Trials Sponsors Conditions Drugs Pricing

Conditions

squamous cell anal carcinoma

Outcome Measures

Primary Outcomes (1)

the Clinical complete response (cCR) 40 weeks from the treatment initiation (the best time to evaluate the local response is 26 weeks from the commencement of standard CRT

Secondary Outcomes (10)

1. Major pathological response: complete response (pCR)/ near-complete response (pnCR) after induction treatment
2. Biological complete response (bCR) after radiotherapy measured by E6/E7 ctDNA monitoring as previously reported by our team
1. Objective response rate (ORR) evaluated by RECIST criteria v1.1 (Appendix 1). ORR is defined as the addition of complete response (CR) and partial response (PR) rates. Disease control rate is defined as the addition of ORR and SD (stable disease).
2. Overall survival (OS). OS is defined as the time between the date of the treatment initiation and death from any cause. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.
3. Biological complete response (bCR). bCR is defined as non-detectable HPV ctDNA.
+5 more secondary outcomes

Interventions

MITOMYCINType not reported

FLUOROURACILType not reported

EzabenlimabType not reported

Registry intervention entries

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

Formulated product
MITOMYCIN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INTRAVESICAL USE
View registry record
Formulated product
FLUOROURACIL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
Ezabenlimab
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
CAPECITABINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry record

Ingredients named in source formulations

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

MITOMYCIN
Named ingredient: Mitomycin
View registry record
FLUOROURACIL
Named ingredient: Fluorouracil
View registry record
Ezabenlimab
Named ingredient: Ezabenlimab
View registry record
CAPECITABINE
Named ingredient: Capecitabine
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed and dated informed consent,
Adequate hematologic and end-organ function: defined by the following laboratory test results obtained within 7 days prior to initiation of study treatment:
Serum albumin  25 g/L (2.5 g/dL),

Sponsors & Collaborators

Centre Hospitalier Regional Universitaire
Type not reportedlead

Study Sites (13)

Centre Hospitalier Regional De Marseille

Marseille, 13005, France

Laetitia DAHAN0491386023 laetitia.dahan@ap-hm.fr

Hopital Nord Franche Comte

Trevenans, 90400, France

Christophe BORG000000000 christophe.borg@efs.sante.fr

Centre Antoine Lacassagne

Nice Cedex 2, 06189, France

Ludovic EVESQUE0492031352

Central Study Contacts

CEC

0381668429 mrebucci@chu-besancon.fr

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

July 1, 2024

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: 2024-514083-31-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 05:07:53 UTC

Documents

D1_PROTOCOLE_2024-514083-31-00

You may not qualify if:

Previously received chemotherapy or pelvic radiotherapy,
Previously received anti-tumor immunotherapy (HPV vaccination is allowed),
Metastatic disease,
Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study,
Pregnancy, breast-feeding or absence/refusal of adequate contraception for fertile patients during the period of treatment and for 6 months from the last treatment administration; men must refrain from donating sperm during this same period. In addition, men who are sexually active with woman of childbearing potential will be instructed to adhere to contraception for a period of 7 months after the last last treatment administration,
Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control (i.e., pregnancy rate of less than 1% per year) during the study,
Patient under guardianship, curatorship, or under the protection of justice.
Inadequate organ functions: uncontrolled cardiac condition, known cardiac failure, unstable coronaropathy, respiratory failure, and chronic obstructive pulmonary disease,
Diabetes with vascular or neurovascular complications,
Preexistent peripheral neuropathy or impaired audition,
Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total HBV core antibody (HBcAb) test at screening, are eligible for the study. Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test,
Active tuberculosis,
Concomitant treatment with CYP3A4 inhibitor like ritonavir, indinavir, ketoconazole, etc.,
Known hypersensitivity or contraindication to any of the study chemotherapy drugs (taxanes, cisplatin, 5-FU, mitomycin, capecitabine) and dihydro pyrimidine dehydrogenase (DPD) complete deficit,
Uncontrolled infection or another life-risk condition,
+17 more criteria

Ezabenlimab (BI 754091) and DCFm (docetaxel, cisplatin and 5-fluorouracil) followed by chemoradiotherapy for the treatment of stage III anal canal cancer. Phase II study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

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 (10)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations