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Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer

ConditionAnal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDustin Deming

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pembrolizumab

    Drug

    Chemoradiation Pembrolizumab 200mg IV

  • Paclitaxel

    Drug

    Paclitaxel 50 mg/m\^2 IV

  • Carboplatin

    Drug

    Carboplatin AUC 2 IV

  • Radiation

    Radiation

    Delivered as per institutional standards

  • Pembrolizumab

    Drug

    Maintenance Pembrolizumab 400mg IV

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: Pembrolizumab plus carbopltin and paclitaxelExperimental treatment 4 interventions

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Percentage of subjects with treatment emergent grade 3-4 toxicities, as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.

Safety and tolerability will be measured as a percentage of subjects with treatment emergent grade 3-4 toxicities, as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.

Time frame
3 years
2

Assess the overall response rate of weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of anal cancer.

Overall response rate as defined by RECIST 1.1

Time frame
3 years
3

Assess tumor downstaging

Changes in T or N staging per the AJCC V9.0 staging with be assessed comparing pre and post treatment imaging studies.

Time frame
3 years
4

Disease-free survival of patients undergoing this treatment strategy.

Disease free survival is defined as the time from completion of treatment until recurrence of disease as defined by RECIST 1.1 or death as a result of any cause

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dustin Deming

Lead sponsor

Hoosier Cancer Research Network

Sponsor institution

Merck Sharp & Dohme LLC

Collaborator

University of Wisconsin, Madison

Collaborator

Source ClinicalTrials.gov
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