En studie av strålbehandling och Cemiplimab för personer med hudcancer
En fas II, multicenter, enarmad klinisk prövning av strålbehandling och CeMiPlimAb: Rwlc-immunterapi för lokalt avancerad, icke-operbar kutan skivepitelcancer: 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Colorado
-
Aurora, Colorado, Förenta staterna, 80045
- University of Colorado (Data Collection Only)
-
-
Florida
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Tampa, Florida, Förenta staterna, 33612
- Moffitt Cancer Center (Data Collection Only)
-
-
New Jersey
-
Basking Ridge, New Jersey, Förenta staterna, 07920
- Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)
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Middletown, New Jersey, Förenta staterna, 07748
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
-
Montvale, New Jersey, Förenta staterna, 07645
- Memorial Sloan Kettering Bergen (All protocol activities)
-
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New York
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Commack, New York, Förenta staterna, 11725
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
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Harrison, New York, Förenta staterna, 10604
- Memorial Sloan Kettering Westchester (All Protocol Activities)
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New York, New York, Förenta staterna, 10065
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Rockville Centre, New York, Förenta staterna, 11553
- Memorial Sloan Kettering Nassau (All protocol activities)
-
-
Ohio
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic (Data Collection Only)
-
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase Cancer Center (Data Collection Only)
-
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29425
- Medical University of South Carolina
-
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Washington
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Seattle, Washington, Förenta staterna, 98109
- University of Washington (Data Collection Only)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
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
-
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
-
≥18 years old
-
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
-
ECOG ≤2
-
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
-
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
-
Life expectancy >18 months
Exclusion Criteria:
-
Primary tumor originating on the mucosal (non-hair bearing) lip or nose, anogenital (penis, scrotum, vulva, perianal) area
-
Iatrogenic immunosuppression (>prednisone 10 mg/day or equivalent within 14 days of initiation of treatment)
-
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
-
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
-
Concurrent malignancies with >10% risk of metastasis or death within 2 years
-
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)
-
Pregnancy or breastfeeding
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Comorbid or diagnostic abnormalities within the last year that would interfere with interpretation of study results
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Event Free Survival
Tidsram: 18 months
|
The primary endpoint for this study is event free survival at 18 months (week 78 +/- 3 weeks) after starting cemiplimab. |
18 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Christopher Barker, MD, Memorial Sloan Kettering Cancer Center
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 22-090
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
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