Trials Sponsors Conditions Drugs Pricing

Conditions

locally advanced cervical carcinoma

Outcome Measures

Primary Outcomes (1)

The primary endpoint is the objective response rate (ORR), defined as the percentage of the participants who achieve a complete response (CR) or partial response (PR) RECIST 1.1

Secondary Outcomes (20)

Progression-free survival (PFS): is defined as the time from date of enrollment until RECIST 1.1-defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier
Progression-free survival (PFS) in participants with PD-L1 high expression: defined as the time from date of of enrollment until RECIST 1.1-defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier
Progression-free survival rate at 2and 3 years: defined as the proportion of participants that are progression-free survival event-free at 2 and 3 years
Progression-free survival at 2 and 3 years in participants with PD-L1 high expression: defined as the proportion of participants that are progression-free survival event-free at 2 and 3 years
Overall Survival (OS): defined as time from enrollment until the date of death due to any cause
+15 more secondary outcomes

Interventions

LIBTAYO 350 mg concentrate for solution for infusion.Type not reported

CISPLATINO SANDOZType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
LIBTAYO 350 mg concentrate for solution for infusion.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry record
Formulated product
CISPLATINO SANDOZ
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

LIBTAYO 350 mg concentrate for solution for infusion.
Named ingredient: cemiplimab
View registry record
CISPLATINO SANDOZ
Named ingredient: Cisplatin
View registry record

Eligibility Criteria

Sexfemale

Age GroupsAdult (18-64)

You may qualify if:

Has read and understand the informed consent form and has given written informed consent prior to any study procedures
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

Sponsors & Collaborators

Fondazione IRCCS Istituto Nazionale Dei Tumori
Type not reportedlead

Study Sites (5)

Azienda Socio Sanitaria Territoriale Lariana

Como, 22100, Italy

Paolo Beretta34907343947 paolo.beretta@asst-lariana.it

Fondazione IRCCS Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Francesco Raspagliesi0223902719 Francesco.Raspagliesi@istitutotumori.mi.it

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, 25123, Italy

Valentina Zizioli

Central Study Contacts

public relation office

0223902772 urp@istitutotumori.mi.it

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

October 7, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-521839-36-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 06:21:35 UTC

Documents

Protocol signature page cadillacc redacted

You may not qualify if:

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 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
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
+6 more criteria

Phase II study of Cemiplimab before and after standard chemoradiotherapy for patients with locally advanced cervical carcinoma. CADILLACC TRIAL

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations