SNS-101 + Cemiplimab for Cancer
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Sensei Biotherapeutics, Inc.
Must not be taking: Anti-PD-1, PD-L1, Chemotherapy, Biologics
Disqualifiers: Brain metastasis, Severe allergies, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a new antibody treatment called SNS-101, alone or with another drug, in patients with advanced cancers. It aims to help the immune system attack cancer cells by blocking a protein that hides them.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as anti-PD-1/PD-L1 therapies, chemotherapy, or other investigational drugs, at least 2 weeks before starting the study. It's best to discuss your specific medications with the trial team to see if they need to be paused.
What data supports the effectiveness of the drug SNS-101 + Cemiplimab for cancer?
Cemiplimab has shown effectiveness in treating advanced cutaneous squamous cell carcinoma and non-small cell lung cancer by improving survival rates and enhancing the immune system's response to tumors. It has been approved for use in these cancers, indicating its potential benefit in treating other types of cancer as well.
12345Is the combination of SNS-101 and Cemiplimab safe for humans?
Cemiplimab, also known as Libtayo, has been shown to have an acceptable safety profile in clinical trials for advanced cutaneous squamous cell carcinoma, with most side effects being manageable. It has been associated with low rates of treatment discontinuation and death, indicating it is generally safe for use in humans.
12367What makes the drug SNS-101 + Cemiplimab unique for cancer treatment?
SNS-101 combined with Cemiplimab is unique because it involves a novel combination of an investigational drug (SNS-101) with Cemiplimab, an existing immune checkpoint inhibitor that targets PD-1 (a protein that helps keep the immune system in check). This combination aims to enhance the immune system's ability to fight cancer, potentially offering a new approach for patients who may not respond to standard treatments.
89101112Eligibility Criteria
This trial is for adults with advanced solid tumors who've tried standard treatments without success or can't receive them. They must have measurable disease, good organ function, and a life expectancy of at least 3 months. Women and men able to have children must use effective birth control. People can't join if they've had certain recent cancer treatments, severe reactions to similar drugs, brain metastases, or are pregnant/breastfeeding.Inclusion Criteria
My cancer is advanced, cannot be surgically removed, or has spread.
My cancer can be measured by tests.
Life expectancy of ≥ 3 months
+5 more
Exclusion Criteria
I haven't had treatment for another cancer within the last 2 years, except for early-stage cancer treated with the aim of cure.
I experienced severe side effects from previous immunotherapy.
I haven't used specific therapies in the last 2 weeks.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phase 1 Monotherapy Dose Escalation and Dose Expansion
SNS-101 is administered alone every 21 days to determine safety, tolerability, and optimal dosing
Approximately 15 months
Every 21 days
Phase 1 Combination Dose Escalation and Dose Expansion
SNS-101 is administered in combination with cemiplimab every 21 days to determine safety, tolerability, and optimal dosing
Approximately 15 months
Every 21 days
Phase 2 Cohort Expansion
SNS-101 is administered alone or in combination with cemiplimab to evaluate efficacy in specific tumor types
Approximately 1 year
Every 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
90 days after the last dose
Participant Groups
The study tests SNS-101 (an anti-VISTA antibody) alone or with Cemiplimab in patients with various advanced cancers. It aims to assess the safety and effectiveness of these therapies while monitoring how the body processes them.
3Treatment groups
Experimental Treatment
Group I: Part C - Cohort Expansion - SNS-101 alone or in combination with cemiplimabExperimental Treatment2 Interventions
SNS-101 IV alone or in combination with cemplimab IV every 21 days at the RP2D.
Group II: Part B - SNS-101 in combination with cemiplimab and Dose ExpansionExperimental Treatment2 Interventions
SNS-101 IV and cemiplimab IV every 21 days. Patients will initially enroll in dose escalation cohorts.
Group III: Part A - SNS-101 Monotherapy Dose Escalation and Dose ExpansionExperimental Treatment1 Intervention
SNS-101 IV alone every 21 days. Patients will initially enroll in dose escalation cohorts.
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
🇪🇺 Approved in European Union as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
🇺🇸 Approved in United States as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
🇨🇦 Approved in Canada as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
🇧🇷 Approved in Brazil as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLA Hematology/OncologyLos Angeles, CA
University of Pennsylvania, Perelman Center for Advanced MedicinePhiladelphia, PA
Icahn School of Medicine at Mt. SinaiNew York, NY
Norton HealthcareLouisville, KY
More Trial Locations
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Who Is Running the Clinical Trial?
Sensei Biotherapeutics, Inc.Lead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
References
Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. [2023]In metastatic non-small cell lung cancer (NSCLC), tumors that do not harbor driver mutations in EGFR or gene fusions in ALK and ROS, PD-1 and PD-L1 inhibitors have become a cornerstone in first line treatment, either as monotherapy or in combination with chemotherapy. This paper reviews cemiplimab-rwlc, the third PD-1/L1 inhibitor to be approved in the setting for first line treatment in NSCLC, as monotherapy or in combination therapy with chemotherapy, to provide a perspective on the subtle differences in patient population for the cemiplimab studies and consideration of its primary and subgroup results in the context of first line therapies for NSCLC.
Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]Introduction: In September of 2018, the United States Federal Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for advanced cutaneous squamous cell carcinoma (CSCC). Cemiplimab is an intravenous human monoclonal antibody directed against programmed cell death-1 receptor (PD-1). Cemiplimab blocks T-cell inactivation and enhances the immune system's anti-tumor response. Areas Covered: We review CSCC and the studies leading to cemiplimab's approval, including common side effects and safety issues experienced during the clinical trials. Expert Opinion: Immunotherapy, specifically checkpoint inhibitors, represents an increasingly utilized class of medications that is proving to be an effective treatment option for those with certain cancers. Over time, immunotherapy is likely to be the standard of care for immune-sensitive tumors. There are many challenges that the field faces, including the identification of reliable biomarkers to better predict response, decreasing toxicity, and the potential treatment of organ transplant patients.
Cemiplimab: First Global Approval. [2023]Cemiplimab (LIBTAYO®; cemiplimab-rwlc), a human programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and blocks its interaction with programmed death ligands 1 (PD-L1) and 2 (PD-L2), is being developed by Regeneron Pharmaceuticals and Sanofi Genzyme. The drug is being investigated as a treatment for various cancers and in September 2018 received approval in the USA for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. This article summarizes the milestones in the development of cemiplimab leading to this first global approval for the treatment of advanced cutaneous squamous cell carcinoma.
Comparative efficacy of cemiplimab versus other systemic treatments for advanced cutaneous squamous cell carcinoma. [2021]Aim: To estimate the comparative efficacy of cemiplimab, a programmed cell death protein 1 inhibitor, versus EGFR inhibitors, pembrolizumab and platinum-based chemotherapy in terms of overall survival (OS) and progression-free survival. Patients & methods: We performed an indirect treatment comparison of cemiplimab and other available systemic therapies for patients with advanced cutaneous squamous cell carcinoma. Results: Cemiplimab was associated with benefits in OS (hazard ratios range: 0.07-0.52) and progression-free survival (hazard ratios range: 0.30-0.67) versus EGFR inhibitors and pembrolizumab (data from KEYNOTE-629). Cemiplimab was more efficacious versus platinum-based chemotherapy in terms of OS. Conclusion: Cemiplimab may offer improvements in survival for advanced cutaneous squamous cell carcinoma patients compared with existing systemic therapies.
First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial. [2023]Cemiplimab provided significant survival benefit to patients with advanced non-small-cell lung cancer with PD-L1 tumour expression of at least 50% and no actionable biomarkers at 1-year follow-up. In this exploratory analysis, we provide outcomes after 35 months' follow-up and the effect of adding chemotherapy to cemiplimab at the time of disease progression.
Cemiplimab in advanced cutaneous squamous cell carcinoma. [2022]Cemiplimab, a high-affinity, highly potent human monoclonal antibody that binds to the programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) receptor, is the only drug to attain Food and Drug Administration (FDA) approval and marketing authorization from the European Commission for use in patients with metastatic and locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation therapy as a first- or later-line treatment. In pivotal phase II clinical testing, cemiplimab showed rapid and substantial antitumor efficacy and acceptable safety. This systematic review was aimed at evaluating the efficacy and safety of cemiplimab in patients with advanced CSCC. To this end, I reviewed EMBASE, MEDLINE, PubMed, and clinical trial registries/databases by using the following keywords alone or in combination: "cemiplimab," "Libtayo," "cutaneous squamous cell carcinoma," "REGN2810," and "SER439684." Cemiplimab showed clinical efficacy and considerable safety and was associated with low rates of treatment discontinuation (7%) and death (3%). However, the current recommendation is primarily based on only phase II clinical testing due to the absence of an approved comparator agent.
Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. [2020]Cemiplimab (Libtayo®) is an antibody immunotherapy that stimulates an anti-cancer response via programmed cell death protein-1 (PD-1) blockade. It is the first approved treatment in the USA and EU for patients with locally advanced (laCSCC) or metastatic (mCSCC) cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiotherapy. Approval was based largely on positive results from the phase II EMPOWER-CSCC 1 trial in this patient population. In this pivotal trial, treatment with intravenous cemiplimab 3 mg/kg once every 2 weeks or 350 mg once every 3 weeks resulted in a clinically significant objective response rate across laCSCC and mCSCC patient groups. Furthermore, responses appear to be durable, as the median duration of response has not yet been reached. Similarly, the median overall survival has also not yet been reached as of the latest data cut-off date. The safety and tolerability profile of cemiplimab was acceptable, with most immune-related adverse events being clinically manageable with appropriate therapy or discontinuation of cemiplimab. Overall, cemiplimab has a durable, clinically significant effect and an acceptable tolerability and safety profile. As the first approved treatment for this indication, cemiplimab represents a welcome therapeutic advance for patients with advanced CSCC.
