- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04318717
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
November 21, 2023 updated by: Washington University School of Medicine
Adjuvant Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
This is an open-label, single center, one cohort, non-randomized, phase I/II study.
The aim is to evaluate the efficacy and safety of the combination of hypofractionated radiotherapy (HRT) and pembrolizumab on local tumor control in mucosal melanoma patients.
Treatment effect will be compared with historical radiation therapy-alone control data.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: George Ansstas, M.D.
- Phone Number: 314-362-5677
- Email: gansstas@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Contact:
- George Ansstas, M.D.
- Phone Number: 314-362-5677
- Email: gansstas@wustl.edu
-
Principal Investigator:
- George Ansstas, M.D.
-
Sub-Investigator:
- Matt Spraker, M.D., Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologically or cytologically confirmed mucosal melanoma that has undergone surgical resection. Patient must not have received prior radiation therapy within the area of interest.
- At least 16 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%)
Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,200/mcL
- Platelets ≥ 100,000/mcL
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN)
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Creatinine clearance > 30 mL/min by Cockcroft-Gault
- The effects of pembrolizumab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and 6 months after last dose of pembrolizumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after last dose of pembrolizumab.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
- A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
- Received radiation therapy within the area of interest.
- Currently receiving any other investigational agents.
- Metastatic disease.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of up to 10 mg/day of prednisone or equivalent is approved and does not exclude the patient from the trial.
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, > 10 mg of prednisone per day, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. The use of up to 10 mg/day of prednisone or equivalent is approved and does not exclude the patient from the trial.
- Has a history of (non-infectious) pneumonitis/Interstitial lung disease that required maintenance steroids (>10 mg of prednisone) or current pneumonitis/interstitial lung disease.
- Has received a live vaccine or live-attenuated vaccination within 30 days of planned treatment start. Administration of killed vaccines is allowed.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pembrolizumab + Hypofractionated radiation therapy
|
Pembrolizumab is commercially available
Other Names:
It is preferred to leave at least 48 hours between fractions.
Daily imaging to verify accurate set-up is mandatory.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Local tumor control rate
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of treatment-related grade 3 or greater adverse events
Time Frame: Baseline through 30 days after end of treatment (estimated to be 13 months)
|
Baseline through 30 days after end of treatment (estimated to be 13 months)
|
|
Number of treatment discontinuations due to treatment-related adverse events
Time Frame: Through end of treatment (estimated to be 12 months)
|
Through end of treatment (estimated to be 12 months)
|
|
Relapse-free survival (RFS)
Time Frame: Through completion of follow-up (estimated to be 48 months)
|
-defined as the duration of time from the start date of study treatment to the date of earliest disease relapse or death, whichever occurs first.
Patients who neither relapse nor die by the data cutoff date will be censored at the last follow up date.
|
Through completion of follow-up (estimated to be 48 months)
|
Distant metastasis-free survival
Time Frame: Through completion of follow-up (estimated to be 48 months)
|
-defined as the duration of time from the start date of study treatment to the date of appearance of a distant metastasis or death, whichever occurs first.
Patients who neither develop distant metastasis nor die by the data cutoff date will be censored at the last follow up date.
|
Through completion of follow-up (estimated to be 48 months)
|
Overall survival
Time Frame: Through completion of follow-up (estimated to be 48 months)
|
-defined as the duration of time from the start date of study treatment to death from any cause.
Patients who are alive by the data cutoff date will be censored at the last follow up date.
|
Through completion of follow-up (estimated to be 48 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: George Ansstas, M.D., Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2020
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2030
Study Registration Dates
First Submitted
March 20, 2020
First Submitted That Met QC Criteria
March 20, 2020
First Posted (Actual)
March 24, 2020
Study Record Updates
Last Update Posted (Estimated)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 21, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Pembrolizumab
Other Study ID Numbers
- 202003124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mucosal Melanoma of the Head and Neck
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedMetastatic Melanoma | Stage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage III Mucosal Melanoma of the Head and Neck | Stage IVA Mucosal Melanoma of the Head and Neck | Stage IVB Mucosal Melanoma of the Head and Neck | Stage IVC Mucosal Melanoma...United States
-
National Cancer Institute (NCI)RecruitingMucosal Melanoma | Anal Melanoma | Bladder Melanoma | Cervical Melanoma | Esophageal Melanoma | Gallbladder Melanoma | Mucosal Melanoma of the Head and Neck | Mucosal Melanoma of the Urinary System | Oral Cavity Mucosal Melanoma | Penile Mucosal Melanoma | Rectal Melanoma | Recurrent Mucosal Melanoma | Sinonasal... and other conditionsUnited States, Canada
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Bristol-Myers SquibbOno Pharma USA IncCompletedCancer of Head and Neck | Cancer of the Head | Cancer of the NeckJapan
-
Washington University School of MedicineCelgene CorporationActive, not recruitingHead and Neck Cancer | Squamous Cell Carcinoma of the Head and Neck | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and Neck | Carcinoma, Squamous Cell of the Head and NeckUnited States
-
Bristol-Myers SquibbActive, not recruitingSquamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and NeckFrance
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Peter MacCallum Cancer Centre, AustraliaSanofi; Regeneron Pharmaceuticals; Monash University; University of Adelaide; University...RecruitingNeoplasms | Cutaneous Squamous Cell Carcinoma of the Head and Neck | Non-melanoma Skin Cancer | Cutaneous Squamous Cell CarcinomaAustralia
-
National Cancer Institute (NCI)Not yet recruitingStage II Squamous Cell Carcinoma of the Head and Neck | Stage III Squamous Cell Carcinoma of the Head and Neck | Stage IV Squamous Cell Carcinoma of the Head and NeckUnited States
Clinical Trials on Pembrolizumab
-
University Medical Center GroningenCompleted
-
Incyte CorporationMerck Sharp & Dohme LLCCompletedMelanomaUnited States, France, Italy, United Kingdom, Spain, Belgium, Israel, Mexico, Japan, Canada, Netherlands, Sweden, Korea, Republic of, Australia, Russian Federation, Chile, Germany, Poland, Ireland, New Zealand, Denmark, Switzerland, South Africa
-
Merck Sharp & Dohme LLCCompletedMelanomaAustralia, South Africa, Spain, Sweden
-
Acerta Pharma BVMerck Sharp & Dohme LLCCompletedMetastatic Urothelial CarcinomaUnited States
-
Sichuan UniversityGeneplus-Beijing Co. Ltd.RecruitingNon-small Cell Lung CancerChina
-
Chinese University of Hong KongCompletedAcral Lentiginous MelanomaHong Kong
-
HUYABIO International, LLC.Active, not recruitingNon Small Cell Lung CancerUnited States
-
Presage BiosciencesMerck Sharp & Dohme LLCRecruitingSolid TumorUnited States
-
Prof. Dr. Matthias PreusserUnknownPrimary Central Nervous System LymphomaAustria
-
Samsung Medical CenterRecruiting