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New treatment option for Anal Cancer
Official title Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
ClinicalTrials.gov ID: NCT06493019
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for anal cancer.
Also referred to as Keytruda.
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
- A single arm phase II study of pembrolizumab, carboplatin, paclitaxel, and radiation for the treatment of early-stage anal cancer. There are 2 treatments phases and then surveillance.
- 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
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the...
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 30 days prior to registration.
- Histologically proven stage I (T1N0), IIA (T2N0), IIB (T1/2N1), or IIIA (T3 N0/1) invasive squamous cell carcinoma of the anus by AJCC version 9...
- Patient deemed ineligible for standard of care treatment with 5-fluorouracil (5FU) and mitomycin-C (MMC) concurrently with radiation per treating...
You likely can't join if
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, symptomatic congestive heart...
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years and is not deemed by the investigator to...
- Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit...
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Patients with an active autoimmune disease requiring immunosuppression in the past 2 years.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy equivalent to \> 10mg prednisone per day or any other form of...
See the full eligibility criteria
Who can join
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 30 days prior to registration.
- Histologically proven stage I (T1N0), IIA (T2N0), IIB (T1/2N1), or IIIA (T3 N0/1) invasive squamous cell carcinoma of the anus by AJCC version 9. Stage IIIB/C (T4 N0/1) cancers will also be eligible if less than 5cm in...
- Patient deemed ineligible for standard of care treatment with 5-fluorouracil (5FU) and mitomycin-C (MMC) concurrently with radiation per treating investigator.
- Patient is treatment naïve for anal cancer diagnosis.
- Evaluable disease according to RECIST v1.1 within 30 days prior to registration.
- Archival or newly obtained tissue available for planned correlative analysis. If tissue is not available, people may choose to have a standard of care biopsy to meet eligibility.
- Demonstrate adequate organ function as defined below. All screening labs to be obtained within 30 days prior to registration.
- White blood cell (WBC) ≥ 1500 /mm\^3
- Absolute Neutrophil Count (ANC) ≥ 1500/mm\^3
- Hemoglobin (Hgb)a ≥ 9 g/dL
- Platelets (Plt) ≥ 100,000 g/dL
- Creatinine ≤ 1.5 × upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥30 mL/min for creatinine levels \>1.5 × institutional ULN
- Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN
- Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration.
- Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or use an effective method(s) of contraception. Males able to father a...
- If a subject is HIV-infected, participants must have well-controlled HIV on antiretroviral therapy (ART), defined as:
- Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening
- Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of...
- Participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
- Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study. NOTE: HIV testing is...
- If a subject has evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. If a subject has a history of hepatitis C virus (HCV) infection, it...
- Ability of the subject to understand and comply with study procedures for the entire length of the study, as determined by the enrolling physician or protocol designee.
What rules you out
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric...
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years and is not deemed by the investigator to be at low risk for recurrence. Notes: Participants with basal cell...
- Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug(s). NOTE: breast...
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Patients with an active autoimmune disease requiring immunosuppression in the past 2 years.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy equivalent to \> 10mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to registration. NOTE...
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to registration. Administration of killed vaccines is allowed. Examples of live vaccines include, but are not limited to, the following...
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has received any investigational drug or used an investigational device for the treatment of anal cancer within 30 days prior to registration.
- Has had an allogeneic bone marrow/stem cell or solid organ transplant.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has had prior anti-PD1 immune checkpoint blockade.
- Is taking a contraindicated medication and is unable to discontinue or switch to an alternative medication within 7 days of initiating the study drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- New Brunswick, New Jersey, United States
- Madison, Wisconsin, 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 Indianapolis, Indiana, United States; Baltimore, Maryland, United States; New Brunswick, New Jersey, United States; Madison, Wisconsin, 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.