Phase I/II Trial of Immunotherapy With Durvalumab and Tremelimumab With Continuous or Intermittent MEK Inhibitor Selumetinib in NSCLC: Early Trial Report. [2021]Current strategies to improve clinical outcomes in v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog-mutant non-small-cell lung cancer (NSCLC) patients include mitogen-activated protein kinase kinase 1 inhibitor and programmed death (PD) 1 (PD-1)/PD ligand 1 (PD-L1) immune checkpoint blockade combinations. Experience from treatment of melanoma suggests that anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and anti-PD-1/PD-L1 combinations improve outcomes, but similar benefits remain to be seen for treatment of NSCLC. This report describes a single center, investigator-initiated phase I/II clinical trial to compare 2 combination schedules of intermittent or continuous selumetinib (AZD6244, ARRY-142886), tremelimumab (anti-CTLA-4), and durvalumab (anti-PD-L1) treatment with historical controls in patients with previously treated, unresectable NSCLC. Forty patients will be accrued at the University of Texas M.D. Anderson Cancer Center. Primary objectives include maximum tolerated dose (dose escalation phase) and progression-free survival (dose expansion phase). Secondary objectives include response rate according to Response Evaluation Criteria In Solid Tumors version 1.1, disease control rate, overall survival, safety, and duration of response. Exploratory objectives are to assess biomarkers of response and resistance on the basis of biopsies and peripheral blood taken before and after treatment using immune profiling, transcriptome, and protein readouts.
Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12). [2022]The standard chemotherapy for squamous NSCLC (sqNSCLC) includes platinum plus gemcitabine. Sintilimab, an anti-programmed cell death protein 1 antibody, plus platinum and gemcitabine (GP) has revealed encouraging efficacy as first-line therapy for sqNSCLC in a phase 1b study. We conducted a randomized, double-blind, phase 3 study to further compare the efficacy and safety of sintilimab with placebo, both in combination with GP.
Cetuximab plus gemcitabine and cisplatin compared with gemcitabine and cisplatin alone in patients with advanced pancreatic cancer: a randomised, multicentre, phase II trial. [2022]Preclinical data have suggested a synergistic effect of cetuximab combined with gemcitabine and cisplatin and clinical data have shown a substantial improvement in response and survival when gemcitabine is combined with a platinum analogue compared with gemcitabine alone. The aim of this study was to assess the activity and feasibility of a combination of cetuximab with gemcitabine and cisplatin compared with use of gemcitabine and cisplatin alone for the treatment of advanced pancreatic cancer.
Synergistic antitumor activity of TRAIL combined with chemotherapeutic agents in A549 cell lines in vitro and in vivo. [2006]To investigate the synergistic cytotoxicity of TRAIL in combination with chemotherapeutic agents in A549 cell lines, we systematically evaluated the cytotoxicity of TRAIL alone and TRAIL in combination with cisplatin, paclitaxel (Taxol) or actinomycin D in A549 cell lines in vitro and in vivo, and whether the sensitivity was correlated with the expression level of TRAIL receptors.
[Two cases with recurrent non-small cell lung cancer successfully treated with cisplatin and S-1]. [2016]We report two cases with recurrent non-small cell lung cancer (NSCLC) successfully treated with cisplatin and S-1 after multiple chemotherapy. A 64-year-old woman was diagnosed with adenocarcinoma, yield-T4N2M1, stage IV. She was treated with cisplatin 60 mg/m(2) (day 8) and S-1 80 mg/m(2) (days 1-21) as sixth-line chemotherapy after treatment with paclitaxel and irinotecan, cisplatin and gemcitabine, docetaxel, gefitinib, and vinorelbine. Chest computed tomography (CT) showed partial response of recurrent tumors. Another woman (56 years old) was diagnosed with adenocarcinoma, yield-T0N1M1, stage IV. She was also treated with cisplatin and S-1 as fourth-line chemotherapy after treatment with nedaplatin and gemcitabine, docetaxel and irinotecan, and gefitinib. Chest CT showed a partial response of recurrent tumors. Additionally, we retrospectively reviewed 10 cases with recurrent NSCLC treated with cisplatin and S-1 during the same period. Grade 3 to 4 hematologic toxicity included neutropenia in 30% of these 10 patients, thrombocytopenia in 20%, and anemia in 60%. Grade 3 non-hematologic toxicity included hyperglycemia and hyponatremia in 20% of the 10 patients. All side effects were manageable and there was no case of treatment-related death. Cisplatin combined with S-1 could be an option for recurrent NSCLC.