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Phase II study of Cemiplimab before and after standard chemoradiotherapy for patients with locally advanced cervical carcinoma. CADILLACC TRIAL
EU CTIS ID: 2025-521839-36-00
What this study is testing
The primary objective of CADILACC study is to evaluate the antitumor activity of cemiplimab administered before and after standard CCRT in patients with LACC in terms of objective response rate (ORR), defined as the percentage of the participants who achieve a complete response (CR) or partial response (PR) at the end of mantenance treatment according to RECIST1.1 criteria
- 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
- Has read and understand the informed consent form and has given written informed consent prior to any study procedures
- Has PD-L1 positive (PD-L1 >=1%) tumor
- Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer, including investigational agents, and is immunotherapy-naïve
- Patient must have ECOG performance status of 0 or 1
- Subjects must have measurable disease according to RECIST 1.1
You likely can't join if
- Has histological subtypes other than those allowed per inclusion criterion 2 (eg, sarcoma, small cell carcinoma with neuroendocrine differentiation, non epithelial cancer).
- Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority
- Has had an allogenic tissue/solid organ transplant.
- Has FIGO 2018 Stage IVB disease. Evidence of metastatic disease per RECIST 1.1 including lymph nodes above the L1 cephalad body or in the inguinal region. NOTE: Participants with inguinal lymph node involvement must be exscluded.
- Evidence of metastatic disease per RECIST 1.1 including lymph nodes above the L1 cephalad body, in the inguinal region. Participants with inguinal lymph node involvement should be discussed with Sponsor and may potentially be eligible after confirmation of the Sponsor with participant’s disease details
- Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy
See the full eligibility criteria
Who can join
- Has read and understand the informed consent form and has given written informed consent prior to any study procedures
- Has PD-L1 positive (PD-L1 >=1%) tumor
- Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer, including investigational agents, and is immunotherapy-naïve
- Patient must have ECOG performance status of 0 or 1
- Subjects must have measurable disease according to RECIST 1.1
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: (140 − age) ×(weight in kg) × (0.85 if female)/72 × (serum creatinine in mg/dL)
- Serum bilirubin ≤ 1.5 × ULN; with the following exception: Subjects with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled
- AST, ALT, and alkaline phosphatase < 2.5 x ULN, with the following exceptions: Patients with documented liver metastases: AST and ALT < 5 x ULN o Patients with documented liver or bone metastases: alkaline phosphatase < 5 x ULN
- Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Has provided a tissue sample from a core incisional or excisional biopsy of a tumor lesion
- Subjects must have adequate hematological function: - Absolute neutrophil count (ANC) ≥1500/μL - Platelets ≥100 000/μL - Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La
- Patient must have adequate renal and hepatic function: -Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL/min on the basis of the Cockcroft -Gault glomerular filtration rate estimation: (140 − age) ×(weight in kg) × (0.85 if female)/72 × (serum creatinine in mg/dL); -Serum bilirubin ≤ 1.5 × ULN; with the following exception: Subjects with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled; -AST, ALT, and alkaline phosphatase < 2.5 x ULN, with the following exceptions: Patients with documented liver metastases: AST and ALT < 5 x ULN o Patients with documented liver or bone metastases: alkaline phosphatase < 5 x ULN; -Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Patients must not be pregnant or breastfeeding and agree to use highly effective contraception during the treatment period and for at least 120 days after the last dose of cemiplimab
- Participants must abstain from breastfeeding during the study intervention period and for at least 120 days after the last dose of cemiplimab or placebo and 180 days following the end of chemoradiotherapy
- Age > 18 years
- Life expectancy of at least 3 months
- Has LACC, FIGO 2018 stage IB3-IVA
What rules you out
- Has histological subtypes other than those allowed per inclusion criterion 2 (eg, sarcoma, small cell carcinoma with neuroendocrine differentiation, non epithelial cancer).
- Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority
- Has had an allogenic tissue/solid organ transplant.
- Has FIGO 2018 Stage IVB disease. Evidence of metastatic disease per RECIST 1.1 including lymph nodes above the L1 cephalad body or in the inguinal region. NOTE: Participants with inguinal lymph node involvement must be exscluded.
- Evidence of metastatic disease per RECIST 1.1 including lymph nodes above the L1 cephalad body, in the inguinal region. Participants with inguinal lymph node involvement should be discussed with Sponsor and may potentially be eligible after confirmation of the Sponsor with participant’s disease details
- Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy
- Has bilateral severe hydronephrosis, unless at least one side has been stented or resolved by positioning of nephrostomy or considered mild and not clinically significant in the opinion of the investigator
- Has anatomy or tumor geometry or any other reason or contraindication that cannot be treated with intracavitary brachytherapy or a combination of intracavitary and interstitial brachytherapy
- Has received a live vaccine within 30 days prior to the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and areallowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed
- Has received treatment with systemic immunostimulatory agents, colony stimulating factors, interferons, interleukins and vaccine combinations within 6 weeks or 5 half-live of the drug, whichever is shorter, prior to Cycle 1, Day 1
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with anagent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization. NOTE: Participants who have entered the Follow-up Phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization
- Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results, and in the judgment of the investigator or Sponsor, would make the participant inappropriate for entry into this study.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
- Has any contraindication to the use of cisplatin
- Has a 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 the first dose of study medication.
- Has a 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 (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). NOTE: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has a known history of HIV infection. NOTE: No testing for HIV is required unless mandated by local health authority
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, 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.