The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer

Primary Objective: •To assess feasibility and success of an organ-sparing strategy in patients with localized dMMR colorectal cancer receiving neoadjuvant cemiplimab. The primary endpoint is rate of endoCR by 6 months. Exploratory Objectives: - To quantify organ-sparing rate at 1 year for all patients treated with one dose of cemiplimab (intent to treat) - To quantify the composite rate of either non-operative management at 1 year or pathological complete response for all patients treated with one dose of cemiplimab (intent to treat) - To quantify the composite rate of either endoCR by 6 months or pathologic complete response for all patients treated with one dose of cemiplimab (intent to treat) - To assess and describe features observed on endoscopy after neoadjuvant cemiplimab - To assess radiographic response to neoadjuvant cemiplimab - To estimate the relapse-free survival, progression-free survival and overall survival in all enrolled participants - To determine the overall rates of pathological response to neoadjuvant cemiplimab in patients who undergo resection after receiving at least one dose of cemiplimab - To determine overall safety of cemiplimab for patients with localized colon cancer - To determine the change in patient-reported symptoms with cemiplimab - To explore the predictive ability of changes in ctDNA for efficacy endpoints - To determine if total mutational burden and genomic alterations correlate with response and extent of benefit from cemiplimab - To correlate tumor-immune microenvironment (for example T-effector cell populations; CD4 subsets; T-regulatory populations; B cell populations; dendritic and macrophage populations) in pre-treatment tumor samples with efficacy endpoints - To compare targeted gene expression profiles of immune-related genes and genes pertaining to common cancer signaling pathways in pre-treatment samples as well as the change in these factors (for cases with both pre-treatment and on-treatment tumor samples) between responders and non-responders

Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca

Eligible patients will receive 3 cycles/9 weeks of Cemiplimab (IV infusion) prior to curative treatment, with or without Carboplatin/Paclitaxel. The addition of carboplatin and paclitaxel depends on the presence of measurable benefit to participant. Assessments of patient progress are conducted weekly by multidisciplinary team and at week 9 or 10 a de-escalation decision will also be used to determine if patient receives de-escalated or non-minimally de-escalated treatment. De-Escalated Treatment: Transoral Robotic Surgery (TORS) or Low Dose Radiation Therapy (42Gy) Non-Minimally De-Escalated Treatment: Surgery + Post-Operative Radiation Therapy or 60 Gy Chemoradiation Therapy Curative intent will be followed by adjuvant Cemiplimab for 4 months (5 doses every 21 days).

Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma

Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).

Primary Objective: - To assess the efficacy of cemiplimab and cetuximab in patients with recurrent oral cavity squamous cell carcinoma Secondary Objective: - To assess safety of cemiplimab and cetuximab prior salvage surgery - To evaluate the efficacy of cemiplimab and cetuximab prior salvage surgery on measures - To estimate the one-year disease free survival (DFS) - To estimate the median overall survival (OS) Tertiary/Exploratory Objective: - To explore patient-reported outcomes (PRO) during CC and following salvage surgical resection - Assess impact of cemiplimab and cetuximab on surgery and adjuvant therapy - To explore biomarkers that may predict response to therapy

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents

This Phase 1-2 study is designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR502, a fully human IgG1 antibody that binds specifically to LILRB2, in subjects with advanced solid tumors. The study consists parts: Part A: a dose-escalation phase to determine the maximum-tolerated dose (MTD), maximum achievable dose, or optimal dose of OR502 for further evaluation as monotherapy and in combination with cemiplimab in a maximum of approximately 48 subjects. Recruitment closed. Part B: an expansion phase in subjects with advanced solid tumors treated with OR502 at 2 separate doses as monotherapy followed by combination with cemiplimab, and in subjects with previously treated platinum-resistant ovarian cancer (PROC) or cutaneous squamous cell carcinoma (CSCC) treated with OR502 at 2 separate doses in combination with cemiplimab. Up to approximately 20 subjects will be treated in each arm of the 3 Part B cohorts to further characterize safety, help determine the recommended Phase 2 dose (RP2D) for further development and determine preliminary anti-tumor activity. Up to approximately 120 subjects total will be treated in Part B. Not yet open. Part B4: a mini-expansion cohort in subjects with a histological diagnosis of cutaneous melanoma with advanced/metastatic disease. Subjects must have received a PD-(L)1 inhibitor-based therapy, either alone or in combination with other anti-cancer agents, for at least 12 weeks. Subjects in this cohort will be treated with OR502 as monotherapy. Actively recruiting. Part B5: a mini-expansion cohort in subjects with a histological diagnosis of non-small cell lung cancer (NSCLC) with advanced/metastatic disease. Subjects must have received a PD-(L)1 inhibitor-based therapy, either alone or in combination with other anti-cancer agents, for at least 12 weeks. Subjects in this cohort will be treated with OR502 in combination with cemiplimab. Actively recruiting.

Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC

A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab