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Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2) - INCMGA00012-303 (POD1UM-303)

Studio Clinico

Patologia: Neoplasie del retto e ano

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Able to comprehend and willing to sign a written ICF for the study.
- Are 18 years of age or older (or as applicable per local country requirements).
- Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC.
- No prior systemic therapy other than the following:
    a. Chemotherapy administered concomitantly with radiotherapy as a radiosensitizing agent is permitted.
    b. Prior neoadjuvant or adjuvant therapy if completed ≥ 6 months before study entry.
- Has measurable disease per RECIST v1.1 as determined by local site investigator/radiology assessment. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion.
- Able and willing to provide adequate tissue sample and whole blood sample with central testing result prior to randomization. Biopsy for archival samples should have occurred within 6 months prior to randomization.
- ECOG performance status 0 to 1.
- If HIV-positive, then must be stable as defined by: a. CD4+ count ≥ 300/μL, b. Undetectable viral load per standard of care assay, c. Receiving antiretroviral therapy (ART/HAART) for at least 4 weeks prior to study enrollment, and have not experienced any HIV-related opportunistic infection for at least 4 weeks prior to study enrollment.
- Willingness to avoid pregnancy or fathering children.

Criteri di esclusione: 

- Has received prior PD-(L)1 directed therapy
- Has received prior radiotherapy with or without radiosensitizing chemotherapy within 28 days of Cycle 1 Day 1 (note: all toxicities associated should have resolved to Grade ≤ 1).
- Participants with laboratory outside of the protocol defined ranges.
- History of second malignancy within 3 years (with exceptions).
- Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
- Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
- Receipt of a live vaccine within 28 days of planned start of study therapy.
- History of organ transplant, including allogeneic stem cell transplantation.
- Known active CNS metastases and/or carcinomatous meningitis.
- Known hypersensitivity to platinum, paclitaxel, another monoclonal antibody, or any of the excipients that cannot be controlled with standard measures (eg, antihistamines, corticosteroids).
- Participant is pregnant or breastfeeding.
- Current use of protocol defined prohibited medication.
- Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5.
- Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements. 

Trattamento sperimentale: 

Retifanlimab

Trattamento di controllo: 

Carboplatino/Paclitaxel

Centri partecipanti

Nord Italia

IRCCS Ca' Granda Ospedale Maggiore Policlinico
Via Francesco Sforza 35 - 20122 Milano - MI

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
NB: Arruolamento pazienti non ancora attivo

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
NB: Arruolamento pazienti non ancora attivo

 

Ospedale Niguarda Ca' Granda
Piazza dell'Ospedale Maggiore 3 - 20162 Milano - MI
NB: Arruolamento pazienti non ancora attivo

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
NB: Arruolamento pazienti non ancora attivo

 

Presidio Ospedaliero di Faenza
Viale Stradone 9 - 48018 Faenza - RA
Osepdale degli Infermi - NB: Arruolamento pazienti non ancora attivo

 

Centro Italia

Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN
NB: Arruolamento pazienti non ancora attivo

 

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI

 

Sud Italia e isole

AOU di Cagliari - Presidio Policlinico Monserrato
St.Statale 554, Km 4500 - 09100 Monserrato - CA
NB: Arruolamento pazienti non ancora attivo

 

IRCCS Ospedale Casa Sollievo della Sofferenza
Viale Cappuccini 1 - 71013 San Giovanni Rotondo - FG
NB: Arruolamento pazienti non ancora attivo

 

AOU degli studi della Campania Luigi Vanvitelli
Piazza Luigi Miraglia 2 - 80138 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020‐000826‐24

Data di inserimento: 13.07.2021

Promotore

Incyte Corporation

CRO

IQVIA

Principal Investigator ITALIA

Università degli Studi della Campania Luigi Vanvitelli, Napoli

Riferimento: Dr. info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: Napoli

 

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