
- Subjects who cannot receive brachytherapy
- Subjects with other active malignancies within 2 years prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK104q3w iv | Drug | treatment arm |
| EBRT45-50.4Gy | Radiation | placebo arm, treatment arm |
| BT≥80Gy | Radiation | placebo arm, treatment arm |
| cisplatinqw iv | Drug | placebo arm, treatment arm |
| Placeboq3w iv | Drug | placebo arm |
Primary outcome
Progression-Free Survival(PFS) by investigator(INV)
Time frame: 54 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 and/or biopsy
2 secondary outcomes
PFS rate at month 36
Time frame: 36 months
Overall Survival(OS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihong Liu, Ph.D principal investigator
Sun Yat-sen University
Yang Xiang, MD principal investigator
Peking Union Medical College Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK104, EBRT and BT in people with Locally Advanced Cervical Carcinoma, run by Akeso at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival(PFS) by investigator(INV) (time frame: 54 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.