Une étude sur la radiothérapie et le cemiplimab pour les personnes atteintes d'un cancer de la peau
Un essai clinique de phase II, multicentrique, à un seul bras sur la radiothérapie et CeMiPlimAb : immunothérapie Rwlc pour le carcinome épidermoïde cutané localement avancé et non résécable : RAMPART
The purpose of the study is to see if the combination of radiation therapy and cemiplimab immunotherapy is an effective treatment for people with locally advanced, unresectable CSCC.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado (Data Collection Only)
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Florida
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Tampa, Florida, États-Unis, 33612
- Moffitt Cancer Center (Data Collection Only)
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New Jersey
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Basking Ridge, New Jersey, États-Unis, 07920
- Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)
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Middletown, New Jersey, États-Unis, 07748
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
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Montvale, New Jersey, États-Unis, 07645
- Memorial Sloan Kettering Bergen (All protocol activities)
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New York
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Commack, New York, États-Unis, 11725
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
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Harrison, New York, États-Unis, 10604
- Memorial Sloan Kettering Westchester (All Protocol Activities)
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New York, New York, États-Unis, 10065
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Rockville Centre, New York, États-Unis, 11553
- Memorial Sloan Kettering Nassau (All protocol activities)
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic (Data Collection Only)
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19111
- Fox Chase Cancer Center (Data Collection Only)
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
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Washington
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Seattle, Washington, États-Unis, 98109
- University of Washington (Data Collection Only)
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
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Biopsy proven cutaneous squamous cell carcinoma which is locally advanced
- Mixed histology tumors that are predominantly squamous cell carcinoma are eligible
- Locally advanced primary tumor is T3-T4 and/or N+ by AJCC and/or UICC 8th edition clinical criteria
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T3-T4 primary tumor characteristics noted below:
- Non-eyelid tumor >4 cm in maximum dimension or with bone erosion or invasion, perineural invasion of nerve 0.1 mm or larger, or invasion beyond subcutaneous fat or >6 mm from granular layer of adjacent normal epidermis
- Eyelid tumor >2 cm or invading adjacent ocular, orbital or facial structures
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≥18 years old
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Unresectable or medically inoperable according to local multidisciplinary consensus for reasons such as:
- Tumor or regional lymph node metastases that has recurred despite ≥2 prior surgical procedures, with another curative resection unlikely
- Tumor or nodal disease with significant local invasion that precludes complete resection
- Tumor or nodal disease in anatomically challenging area where surgery may result in significant disfigurement or dysfunction (amputation of nose, ear, eye, digit, limb, etc)
- Medical contraindication to surgery
- Patient refusal of surgery due to anticipate morbidity
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ECOG ≤2
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Adequate bone marrow and metabolic function (by blood tests)
- Total bilirubin ≤1.5 x upper limit of normal
- Aspirate aminotransferase (AST) ≤3 x upper limit of normal
- Alanine aminotransferase (ALT) ≤3 x upper limit of normal
- Alkaline phosphatase ≤2.5 x upper limit of normal
- Serum creatinine ≤1.5 x upper limit of normal or estimated creatinine clearance >30 mL/min according to Cockcroft-Gault formula
- Hemoglobin >9 g/dL
- Absolute neutrophil count ≥1.5 x10^9/L
- Platelet count ≥75 x10^9/L
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Able to provide informed consent
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Acceptable candidate for curative intent radiotherapy and Cemiplimab immunotherapy, in opinion of radiation and medical oncologist, respectively
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Life expectancy >18 months
Exclusion Criteria:
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Primary tumor originating on the mucosal (non-hair bearing) lip or nose, anogenital (penis, scrotum, vulva, perianal) area
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Iatrogenic immunosuppression (>prednisone 10 mg/day or equivalent within 14 days of initiation of treatment)
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Women of child bearing potential unwilling or unable to use effective contraception while receiving treatment with cemiplimab and for 4 months thereafter
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Distant metastases
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Clinically significant autoimmune disease that requires iatrogenic immunosuppression
o For example, severe rheumatoid arthritis requiring disease modifying antirheumatic drugs, such as methotrexate
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Current or previous hematopoietic malignancy (leukemia, lymphoma)
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Prior allogeneic transplant of solid organ or bone marrow
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Concurrent malignancies with >10% risk of metastasis or death within 2 years
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Prior aPD1 immunotherapy or PI3Kδ inhibitor use
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Prior radiotherapy for the cutaneous squamous cell carcinoma requiring treatment
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Other ongoing cancer therapy
o Adjuvant endocrine therapy is permitted for patients with prostate or breast cancer
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Uncontrolled HIV or infectious hepatitis (viral load detectable in patient with known infection)
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Pregnancy or breastfeeding
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Comorbid or diagnostic abnormalities within the last year that would interfere with interpretation of study results
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC
Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC |
Participants will undergo baseline imaging, followed by two doses of neoadjuvant cemiplimab at a dose of 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days). Then, participants will receive concurrent cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) concurrently with RT to 70 Gy in 35 fractions over 7 weeks. Thereafter, participants will receive 38 weeks of cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) for a cumulative total of 12 months of cemiplimab. Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Event Free Survival
Délai: 18 months
|
The primary endpoint for this study is event free survival at 18 months (week 78 +/- 3 weeks) after starting cemiplimab. |
18 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Christopher Barker, MD, Memorial Sloan Kettering Cancer Center
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- Cancer de la peau
- Centre de cancérologie Memorial Sloan Kettering
- carcinome squameux
- Carcinome épidermoïde cutané
- carcinome épidermoïde localement avancé
- Carcinome épidermoïde localement avancé de la peau
- Carcinome épidermoïde cutané localement avancé
- Carcinome épidermoïde cutané localement avancé
- cémiplimab
- REMPART
- 22-090
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 22-090
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Informations sur les médicaments et les dispositifs, documents d'étude
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