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A Phase II single arm open label study of Pembrolizumab and Lenvatinib in patients with high risk locally advanced cervix cancer: an EMBRACE high risk study initiative
EU CTIS ID: 2023-506982-73-00
What this study is testing
To evaluate progression free survival (PFS) at 24 months (by investigator assessed RECIST 1.1) in women with high-risk locally advanced cervical cancer treated with chemoradiotherapy and Pembrolizumab followed by Pembrolizumab and Lenvatinib
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- age >18 years
- Criteria for known Hepatitis B and C positive subjects Hepatitis B and C screening tests are not required unless: • Known history of HBV or HCV infection • As mandated by local health authority Hepatitis B positive subjects: • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to inclusion. • Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- High risk defined by either of the criteria: a. Squamous cell carcinoma FIGO 2018 stage IIIA, IIIB, IIIC1-IIIC2 OR b. Adenocarcinoma or adeno-squamous carcinoma Stage IB3-IIIC2.
- Have adequate haematological parameters and organ function
- Have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg.
You likely can't join if
- Patients with locally advanced cervical cancer and signs of organ wall involvement on MRI or non-gastrointestinal fistula.
- WOCBP who has a positive urine pregnancy test within 72 hours prior to adjuvant phase. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note eligible patients for this trial are not WOCBP due to treatment with CRT.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
- Severe hypersensitivity (≥Grade 3) to Pembrolizumab or Lenvatinib and/or any of its excipients.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
See the full eligibility criteria
Who can join
- age >18 years
- Criteria for known Hepatitis B and C positive subjects Hepatitis B and C screening tests are not required unless: • Known history of HBV or HCV infection • As mandated by local health authority Hepatitis B positive subjects: • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to inclusion. • Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- High risk defined by either of the criteria: a. Squamous cell carcinoma FIGO 2018 stage IIIA, IIIB, IIIC1-IIIC2 OR b. Adenocarcinoma or adeno-squamous carcinoma Stage IB3-IIIC2.
- Have adequate haematological parameters and organ function
- Have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg.
- Have measurable disease based on RECIST 1.1 on imaging at diagnosis.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Patients should have been planned for radical chemoradiation and MR guided adaptive brachytherapy with intended treatment completion within 50 days.
- Patients should be deemed suitable for start of Pembrolizumab during chemoradiation and brachytherapy, and for start of Lenvatinib/Pembrolizumab 8 weeks after last brachytherapy as per local investigators assessment.
What rules you out
- Patients with locally advanced cervical cancer and signs of organ wall involvement on MRI or non-gastrointestinal fistula.
- WOCBP who has a positive urine pregnancy test within 72 hours prior to adjuvant phase. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note eligible patients for this trial are not WOCBP due to treatment with CRT.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
- Severe hypersensitivity (≥Grade 3) to Pembrolizumab or Lenvatinib and/or any of its excipients.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Active infection requiring systemic therapy.
- Known history of Human Immunodeficiency Virus (HIV) infection.
- Known concurrent active Hepatitis B (defined as HBsAg positive and detectable HBV DNA) and/or Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA [qualitative]) infection.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Major surgery within 3 weeks prior to first dose of study interventions. Brachytherapy is not considered a major surgery.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has had an allogenic tissue/solid organ transplant.
- Urine protein ≥1 g/24 hours. Note: Participants with proteinuria ≥2+ (≥100 mg/dL) on urine dipstick testing (or urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria.
- If a MUGA or cardiac ultrasound was performed (on clinical indication): having a LVEF below the institutional (or local laboratory) normal range.
- Radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- Prolongation of QTcF interval to >480 ms.
- Clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
- Gastrointestinal malabsorption or any other condition that might affect the absorption of Lenvatinib.
- Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.