Active — Not RecruitingPhase 2

Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma.

France55 participantsStarted 2022-01-04

Plain-language summary

Squamous cell carcinoma of the anus (SCCA) is a rare cancer, however its incidence is increasing worldwide. SCCA is mostly induced by human papillomavirus (HPV) infections (high-risk types such as HPV-16 and -18) and HPV-related oncoproteins (E6 and E7) are expressed in more than 90% of cases. T stage and N stage are recognized prognostic factors for local and/or distant recurrence in SCCA patients treated by CRT. In fact, ≥T3 or ≥N1 anal cancers are associated with as high as 50% disease recurrence rate at 2 years. Since 1996 when concomitant radiotherapy and MMC (mytomicin C) and 5-FU-based chemotherapy demonstrated superiority to radiotherapy alone, no significant progress has been achieved in patients with locally advanced SCCA. Still, phase III study by James et al. reported in 2013 showed that prognosis of SCCA patients treated with this regimen can be improved probably due to a better tumor classification, more precise radiological methods, known as "Will Rogers phenomenon". Based on the above, investigators have designed this phase II trial assessing the feasibility and efficacy of Ezabenlimab (BI 754091) and mDCF chemotherapy combination followed by: * standard chemoradiotherapy in case of low response to induction treatment (\<30% by RECIST criteria) or * additional 2 cycles of mDCF and 1 cycle of Ezabenlimab (BI 754091) followed by hypofractionated radiotherapy in case of high response (≥ 30% by RECIST criteria) in SCCA patients with high-risk locally advanced (stage III) disease. In summary, the first innovative aspect of this research program is to provide a valuable proof of concept study evaluating the feasibility to combine radiotherapy, chemotherapies (docetaxel, cisplatin and 5-fluorouracil) and Ezabenlimab (BI 754091) in patients with stage III squamous cell anal carcinoma. INTERACT-ION study will provide evidence that Ezabenlimab (BI 754091) acts in synergy with mDCF to improve complete response rate, and both with hypofractionated radiotherapy to improve the disease-free survival enhancing TH1 and CD8 T cell immunity.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed and dated informed consent, * Age ≥18 years, * Ability to comply with the study protocol in the Investigator's judgment, * Performance status ECOG-WHO ≤ 1, * Histologically proved squamous cell anal carcinoma, * 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, * Patient eligible to the mDCF regimen, * Computed tomography (CT) scan performed within 30 days prior inclusion, * MRI of pelvis performed within 30 days prior inclusion, * PET scan performed within 30 days prior inclusion, * Adequate hematologic and end-organ function: defined by the following laboratory test results obtained within 7 days prior to initiation of study treatment: * Absolute neutrophil count (ANC) ≥ 1.5 X 109/L (1500/µL), * Platelet count ≥ 100 X 109/L (100.000/µL) without transfusion, * Hemoglobin ≥ 90 g/L (9g/dL); previous transfusion is allowed, * Aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 2.5 X upper limit of normal (ULN), (≤ 5 X upper limit of normal (ULN) if known liver metastases) * Serum bilirubin ≤ 2.5 X ULN (except patients with known G…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical complete response (cCR) at 10 months

Timeframe: 10 months

Trial details

NCT IDNCT04719988

SponsorCentre Hospitalier Universitaire de Besancon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-21

View on ClinicalTrials.gov More Squamous Cell Carcinoma of the Anus Stage III trials