Locally Advanced Cervical CancerPhase 2NCT05799469
Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer
A Phase 2 study testing Envafolimab, Cisplatin and External Beam Radiotherapy (EBRT) in people with Locally Advanced Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
This is a single-arm, single-center, exploratory study, the purpose of this study is to evaluate the efficacy and safety of envafolimab combined with Chemoradiotherapy in participants with locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Envafolimab, Cisplatin and External Beam Radiotherapy (EBRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2027
- Phase
- Phase 2
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject voluntarily joins this study and is able to sign the informed consent form with good compliance;
- Female aged 18-75 years (at the time of signing the informed consent);
- ECOG score of 0-1 within 7 days prior to first study intervention dose;
- Expectation of life ≥ 12 weeks;
- Locally advanced squamous cell carcinoma , adenocarcinoma or adenosquamous -carcinoma of the cervix confirmed by pathological histological or clinical diagnosis according to cervical cancer F IGO stage (2018 version) as I B3 , IIA2 , IIB , I II-IVA stage ;
- Pathological specimens (≥ 18 eligible tissue sections) may be provided for biomarker testing;
Show all 16Show fewer
- No prior surgery for cervical cancer (excluding staging surgery), radiotherapy, chemotherapy, systemic therapy (including investigational agents), or immunotherapy ;
- At least 1 measurable cervical lesion or metastatic lymph node meeting RECIST1.1 target lesion criteria by CT scan or MRI within 28 days prior to treatment;
- Adequate major organ function meeting the following criteria:
- Hematology (need not be transfused within 14 days and hematopoietic stimulating factor drugs within 7 days without correction testing): hemoglobin (Hb) ≥ 90 g/L; absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelets (PLT) ≥ 80 × 109/L;
- Biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum total bilirubin (TBIL) ≤ 1.5 × ULN (in subjects with Gilbert 's syndrome, ≤ 3 × ULN); serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min;
- Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;
- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%;
- Thyroid function is normal，defined as thyroid stimulating hormone (TSH) within normal limits. If baseline TSH is out of normal range, subjects with total T3 (or FT3) and FT4 within normal range can also be enrolled;
- Adequate organ function as judged clinically appropriate for the study by the physician.
- Subjects of childbearing potential must use adequate contraception during this study and for 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating.
Who cannot join
- Patients who had or currently had other malignant tumors within 3 years prior to the start of study treatment;
- Inability to perform (complete) brachytherapy due to anatomy, tumor shape, contraindications, etc.;
- Grade ≥ 1 unresolved toxicity due to any prior therapy (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE 5.0]);
- Subjects with any severe and/or uncontrolled disease. Including:
- Unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
- Patients with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms) and ≥ Grade 2 congestive heart failure (New York Heart Association [NYHA] classification);
Show all 28Show fewer
- Active or uncontrolled serious infection (≥ CTCAE Grade 2 infection);
- Cirrhosis, active hepatitis * ; * active hepatitis (hepatitis B reference: HBsAg positive, and HBV DNA test value more than the upper limit of normal; hepatitis C reference: HCV antibody positive, and HCV viral titer test value more than the upper limit of normal) ; patients with previous HBV infection or cured HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and the absence of HBsAg) are eligible; among patients with positive HCV antibody, patients can participate in this study only when HCV RNA is negative by polymerase chain reaction (PCR); Note: subjects with positive HBsAg or positive anti-HBc or hepatitis C，who are eligible for inclusion need continuous antiviral treatment to prevent virus activation ;
- Previous (non infectious) pneumonia/interstitial lung disease still requires steroid treatment or currently has (non infectious) lung disease;
- Active syphilis;
- Patients with renal failure requiring hemodialysis or peritoneal dialysis;
- Patients with a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L);
- Urine routine showed urine protein ≥ + +, and confirmed 24-hour urine protein > 1.0g;
- Patients who received major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment; or had wounds or fractures that were not healed for a long time;
