- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02868632
Study of Immune Checkpoint Inhibition With Radiation Therapy in Unresectable, Non-metastatic Pancreatic Cancer
A Phase I Study of Immune Checkpoint Inhibition (Anti-CTLA4 and/or Anti-PD-L1) in Combination With Radiation Therapy in Patients With Unresectable and Non-metastatic Pancreatic Cancer
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Patients with unresectable, locally advanced adenocarcinoma of pancreas will receive Stereotactic Body Radiation Therapy (SBRT) at a dose of 6 Gy daily, for 5 days. In Cohort A, where MEDI4736 is given, subjects will receive 10 mg/kg of MEDI4736 every 2 weeks, on the same day as, but after the first dose of SBRT is delivered (within 4 hours). In Cohort B, where tremelimumab is given, subjects will receive 10 mg/kg of tremelimumab every 4 weeks, on the same day as, but after the first dose of SBRT is delivered (within 4 hours). In Cohort C, where MEDI4736 and tremelimumab are given in combination, subjects will receive 10 mg/kg of tremelimumab every 4 weeks, on the same day as, but after the first dose of SBRT is delivered (within 4 hours), followed by 10 mg/kg of MEDI4736 every 4 weeks.
Correlative Studies The investigators will evaluate immune changes in peripheral blood samples and in tumor biopsy fine needle aspirate (FNA) specimens pre- and post- treatment from the 3 cohorts that involve the combination of stereotactic body radiation therapy (SBRT) with either (A) MEDI4736 alone, (B) tremelimumab alone, or (C) the combination of MEDI4736 and tremelimumab. FNA biopsies will be done at baseline (within 30 days of treatment initiation) and Day 28 of cycle 2 (between days 22-28 of cycle 2).
Tipo di studio
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20007
- Georgetown University Medical Center
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New York
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Bronx, New York, Stati Uniti, 10461
- Montefiore Medical Center
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New York, New York, Stati Uniti, 10016
- New York University School of Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion:
- Histopathological confirmation of pancreatic adenocarcinoma prior to study entry.
- Unresectable and non-metastatic disease
- At least 1 measurable metastatic lesion by RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques, or as >10 mm with spiral computed tomography (CT) scan, and that is accessible for biopsy.
- Age >18 years
- ECOG performance status 0-1
- Normal organ and marrow function as defined below:
Absolute Neutrophil Count > 1,000/mcL Platelets ≥ 75,000/mcL Total Bilirubin ≤ 2 x ULN Serum Albumin ≥ 2.5 g/dl ALT or AST up to 3 x ULN if no liver metastases or ALT or AST up to 5 x ULN if liver metastases present Creatinine < 2 x institution upper limit of normal OR Creatinine Clearance > 45 mL/min/1.73 m2, as calculated below, for patients with creatinine levels above institutional normal
- No history of another malignancy in the past 5 years, except for treated non-melanoma skin cancer, superficial bladder cancer, or carcinoma-in-situ of the cervix
- No coexisting medical problems that would limit compliance with the study
- Ability to understand and sign a written informed consent document. Patient must have willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- Female subjects of childbearing potential must have a negative serum pregnancy test prior to study entry
- Female subjects of childbearing potential and males must agree to use a highly effective method of contraception for the duration of study treatment, and for six months after discontinuation of the study drug.
Exclusion:
- Resectable, borderline resectable or metastatic disease
- Prior chemotherapy, targeted therapy, immunotherapy, clinical trials or radiotherapy for pancreatic cancer.
- Active or history of concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens, immunosuppressive agents, other investigational therapies, or chronic use of systemic corticosteroids (inhaled and topical steroids are permitted)
- Active or history of chronic autoimmune disease with symptomatic disease within the 3 years before randomization.
- Active or history of inflammatory bowel disease (colitis, Crohn's disease), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea.
- Diverticulitis within the past 2 years.
- Active HIV infection
- Uncontrolled systemic disease including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Brain metastases
- Patients should not be vaccinated with live attenuated vaccines within 1 month of starting tremelimumab and MEDI4736 treatment.
- History of hypersensitivity reaction to human or mouse antibody products
- Evidence of pre-existing idiopathic pulmonary fibrosis on CT scan at baseline
- Unhealed surgical wound at time of treatment, or history of unhealed surgical wound for more than 30 days
- History of an invasive secondary primary malignancy diagnosed within the previous 3 years, except for appropriately treated stage I endometrial or cervical carcinoma, prostate carcinoma treated surgically or non-melanoma skin cancer.
- Non-protocol antineoplastic agents will not be permitted during this study
- Patients may not recieve other investigational agents.
- Pregnant or lactating women
- Subjects with dementia or significantly altered mental status that would prohibit understanding or rendering of information and consent and compliance with the requirements of the protocol.
- Subjects unable or unwilling to abide by the study protocol or cooperate fully.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Cohort A: MEDI4736 + SBRT
MEDI4736 10 mg/kg IV every 2 weeks plus Stereotactic Body Radiation (SBRT) 6 Gy x 5 Days, 10 Subjects
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anti-PD-L1 human monoclonal antibody
Altri nomi:
Stereotactic body radiation therapy (SBRT) will be administered at the standard dose of 6 Gy daily for 5 days.
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Sperimentale: Cohort B:Tremelimumab + SBRT
Tremelimumab 10 mg/kg IV every 4 weeks plus Stereotactic Body Radiation (SBRT) 6 Gy x 5 Days, 10 Subjects
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Stereotactic body radiation therapy (SBRT) will be administered at the standard dose of 6 Gy daily for 5 days.
anti-CTLA4 human monoclonal antibody
Altri nomi:
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Sperimentale: Cohort C: MEDI4736 + Tremelimumab + SBRT
MEDI4736 + Tremelimumab (recommended phase 2 IV dose for combination) plus Stereotactic Body Radiation (SBRT) 6 Gy x 5 Days, 16 Subjects
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anti-PD-L1 human monoclonal antibody
Altri nomi:
Stereotactic body radiation therapy (SBRT) will be administered at the standard dose of 6 Gy daily for 5 days.
anti-CTLA4 human monoclonal antibody
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Overall Survival
Lasso di tempo: 24 Months
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Kaplan Meier curves will be used to summarize Overall Survival.
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24 Months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Progression-Free Survival
Lasso di tempo: 24 Months
|
Kaplan Meier curves will be used to summarize Progression-Free Survival.
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24 Months
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Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Lasso di tempo: 24 Months
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Response rates will be estimated with exact 95% confidence intervals for each dose level.
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24 Months
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Immune-related Response Criteria (irRC)
Lasso di tempo: 24 Hours
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Kaplan Meier curves will be used to summarize Clinical Benefit Rate.
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24 Hours
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jennifer Wu, MD, NYU Langone Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 14-01317
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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