Drobeta - Turnu Severin,, Romania

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

Phase II Trial of Ubamatamab Alone or in Combination with Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies

Primary Objectives • To determine the objective response rate (ORR) and disease control rate (DCR), per RECIST 1.1, of ubamatamab alone and in combination with cemiplimab in patients with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies, RMC or ES, who have progressed on at least one prior line of therapy. Secondary Objectives • To determine the efficacy and safety of ubamatamab alone or in combination with cemiplimab in participants with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies such as RMC or ES who have progressed on at least one prior line of therapy. Efficacy will be measured by overall survival (OS), progression-free survival (PFS), and duration of response (DOR). Exploratory Objectives - To determine the objective response rate (ORR) and disease control rate (DCR), per RECIST 1.1, of the overall strategy of ubamatamab alone followed by combination with cemiplimab in participants with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies, RMC or ES, who have progressed on at least one prior line of therapy. - To evaluate potential biomarkers, such as serum CA-125 and tumor tissue MUC16 expression levels for participant stratification, and to determine via the molecular profiling of biopsy and blood specimens, the mechanisms of resistance to ubamatamab alone or in combination with cemiplimab.

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