- Severe arterial/venous thrombotic events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism within 6 months before the start of study treatment;
- Patients who have a history of psychotropic substance abuse and cannot quit or have mental disorders;
- Study treatment related:
- History of live vaccination 28 days prior to start of study treatment or planned live vaccination during the study;
- Patients who have experienced severe hypersensitivity reactions after using monoclonal antibodies;
- Active autoimmune disease requiring systemic therapy (eg, use of therapeutic drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to start of study treatment, with the exception of alternative therapies (eg, thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency);
- Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (prednisone at a dose > 10 mg/day or other equivalent efficacy physiological dose hormone) and continued to use within 2 weeks before the first study dose;
- Patients with a history of active tuberculosis;
- Participating or participating in other clinical investigators;
- Patients who are unable to comply with the trial protocol or cooperate with follow-up according to the investigator 's judgment;
- Patients with a history of severe allergy;
- Known hypersensitivity to active ingredients or excipients of the study drug, such as envafolimab and cisplatin;
- Subjects who have concomitant diseases that, in the investigator 's judgment, would seriously jeopardize the subject' s safety or affect the completion of the study, or who are considered unsuitable for enrollment for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm Exploratory Clinical Study of Envafolimab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer
This is a single-arm, single-center, exploratory study, the purpose of this study is to evaluate the efficacy and safety of envafolimab combined with Chemoradiotherapy in participants with locally advanced cervical cancer.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Envafolimab, Cisplatin, External Beam Radiotherapy (EBRT), Brachytherapy (BT)
- Keywords
- Cervical Cancer, Local advanced, Concurrent chemoradiotherapy, Immune checkpoint inhibitors
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabDrug
Also called KN035
SC
CisplatinDrug
IV infusion
External Beam Radiotherapy (EBRT)Radiation
45-50.4Gy
Brachytherapy (BT)Radiation
Performed according to clinically required dose
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Participants receive envafolimab 150 mg subcutaneously (SC) on Day 1 of each week cycle (QW) for 8 cycles followed by envafolimab 300 mg SC on Day 1 of each 3-week cycle (Q3W) until disease progression, intolerable toxicity, investigator determines that the participant cannot continue to benefit, withdraws informed consent, or envafolimab treatment over 2 years. During the QW dosing period of envafolimab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 45 Gray Units (Gy)with the total duration of radiation treatment not to exceed 56 days. Receives: Drug: Envafolimab; Drug: Cisplatin; Radiation: External Beam Radiotherapy (EBRT); Radiation: Brachytherapy (BT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 as Assessed by the Investigator
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 24 using the entire PFS data up to the cut-off date.
Measured: The cut-off date is event-driven and estimated to be approximately 48 months.
Secondary outcomes (7)
Objective Response Rate(ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
Measured: Up to 2 years
Duration of response (DoR)
The DoR is defined as the time from first response to disease progression or death in the absence of disease progression. First response was defined as first CR or PR was achieved. DoR will be summarized for responding patients and DoR rates (%) at 12, 24, and 36 months will be provided.
Measured: Up to 2 years
Progression-Free Survival (PFS) at Month 12/36
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 12/36 using the entire PFS data up to the cut-off date.
Measured: The cut-off date is event-driven and estimated to be approximately 48 months.
Overall Survival (OS) at Month 12/24/36
OS is the time from randomization to death due to any cause. OS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the OS rate at Month 12/24/36 using the entire OS data up to the cut-off date.
Measured: The cut-off date is event-driven and estimated to be approximately 48 months.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score and Physical Function Score.
The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented.
Measured: Baseline and up to approximately 48 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score.
The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. The change from baseline in EORTC QLQ-CX24 score will be presented.
