carboplatin-paclitaxel with retifanlimab or placebo in participants with locally advanced or metastatic squamous cell anal carcinoma (pod1um-303/interaact 2).

Conditions: Squamous Cell Carcinoma of the Anal Canal

Summary: this study is a phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic scac not previously treated with systemic chemotherapy.


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

Keywords: squamous cell carcinoma carboplatin paclitaxel pd-1 inhibitor anal cancer scac