Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
A Phase II Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
1 other identifier
interventional
23
1 country
4
Brief Summary
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. The first treatment phase is the chemoradiation phase (Cycle 1-6, weekly cycles) which is followed by the maintenance phase (Cycle 7-14, 6 week cycles).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2024
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
July 9, 2024
CompletedStudy Start
First participant enrolled
September 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 14, 2029
March 23, 2026
March 1, 2026
2.5 years
June 17, 2024
March 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical complete response rate (cCR) following weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of early-stage anal cancer.
Meets both of the following criteria: 1. There is no documented residual cancer on anoscopy. If residual cancer is suspected, a biopsy must be obtained. 2. No documented residual cancer or new metastatic disease on PET/CT, or if a PET/CT cannot be obtained, CT or MR imaging with contrast can be used. Physiologic PET avidity in the anal canal without evidence of cancer on anoscopy is still consistent with a clinical complete response.
6 months
Secondary Outcomes (4)
Percentage of subjects with treatment emergent grade 3-4 toxicities, as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.
3 years
Assess the overall response rate of weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of anal cancer.
3 years
Assess tumor downstaging
3 years
Disease-free survival of patients undergoing this treatment strategy.
3 years
Study Arms (1)
Pembrolizumab plus carbopltin and paclitaxel
EXPERIMENTALAll patients in the chemoradiation phase will receive a combination of pembrolizumab, carboplatin, and paclitaxel. For the first 6 cycles (a cycle is a week) carboplatin and paclitaxel will be administered by IV every week. Pembrolizumab will be administered by IV on cycles 1 and 4. The next phase is the maintenance phase. This will occur from cycle 7-14 with each cycle being 6 weeks. Pembrolizumab will be administered every cycle.
Interventions
Chemoradiation Pembrolizumab 200mg IV
Paclitaxel 50 mg/m\^2 IV
Delivered as per institutional standards
Eligibility Criteria
You may qualify if:
- 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 diameter.
- 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, subjects 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
- +11 more criteria
You may not qualify if:
- 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 illness/social situation that would limit compliance with study requirements.
- 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 carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (ex. cervical, breast) that have undergone potentially curative therapy are eligible. Participants with carcinoma in situ of the bladder are not eligible. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤8, and PSA \<10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are eligible.
- 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 milk cannot be stored for future use while the mother is being treated on study.
- 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: Topical corticosteroid or inhaled corticosteroids are allowed.
- 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: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid oral vaccine. Intranasal influenza vaccines (e.g., Flu-Mist ®) are live attenuated vaccines and are not allowed. NOTE: No live vaccines may be administered while participating in the trial.
- 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 duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dustin Deminglead
- Merck Sharp & Dohme LLCcollaborator
- University of Wisconsin, Madisoncollaborator
Study Sites (4)
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dustin Deming, MD
University of Wisconsin, Madison
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
June 17, 2024
First Posted
July 9, 2024
Study Start
September 30, 2024
Primary Completion (Estimated)
April 15, 2027
Study Completion (Estimated)
April 14, 2029
Last Updated
March 23, 2026
Record last verified: 2026-03