Authorised Therapeutic exploratory (Phase II) squamous cell anal carcinoma

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

EU CTIS ID: 2024-514083-31-00

What this study is testing

The primary objective of this clinical trial is to evaluate the clinical complete response (cCR) rate at week 40 from first DCF cycle, defined as no clinical and radiological sign of residual disease.

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

1. Signed and dated informed consent,
6. Locally advanced disease defined as: • Stage III (TxN1 or T4N0) Lymph node can be considered positive if one of the following criteria is satisfied: • Enlargement (largest short-axis diameter > 1 cm for mesorectal nodes, and > 1.5 cm for other nodes) OR, • Heterogeneity or necrosis OR, • Irregular contours OR, • Strong enhancement at magnetic resonance imaging (MRI) OR, • Positivity on positron emission tomography (PET) scan,
7. Patient eligible to the mDCF regimen,
8. Computed tomography (CT) scan performed within 30 days prior inclusion,
9. MRI of pelvis performed within 30 days prior inclusion,
3. Ability to comply with the study protocol in the Investigator’s judgment,

You likely can't join if

1. Previously received chemotherapy or pelvic radiotherapy,
10. Inadequate organ functions: uncontrolled cardiac condition, known cardiac failure, unstable coronaropathy, respiratory failure, and chronic obstructive pulmonary disease,
11. Diabetes with vascular or neurovascular complications,
12. Preexistent peripheral neuropathy or impaired audition,
13. HIV positive patient with CD4 count under 400/mm3 (HIV test is mandatory before inclusion),
14. 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,

See the full eligibility criteria

Who can join

1. Signed and dated informed consent,
6. Locally advanced disease defined as: • Stage III (TxN1 or T4N0) Lymph node can be considered positive if one of the following criteria is satisfied: • Enlargement (largest short-axis diameter > 1 cm for mesorectal nodes, and > 1.5 cm for other nodes) OR, • Heterogeneity or necrosis OR, • Irregular contours OR, • Strong enhancement at magnetic resonance imaging (MRI) OR, • Positivity on positron emission tomography (PET) scan,
7. Patient eligible to the mDCF regimen,
8. Computed tomography (CT) scan performed within 30 days prior inclusion,
9. MRI of pelvis performed within 30 days prior inclusion,
3. Ability to comply with the study protocol in the Investigator’s judgment,
10. PET scan performed within 30 days prior inclusion,
11. Adequate hematologic and end-organ function: defined by the following laboratory test results obtained within 7 days prior to initiation of study treatment:
12. Serum albumin  25 g/L (2.5 g/dL),
13. For patients not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (PTT)  1.5  ULN,
14. Patient affiliated to or beneficiary of French social security health insurance system (PUMA; La protection Universelle Maladie).
2. Age ≥18 years,
4. Performance status ECOG-WHO ≤ 1,
5. Histologically proved squamous cell anal carcinoma,

What rules you out

1. Previously received chemotherapy or pelvic radiotherapy,
10. Inadequate organ functions: uncontrolled cardiac condition, known cardiac failure, unstable coronaropathy, respiratory failure, and chronic obstructive pulmonary disease,
11. Diabetes with vascular or neurovascular complications,
12. Preexistent peripheral neuropathy or impaired audition,
13. HIV positive patient with CD4 count under 400/mm3 (HIV test is mandatory before inclusion),
14. 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,
15. Active tuberculosis,
16. Concomitant treatment with CYP3A4 inhibitor like ritonavir, indinavir, ketoconazole, etc.,
17. Known hypersensitivity or contraindication to any of the study chemotherapy drugs (taxanes, cisplatin, 5-FU, mitomycin, capecitabine) and dihydro pyrimidine dehydrogenase (DPD) complete deficit,
18. Uncontrolled infection or another life-risk condition,
19. Known hearing impairment that contraindicates cisplatin administration,
2. Previously received anti-tumor immunotherapy (HPV vaccination is allowed),
20. Administration of a (attenuated) live vaccine within 28 days of planned start of study therapy of known need for this vaccine during treatment,
21. Administration of prophylactic phenytoin,
22. Inadequate laboratory values: MDRD CrCl < 60 ml/min, neutrophil count < 1500/mm3, platelets < 100.000/mm3, bilirubin 2.5 x ULN, AST/ALT 2.5 x ULN,
23. Previous major surgery (requiring general anesthesia) within 28 days of enrollment.
24. Any immunosuppressive therapy (i.e. corticosteroids > 10 mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy,
25. Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed,
26. Prior allogeneic bone marrow transplantation or prior solid organ transplantation,
27. Known active central nervous system metastases and/or carcinomatous meningitis. Subject with previously treated brain metastases and with radiological and clinical stability are allowed,
28. Previously received an anti-PD-1, anti-PD-L1, or anti-CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) agent,
29. Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of Ezabenlimab (BI 754091) formulation,
3. Metastatic disease,
30. History of colorectal inflammatory disease,
31. History of idiopathic or secondary pulmonary fibrosis (History of radiation pneumonitis in the radiation field fibrosis is permitted), or evidence of active pneumonitis requiring a systemic treatment with 28 days before the planned start of study therapy.
32. History of severe hypersensitivity reactions to other mAbs
33. History of Chronic colorectal inflammatory disease (Ulcerative colitis, Crohn's disease),
34. History of connective disease,
35. History of autoimmune diseases.
4. Diagnosis of additional malignancy within 3 years prior to the inclusion date with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer,
5. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study,
6. Current participation in a study of an investigational agent or in the period of exclusion,
7. 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,
8. 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,
9. Patient under guardianship, curatorship, or under the protection of justice.

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 all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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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.