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New treatment option for Anal Cancer
Official title ctHPVDNA Response-Adapted Chemoradiation +/- Retifanlimab Treatment in Locally-Advanced Anal Cancer
ClinicalTrials.gov ID: NCT07425054
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for anal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is for people who have anal cancer and have not yet had treatment. The regular treatment for people who have anal cancer is chemoradiation therapy (CRT).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically proven stage T1-4N+M0 or T3-T4N0M0 anal canal or anal margin squamous cell carcinoma. This may include tumors...
- Participants with excision of the primary tumor but with node positive disease or residual disease at the primary if T3-T4N0 will be eligible.
- Age ≥18 years
- ECOG performance status 0-2
- Creatinine clearance \>30 ml/min by Cockcroft-Gault Equation.
You likely can't join if
- Any prior pelvic radiation or previous radiation that would result in overlapping radiation fields.
- History of allergic reactions to compounds similar to capecitabine,
- Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it...
- Participants with inflammatory bowel disease, scleroderma, or known homozygosity for DPYD deficiency.
- Participants with a fistula between the tumor and invaded organ
- Participant must not have active autoimmune disease or inflammatory bowel disease that has required systemic treatment in past 2 years
See the full eligibility criteria
Who can join
- Participants must have histologically proven stage T1-4N+M0 or T3-T4N0M0 anal canal or anal margin squamous cell carcinoma. This may include tumors of non-keratinizing histology such as basaloid, transitional cell or...
- Participants with excision of the primary tumor but with node positive disease or residual disease at the primary if T3-T4N0 will be eligible.
- Age ≥18 years
- ECOG performance status 0-2
- Creatinine clearance \>30 ml/min by Cockcroft-Gault Equation.
- HIV-infected participants are eligible if they meet the following eligibility criteria:
- A CD4 T-cell count \>= 200/mm3 and a viral load \< 200 copies/mm3
- No history of AIDS-related complications within past year other than history of low CD4+ T-cell count (\>200/mm3) prior to initiation of combination antiretroviral therapy.
- Participant must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer.
- Participant MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management...
- Participants must be PPD negative. Alternatively, the QuantiFERON-TB assay can be used. An individual is considered positive for M. tuberculosis infection if the IFN-γ response to TB antigens is above the test cut-off...
- Tumor size must be documented based on physical examination including digital rectal exam and/or anoscopy/proctoscopy within 4 weeks prior to enrollment.
- Staging imaging studies must include a PET scan AND either a CT with contrast of the abdomen/pelvis or an MRI with contrast of the pelvis. It is preferred that participants receive contrast. For participants with an...
- Participant must have no history of prior chemotherapy for anal cancer.
- Participant must not have had prior potentially curative surgery (i.e. abdominal-perineal resection) for carcinoma of the anus. However, participants who undergo local excision or excisional biopsy are eligible provided...
- Participant must not be receiving any other standard anti-cancer therapy or experimental agent.
- Participant must not have intercurrent illness including, but not limited to, ongoing or active infection or psychiatric/social situations that, in the judgement of the investigator, would limit compliance with study...
- Participant must not have had significant cardiovascular disease within 6 months prior to enrollment that has not been treated/controlled in the opinion of the treating investigators including myocardial infarction...
- Participant must not have a history of a different malignancy unless they are deemed by the investigator to be at low risk of recurrence.
- Participants who are on anti-coagulation with warfarin within 2 weeks prior to enrollment must use an alternative anti-coagulant if planned to receive Capecitabine, otherwise, they must receive infusional 5-FU.
- NOTE: Low molecular weight heparin is permitted provided the participant's PT/INR is \< 1.5. Participants who will received capecitabine and are on Dilantin for a seizure disorder must have Dilantin levels checked...
- Participants must have normal organ and marrow function as defined below:
- Hemoglobin ≥ 10.0 g/dl
- Platelet count ≥ 100,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
- Total bilirubin must be \ 1.5 X ULN. Note that conjugated bilirubin only needs to be tested if total bilirubin \>1.5 X ULN. Participants with a known history of Gilbert's disease are eligible without regard to bilirubin...
- AST/ALT must be \</= 2.5 X institutional ULN (participants with a known history of Gilbert's disease are eligible without regard to bilirubin and liver function tests at the discretion of the treating physician).
- Albumin \>/= 3.0 g/dL
- Women must not be pregnant or breast-feeding because the study treatment may cause harm to an unborn fetus or breastfeeding child. A female of childbearing potential is defined as any woman, regardless of sexual...
- Participants must have the ability to understand and the willingness to sign a written informed consent document.
- Participants must have testing DPYD deficiency per institutional standards and must not be homozygous for DPYD deficiency.
What rules you out
- Any prior pelvic radiation or previous radiation that would result in overlapping radiation fields.
- History of allergic reactions to compounds similar to capecitabine,
- Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen in the opinion of the...
- Participants with inflammatory bowel disease, scleroderma, or known homozygosity for DPYD deficiency.
- Participants with a fistula between the tumor and invaded organ
- Participant must not have active autoimmune disease or inflammatory bowel disease that has required systemic treatment in past 2 years
- No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody)
- No participants with immunodeficiency or receiving systemic steroid therapy equivalent to \> 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study...
- No live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken...
- Participants must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- Participants must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to retifanlimab.
- Participants are excluded if known to be homozygous for Dihydropyrimidine Dehydronase
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.