Measured: Baseline and up to approximately 48 months
Number of participants with adverse events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Measured: Up to approximately 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (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 CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Zhou, Chongqing University Cancer Hospital
- Investigators
- Qi Zhou, PhD, Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799469
- Sponsor's protocol ID
- SMA-CC-001
- Status last verified
- Apr 2023
- First submitted
- 14 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Exploratory Clinical Study of Envafolimab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT05799469
- Acronym / sponsor ID
- SMA-CC-001
- Conditions
- Locally Advanced Cervical Cancer
- Keywords
- Cervical Cancer, Local advanced, Concurrent chemoradiotherapy, Immune checkpoint inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Apr 2023 (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 is a single-arm, single-center, exploratory study, the purpose of this study is to evaluate the efficacy and safety of envafolimab combined with Chemoradiotherapy in participants with locally advanced cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Envafolimab, Drug: Cisplatin, Radiation: External Beam Radiotherapy (EBRT), Radiation: Brachytherapy (BT)Participants receive envafolimab 150 mg subcutaneously (SC) on Day 1 of each week cycle (QW) for 8 cycles followed by envafolimab 300 mg SC on Day 1 of each 3-week cycle (Q3W) until disease progression, intolerable toxicity, investigator determines that the participant cannot continue to benefit, withdraws informed consent, or envafolimab treatment over 2 years. During the QW dosing period of envafolimab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 45 Gray Units (Gy)with the total duration of radiation treatment not to exceed 56 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The subject voluntarily joins this study and is able to sign the informed consent form with good compliance;
- Female aged 18-75 years (at the time of signing the informed consent);
- ECOG score of 0-1 within 7 days prior to first study intervention dose;
- Expectation of life ≥ 12 weeks;
- Locally advanced squamous cell carcinoma , adenocarcinoma or adenosquamous -carcinoma of the cervix confirmed by pathological histological or clinical diagnosis according to cervical cancer F IGO stage (2018 version) as I B3 , IIA2 , IIB , I II-IVA stage ;
Key exclusion criteria (28 listed)
- Patients who had or currently had other malignant tumors within 3 years prior to the start of study treatment;
- Inability to perform (complete) brachytherapy due to anatomy, tumor shape, contraindications, etc.;
- Grade ≥ 1 unresolved toxicity due to any prior therapy (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE 5.0]);
- Subjects with any severe and/or uncontrolled disease. Including:
- Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L);
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 |
|---|---|---|
| EnvafolimabAlso: KN035SC | Drug | treatment arm |
| CisplatinIV infusion | Drug | treatment arm |
| External Beam Radiotherapy (EBRT)45-50.4Gy | Radiation | treatment arm |
| Brachytherapy (BT)Performed according to clinically required dose | Radiation | treatment arm |
Primary outcome
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 as Assessed by the Investigator
Time frame: The cut-off date is event-driven and estimated to be approximately 48 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. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 24 using the entire PFS data up to the cut-off date.
7 secondary outcomes
Objective Response Rate(ORR)
Time frame: Up to 2 years
Duration of response (DoR)
Time frame: Up to 2 years
Progression-Free Survival (PFS) at Month 12/36
Time frame: The cut-off date is event-driven and estimated to be approximately 48 months.
Overall Survival (OS) at Month 12/24/36
Time frame: The cut-off date is event-driven and estimated to be approximately 48 months.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score and Physical Function Score.
Time frame: Baseline and up to approximately 48 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score.
Time frame: Baseline and up to approximately 48 months
Number of participants with adverse events (AEs)
Time frame: Up to approximately 48 months
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 5 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
Not yet recruitingPhase 1/2
Intravenously Administered PROMITIL Combined With Radiotherapy in Patients With Cisplatin-Ineligible Head and Neck Cancer Patients
Head & Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 2
Soylent in Reducing Gastrostomy Tube Rates in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiotherapy
Locally Advanced Head and Neck Carcinoma
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.
Qi Zhou, PhD principal investigator
Chongqing University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab, Cisplatin and External Beam Radiotherapy (EBRT) in people with Locally Advanced Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site 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 16 inclusion and 28 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: opening soon, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Xingtao Long, MD (+8602365075619, longxingtao2009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 as Assessed by the Investigator (time frame: The cut-off date is event-driven and estimated to be approximately 48 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 5 Apr 2023.