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Monoclonal Antibodies

REGN6569 + Cemiplimab for Advanced Solid Cancer

Phase 1

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Dose expansion cohorts: Advanced stage (unresectable or metastatic) head and neck squamous cell carcinoma(HNSCC), confirmed histologically or cytologically as defined in the protocol

Dose escalation cohorts: Advanced stage (unresectable or metastatic) solid tumor malignancy, confirmed histologically or cytologically as defined in the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days after the last dose of regn6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

Awards & highlights

Study Summary

This trial is evaluating the safety and efficacy of REGN6956 as monotherapy and in combination with cemiplimab. The primary objective is to assess the safety and tolerability of the combination. Secondary objectives include assessing the preliminary efficacy of the combination as measured by objective response rate, disease control rate, duration of response, progression-free survival, and overall survival.

Who is the study for?

Adults with advanced solid tumors, specifically those with unresectable or metastatic head and neck squamous cell carcinoma who haven't had immune checkpoint blockade therapy, have exhausted all treatment options, and can provide tumor tissue for biopsies. Excluded are those on recent systemic biologics or continuous steroids, with significant autoimmune disease, recent live vaccines (including COVID-19 vaccine within certain time frames), organ transplants, prior GITR-targeted therapy, interstitial lung disease/pneumonitis history, or uncontrolled HIV/Hepatitis.Check my eligibility

What is being tested?

The trial is testing REGN6569 alone and in combination with cemiplimab to evaluate safety and tolerability initially. It aims to measure the effectiveness of this combo by looking at response rates and survival outcomes in patients. The study will also examine how the body processes these drugs and their potential to provoke an immune response.See study design

What are the potential side effects?

Potential side effects may include typical reactions associated with immunotherapy such as inflammation of organs (like colitis), skin reactions (rash), fatigue, possible infusion-related reactions like fever or chills during administration of the drug(s), as well as increased risk of infections due to immune system modulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is an advanced head and neck cancer that cannot be surgically removed.

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My cancer is in an advanced stage and cannot be removed by surgery.

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I have never received immune checkpoint blockade therapy.

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I have tried all approved treatments for my condition with no success.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days after the last dose of regn6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days after the last dose of regn6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days after the last dose of regn6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Characterize percentage change in intratumoral glucocorticoid-induced tumor necrosis factor receptor-Related (GITR)+ Treg density

Incidence and severity of adverse events of special interest (AESIs)

Incidence and severity of grade ≥3 laboratory abnormalities

+4 more

Secondary outcome measures

Disease control rate (DCR)

Drug concentrations of REGN6569 in serum

Drug concentrations of cemiplimab in serum

+6 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Anaemia

20%

Nausea

17%

Fatigue

16%

Vomiting

15%

Decreased appetite

15%

Constipation

11%

Asthenia

11%

Back pain

11%

Pyrexia

11%

Diarrhoea

10%

Arthralgia

Urinary tract infection

Dyspnoea

Abdominal pain

Cough

Oedema peripheral

Hypoalbuminaemia

Headache

Pain in extremity

Rash

Blood creatinine increased

Insomnia

Hypokalaemia

Hypothyroidism

Pruritus

Vaginal haemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Pelvic pain

Stomatitis

Neutropenia

Acute kidney injury

Immune-mediated hepatitis

Autoimmune hepatitis

Febrile neutropenia

Pneumonia

Pyelonephritis

Thrombocytopenia

Neutrophil count decreased

Pyelonephritis acute

White blood cell count decreased

Sepsis

Duodenal ulcer

Haematuria

Hydronephrosis

Hyperpyrexia

Kidney infection

Pneumonitis

Hyperglycaemia

100%

80%

60%

40%

20%

Study treatment Arm

Cemiplimab

Investigator Choice (IC) Chemotherapy

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment2 Interventions

Randomized 1:1 between cohorts Cohort 1: Concurrent start of REGN6569 + cemiplimab Cohort 2: REGN6569 lead-in, then combo therapy

Group II: Dose EscalationExperimental Treatment2 Interventions

REGN6569 lead-in, then combo therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

624 Previous Clinical Trials

381,588 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

264 Previous Clinical Trials

252,121 Total Patients Enrolled

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04465487 — Phase 1

Oral Squamous Cell Carcinoma Research Study Groups: Dose Escalation, Dose Expansion

Oral Squamous Cell Carcinoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT04465487 — Phase 1

Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04465487 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous locations in the US hosting this trial?

"Eight medical centres are currently participating in this trial. These include the Regeneron Research Facility located in Los Angeles, H.Lee Moffitt Cancer Center and Research Institute in Tampa, and Angeles Clinic and Research Institute - Clinic/Outpatient Facility based out of Grand Rapids."

Answered by AI

Has REGN6569 attained licensure from the Federal Drug Administration?

"Due to the limited clinical data attesting its efficacy and safety, REGN6569 received a score of 1 out of 3."

Answered by AI

Does this research endeavor have slots available for prospective participants?

"According to the clinicaltrials.gov portal, this medical trial is currently open for enrollment and was published on October 5th 2020 with its most recent edit occurring June 20th 2022."

Answered by AI

Are there any recorded investigations into the efficacy of REGN6569?

"REGN6569 was first explored at City of Hope 10 years ago, and has since gone through 6 clinical trials. At the moment, there are 56 active studies being conducted in various locations across Los Angeles."

Answered by AI

What is the primary aim of this clinical experiment?

"This medical trial will monitor primary and secondary outcomes over a period of 30 months, with the main objective being to evaluate Incidence and severity of adverse events. Secondary objectives include assessing Drug concentrations for both cemiplimab and REGN6569 in serum samples during Dose escalation periods as well as Duration of Response (DOR)."

Answered by AI

What is the sample size for this research experiment?

"To conduct this experiment, 85 volunteers who meet the eligibility requirements must partake. These participants can join from multiple locations such as Regeneron Research Facility in Los Angeles, California and H.Lee Moffitt Cancer Center and Research Institute in Tampa, Florida."

Answered by AI

What illnesses does REGN6569 typically address?

"REGN6569 is a powerful drug for mitigating the effects of alk gene mutation. It can also lessen the burden associated with conditions such as advanced directives, malignant neoplasms, and metastatic cutaneous squamous cell carcinoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies

2020. "Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04465487.

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