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Monoclonal Antibodies
REGN4336 + Cemiplimab for Prostate Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
Has progressed upon or intolerant to ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy [ADT]) including at least one second-generation anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide, or darolutamide)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying REGN4336 given alone or with cemiplimab to see how well it works in treating patients with prostate cancer.
Who is the study for?
Adults with advanced prostate cancer that's resistant to castration and has worsened despite treatment, including at least one second-generation anti-androgen therapy. Participants must have a PSA level of ≥4 ng/mL and cannot be on high-dose steroids or have had certain recent treatments like systemic biologics, PSMA-targeting therapies, or suffer from significant autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing REGN4336 alone and combined with Cemiplimab to evaluate safety, tolerability, dosage levels (Dose Escalation), and preliminary effectiveness in reducing tumor size (Dose Expansion) based on objective response rate criteria. It also examines the drugs' pharmacokinetics—their movement through the body.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones for cancer immunotherapy may include fatigue, skin reactions, inflammation in organs such as lungs or intestines (colitis), hormonal gland problems (like thyroid issues), infusion-related reactions, liver inflammation (hepatitis), and potential worsening of pre-existing autoimmune conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is confirmed but not as a pure small cell type.
Select...
My cancer has worsened after 2 or more treatments, including a modern anti-androgen therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of Immune-mediated Adverse Events (imAEs)
Incidence and severity of Serious Adverse Events (SAEs)
Incidence and severity of adverse event of special interest (AESIs)
+3 moreSecondary outcome measures
ADA to REGN4336 and REGN5678
ADA to REGN4336 and cemiplimab
Anti-drug antibodies (ADA) to REGN4336
+11 moreSide effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy
Trial Design
3Treatment groups
Experimental Treatment
Group I: Module 3-Combo TherapyExperimental Treatment3 Interventions
REGN4336 + REGN5678
Group II: Module 2-Combo TherapyExperimental Treatment3 Interventions
REGN4336 + Cemiplimab
Group III: Module 1- MonotherapyExperimental Treatment2 Interventions
REGN4336
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sarilumab
2020
Completed Phase 3
~5980
Cemiplimab
2015
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
620 Previous Clinical Trials
380,095 Total Patients Enrolled
3 Trials studying Prostate Cancer
236 Patients Enrolled for Prostate Cancer
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
262 Previous Clinical Trials
250,904 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer has spread, is resistant to hormone therapy, and my PSA is 4 or higher.I have an autoimmune disease treated with immune-weakening drugs in the last 5 years.My prostate cancer is confirmed but not as a pure small cell type.My cancer has worsened after 2 or more treatments, including a modern anti-androgen therapy.I haven't taken high doses of steroids or similar medicines in the last week.I haven't taken any immune therapy (except Sipuleucel-T) recently.I do not have an uncontrolled HIV, hepatitis B or C, or an immunodeficiency.I haven't had encephalitis, meningitis, severe neurodegenerative disease, or uncontrolled seizures in the last year.I have had treatment targeting PSMA before, but PSMA-targeted radioligand therapy is okay.I've had cancer treatment within the last 3 weeks or am still recovering from side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Module 3-Combo Therapy
- Group 2: Module 1- Monotherapy
- Group 3: Module 2-Combo Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prior experiments have been conducted related to REGN4336?
"In 2010, the City of Hope conducted initial research on REGN4336. Since then, 11 trials have been completed and 56 studies are in progress at multiple locations including Louisville Kentucky."
Answered by AI
To what afflictions is REGN4336 commonly applied?
"REGN4336 is generally prescribed to address alk gene mutation, however it has also demonstrated efficacy in treating metastatic cutaneous squamous cell carcinoma, malignant neoplasms and advance directives."
Answered by AI
How many locations are currently hosting this experiment?
"This clinical trial is hosted at multiple locations, including Norton Cancer Institute in Louisville, KY; Fox Chase Center in Philadelphia, PA; and James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Centre in Columbus, OH. An additional 10 sites are also involved."
Answered by AI
What objectives are this research endeavor striving to accomplish?
"This clinical trial will measure the incidence and severity of immune-related adverse reactions over a 5 year period as its primary outcome. The secondary outcomes include rate of response per PCWG3 criteria in Module 1, ADA to REGN4336 in Module 2 and anti-drug antibodies (ADA) to REGN4336 in Module 3."
Answered by AI
How many individuals are engaging in this clinical experiment?
"Affirmative. According to information accessible on clinicaltrials.gov, this medical experiment was established on November 30th 2021 and is actively recruiting 199 individuals from 10 different sites. There have been recent updates as of October 17th 2022."
Answered by AI
Are there any remaining vacancies in this experiment for participants?
"That is correct. According to the information on clinicaltrials.gov, this medical trial was first advertised on November 30th 2021 and has since been seeking participants. 199 individuals are required at 10 different research locations."
Answered by AI
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