Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
Squamous Cell Carcinoma of the Anal Canal
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Anal Canal focused on measuring Squamous cell carcinoma, carboplatin, paclitaxel, PD-1 Inhibitor, Anal Cancer, SCAC
Eligibility Criteria
Inclusion Criteria:
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 9 months prior to randomization.
- ECOG performance status 0 to 1.
- If HIV-positive, then must be stable as defined by: a. CD4+ count ≥ 200/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
Exclusion Criteria:
- 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 except for palliative radiation (30 Gy or less) which is restricted for 14 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 and IV antibiotic use within 7 days of Cycle 1 Day 1.
- 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
Sites / Locations
- The University of Arizona Cancer Center
- City of Hope National Medical Center
- UC Davis Comprehensive Cancer Center
- Sansum Clinic
- Rocky Mountain Cancer Center
- Ochsner Clinic
- Maryland Oncology Hematology, P.A.
- Mayo Clinic
- Texas Oncology
- Baylor Scott and White Research Institute
- Renovatio Clinical Consultants Llc
- Texas Oncology-Wichita Falls Texoma Cancer Center
- Virginia Cancer Specialists, Pc
- Blue Ridge Cancer Care
- Princess Alexandra Hospital Australia
- Flinders Medical Centre
- Monash Medical Centre Clayton
- Zna Middelheim
- Ulb Hospital Erasme
- Herlev Og Gentofte Hospital
- Vejle Hospital
- Institut de Cancerologie de L Ouest - Site Paul Papin
- Chu Besancon Hospital Jean Minjoz
- Centre Hospitalier Universitaire de Bordeaux
- Centre Leon Berard
- Chu Hopital de La Timone
- Institut Du Cancer de Montpellier
- Centre Antoine Laccassagne
- Hospital Universitaire Pitie-Salpetriere
- Hospital de La Miletrie
- Chu de Rennes - Hospital Pontchaillou
- Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
- Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
- Institut de Cancerologie de Strasbourg
- Chu Toulouse Hopital Rangueil
- Institut Gustave Roussy
- Universitatsklinikum Bonn Aoer
- University Clinic Carl Gustav Carus Technical University Dresden
- Asklepios Klinik Altona
- Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
- European Institute of Oncology
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
- Fondazione Irccs Ca Granda Ospedale Maggiore
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
- University Di Cagliari-Presidio Policlinico Monserrato
- Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli
- Iov - Istituto Oncologico Veneto Irccs
- Azienda Ospedaliero Universitaria Pisana
- Ospedale Degli Infermi
- I.R.C.C.S. Casa Sollievo Della Sofferenza
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- National Cancer Center Hospital
- Kyushu University Hospital
- Saitama Medical University International Medical Center
- Aichi Cancer Center Hospital
- Osaka International Cancer Institute
- Tohoku University Hospital
- Center Hospital of the National Center For Global Health and Medicine
- Haukeland University Hospital
- Oslo Universitetssykehus
- Panoncology Trials Pan American Center For Oncology Trials, Llc
- Complejo Hospitalario Universitario A Coruna
- Hospital General Universitario Vall D Hebron
- Hospital Clinic de Barcelona
- Hospital Universitario 12 de Octubre
- Hospital Universitario de La Paz
- Son Espases University Hospital
- Hospital Universitario Virgen Del Rocio
- Hospital Universitario Miguel Servet
- Sahlgrenska University Hospital
- Skaenes Universitetssjukhus Lund
- Stockholm South General Hospital Sodersjukhuset
- Royal Sussex County Hospital
- Addenbrooke'S Hospital
- Royal Surrey County Hospital
- Castle Hill Hospital
- Leeds Teaching Hospital
- Royal Free London Nhs Foundation Trust
- The Royal Marsden Nhs Foundation Trust - Chelsea
- The Christie Nhs Foundation Trust Uk
- Churchill Hospital
- Royal Preston Hospital
- The Royal Marsden Nhs Foundation Trust - Sutton
- Royal Cornwall Hospital Truro Sunrise Centre
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Group A : carboplatin+paclitaxel+placebo
Group B : carboplatin+paclitaxel+retifanlimab
Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle
Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle